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| ID | Type | Description | Link |
|---|---|---|---|
| R33DC015062-03 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Deafness and Other Communication Disorders (NIDCD) | NIH |
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Age-related hearing loss is highly prevalent and hearing health care is underutilized. The primary objective of the proposed randomized controlled trial is to investigate the efficacy of a community health worker (CHW)-delivered hearing loss intervention program. A preceding pilot study demonstrated preliminary effectiveness of the intervention program in reducing self-reported hearing handicap, and highlighted its acceptability among the target demographic. The proposed trial will now expand upon lessons learned through previous pilot studies and expand to other affordable residences for low-to-moderate income older adults in Baltimore. Primary outcome measurements will investigate intervention effects on hearing handicap, with secondary measurements investigating effects on domains such as social isolation and quality of life. This trial is a first-in-kind investigation of a novel community-based intervention that addresses hearing loss in a vulnerable, urban population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate Treatment Group | Experimental | Immediate treatment with Baltimore HEARS intervention |
|
| Delayed Treatment Group | Placebo Comparator | 3-month delayed treatment with Baltimore HEARS intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Baltimore HEARS | Behavioral | Tailored aural rehabilitation for participant and communication partner (if applicable) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Hearing Handicap Inventory for the Elderly (HHIE-S) | Measure was collected through a one-on-one interview with a trained data collector. Higher scores indicate increased hearing handicap. Scoring: 0-8 suggests no hearing handicap 10-24 suggests mild-moderate hearing handicap 26-40 suggests significant hearing handicap Change from baseline is reported. An increase in the score from baseline (a positive number) indicates a worsening in hearing handicap. | Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Revised UCLA Loneliness Scale | Measure was collected via a one-on-one interview conducted by a trained data collector. Score is the sum of 20-item self-reported measure. Scores range from 20 to 80. Score ranges: 20-34 - Low degree of loneliness 35-49 - Moderate degree of loneliness 50-64 - Moderately high degree of loneliness 65-80 - High degree of loneliness. Change from baseline is reported. An increase in the score from baseline (a positive number) indicates a worsening in degree of loneliness. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frank R Lin, MD, PhD | Johns Hopkins University | Principal Investigator |
| Carrie L Nieman, MD, MPH | Johns Hopkins University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Catholic Charities | Baltimore | Maryland | 21201 | United States | ||
| Weinberg Senior Living Communities |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 6626295 | Background | Ventry IM, Weinstein BE. Identification of elderly people with hearing problems. ASHA. 1983 Jul;25(7):37-42. No abstract available. | |
| 3718608 | Background | Weinstein BE. Validity of a screening protocol for identifying elderly people with hearing problems. ASHA. 1986 May;28(5):41-5. No abstract available. | |
| Label | URL |
|---|---|
| Description of HHIE - S measure | View source |
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Study recruitment began in April 2018 and ended in October 2019. Participants were recruited from independent senior housing in Baltimore City and County and from Baltimore City senior centers and social centers.
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| ID | Title | Description |
|---|---|---|
| FG000 | Immediate Treatment Group | Immediate treatment with Baltimore HEARS intervention Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable) Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation. |
| FG001 | Delayed Treatment Group | 3-month delayed treatment with Baltimore HEARS intervention Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable) Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 3 Month Follow-up |
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| |||||||||||||||||||||
| 12 Month Follow-up |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Immediate Treatment Group | Immediate treatment with Baltimore HEARS intervention Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable) Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Hearing Handicap Inventory for the Elderly (HHIE-S) | Measure was collected through a one-on-one interview with a trained data collector. Higher scores indicate increased hearing handicap. Scoring: 0-8 suggests no hearing handicap 10-24 suggests mild-moderate hearing handicap 26-40 suggests significant hearing handicap Change from baseline is reported. An increase in the score from baseline (a positive number) indicates a worsening in hearing handicap. | 4 incomplete baseline measures (2 immediate, 2 delayed) 1 obtained hearing aids (1 delayed) 1 withdrew consent (1 immediate) 4 non-study related deaths (3 immediate, 1 delayed) 2 lost to follow up (1 immediate, 1 delayed) 3 incomplete 3 month measures from immediate group | Posted | Mean | Standard Deviation | score on a scale | Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group) |
|
Adverse event data for each participant is collected from Screening to 12 Month Post-Intervention Visit (up to 2 years)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Immediate Treatment Group | Immediate treatment with Baltimore HEARS intervention Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable) Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Carrie Nieman | Johns Hopkins University School of Medicine | 410-502-6965 | cnieman1@jhmi.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 9, 2021 | Sep 16, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 13, 2021 | Aug 13, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C567305 | Age-Related Hearing Impairment 1 |
| D003142 | Communication |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| Baltimore HEARS | Device | Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation. |
|
| Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group) |
| Change From Baseline in Self-reported Depression in Patient Health Questionnaire (PHQ-9) | Measure collected via one-on-one interview conducted by trained data collectors. Total of 9 questions, scored from 0 to 3. The score from each question are summed to a total score, which can range from 0 to 27. Interpretation of Total Score Total Score Depression Severity 0 No depression 1-4 Minimal depression 5-9 Mild depression 10-14 Moderate depression 15-19 Moderately severe depression 20-27 Severe depression. Change from baseline is reported. An increase in the score from baseline (a positive number) indicates a worsening in depression severity. | Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group) |
| Change From Baseline in Short Form-12 (SF-12) Mental Component Score | The 12-Item Short Form Survey (SF-12) was collected through a one-on-one interview with a trained data collector. The 12-Item Short Form Survey (SF-12) measures the construct of self-reported health-related quality of life. Here we report the mental component which relates to mental health functioning. Score ranges from 0-100 with higher scores indicating better mental health functioning. Change from baseline is reported. An increase in the score from baseline (a positive number) indicates a better health state. | Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group) |
| Change From Baseline in Short Form -12 (SF-12) Physical Component Score | The 12-Item Short Form Survey (SF-12) was collected through a one-on-one interview with a trained data collector. The 12-Item Short Form Survey (SF-12) measures the construct of self-reported health-related quality of life. Here we report the physical component which relates to physical health functioning. Score ranges from 0-100 with higher scores indicating better physical health functioning. Change from baseline is reported. An increase in the score from baseline (a positive number) indicates a better health state. | Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group) |
| Change From Baseline in Cohen Social Network Index (SNI): Network Diversity | Change from baseline in total number of high contact roles the participant interacts with at least every 2 weeks (such as family, friends, work). Maximum of 12 roles included on the measure. An increase in the score from baseline (a positive number) indicates a more diverse network. | Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group) |
| Change From Baseline in Cohen Social Network Index (SNI): Social Network Size | Change from baseline in total number of individuals in high contact roles the participant interacts with at least every 2 weeks (such as family, friends, work). .An increase in the number of individuals from baseline (a positive number) indicates an increase in their social network size. | Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group) |
| Change From Baseline in Valuation of Life | This self-reported 13 question measure asks the participant how much they agree or disagree on a 5 point Likert scale when asked a statement about the meaning of life and personal goals. Score ranges from 0 to 65. Higher score means higher value of life. Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher value of life. | Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group) |
| Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Computer Self-Efficacy | A 5 question measure surveying self-reported self-efficacy of computer use on a 5 point Likert scale. Score ranges from 0 to 25. Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher self-efficacy. | Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group) |
| Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Device Self-Efficacy | A 5 question measure surveying self-reported device self-efficacy on a 5 point Likert scale. Score ranges from 0 to 25. Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher self-efficacy. | Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group) |
| Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Listening Device Interest | A 5 question measure surveying self-reported self-efficacy of listening device interest on a 5 point Likert scale. Score ranges from 0 to 25. Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher self-efficacy. | Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group) |
| Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Total Score | This 5 question survey measures listening self efficacy on a 0-10 scale in different situations such as being able to understand a conversation in a quiet room to a crowded restaurant. Participants answer with a higher number the more confident they are in the presented situation. Maximum possible score is 50. Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher self-efficacy. | Baseline and 3 month post-intervention (immediate group) or 3 month post-baseline (delayed group) |
| Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Complex Listening | This measure is the combined score of two questions where a participant self-reported their listening self efficacy on a 0-10 scale in complex listening situations. Participants answer with a higher number the more confident they are in the presented situation. Score ranges from 0 to 20. Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher self-efficacy. | Baseline and 3 month post-intervention (immediate group) or 3 month post-baseline (delayed group) |
| Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Directed Listening | This measure is the combined score of two questions where a participant self-reported their listening self efficacy on a 0-10 scale in complex listening situations. Participants answer with a higher number the more confident they are in the presented situation. Score ranges from 0 to 20. Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher self-efficacy. | Baseline and 3 month post-intervention (immediate group) or 3 month post-baseline (delayed group) |
| Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Dialog in Quiet | This measure is a participant's self-reported listening self efficacy on a 0-10 score scale in a dialog in quiet listening situation. Participants answer with a higher number the more confident they are in the presented situation. Maximum possible score is 10. Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher self-efficacy. | Baseline and 3 month post-intervention (immediate group) or 3 month post-baseline (delayed group) |
| Change From Baseline in Hearing Knowledge | This 5 question measure asks participants about their hearing knowledge based on the information presented in the intervention. The score ranges from 0 to 5. Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates more hearing knowledge. | Baseline and 3 month post-intervention (immediate group) or 3 month post-baseline (delayed group) |
| Change From Baseline in Hearing Handicap Inventory for the Elderly (HHIE-S) | Measure was collected through a one-on-one interview with a trained data collector. Higher scores indicate increased hearing handicap. Scoring: 0-8 suggests no hearing handicap 10-24 suggests mild-moderate hearing handicap 26-40 suggests significant hearing handicap. Change from baseline is reported. An increase in the score from baseline (a positive number) indicates a worsening in hearing handicap. | Baseline and 12 months post-intervention |
| Change From Baseline in Revised UCLA Loneliness Scale | Measure was collected via a one-on-one interview conducted by a trained data collector. Score is the sum of 20-item self-reported measure. Scores range from 20 to 80. Score ranges: 20-34 - Low degree of loneliness 35-49 - Moderate degree of loneliness 50-64 - Moderately high degree of loneliness 65-80 - High degree of loneliness. Change from baseline is reported. An increase in the score from baseline (a positive number) indicates a worsening in degree of loneliness. | Baseline and 12 months post-intervention |
| Change From Baseline in Self-reported Depression in Patient Health Questionnaire (PHQ-9) | Measure collected via one-on-one interview conducted by trained data collectors. Total of 9 questions, scored from 0 to 3. The score from each question are summed to a total score, which can range from 0 to 27. Interpretation of Total Score Total Score Depression Severity 0 No depression 1-4 Minimal depression 5-9 Mild depression 10-14 Moderate depression 15-19 Moderately severe depression 20-27 Severe depression. Change from baseline is reported. An increase in the score from baseline (a positive number) indicates a worsening in depression severity. | Baseline and 12 months post-intervention |
| Change From Baseline in Short Form -12 (SF-12) Mental Component Score | The 12-Item Short Form Survey (SF-12) was collected through a one-on-one interview with a trained data collector. The 12-Item Short Form Survey (SF-12) measures the construct of self-reported health-related quality of life. Here we report the mental component which relates to mental health functioning. Score ranges from 0-100 with higher scores indicating better mental health functioning. Change from baseline is reported. An increase in the score from baseline (a positive number) indicates a better health state. | Baseline and 12 months post-intervention |
| Change From Baseline in Short Form -12 (SF-12) Physical Component Score | The 12-Item Short Form Survey (SF-12) was collected through a one-on-one interview with a trained data collector. The 12-Item Short Form Survey (SF-12) measures the construct of self-reported health-related quality of life. Here we report the physical component which relates to physical health functioning. Score ranges from 0-100 with higher scores indicating better physical health functioning. Change from baseline is reported. An increase in the score from baseline (a positive number) indicates a better health state. | Baseline and 12 months post-intervention |
| Change From Baseline in Cohen (Social Network Index) SNI: Network Diversity | Change from baseline in total number of high contact roles the participant interacts with at least every 2 weeks (such as family, friends, work). Maximum of 12 roles included on the measure. An increase in the number of roles from baseline (a positive number) indicates a more diverse network. | Baseline and 12 months post-intervention |
| Change From Baseline in Cohen Social Network Index (SNI): Social Network Size | Change from baseline in total number of individuals in high contact roles the participant interacts with at least every 2 weeks (such as family, friends, work). .An increase in the number of individuals from baseline (a positive number) indicates an increase in their social network size. | Baseline and 12 months post-intervention |
| Change From Baseline in Valuation of Life | This self-reported 13 question measure asks the participant how much they agree or disagree on a 5 point Likert scale when asked a statement about the meaning of life and personal goals. Score ranges from 0 to 65. Higher score means higher value of life. Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher value of life. | Baseline and 12 months post-intervention |
| Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Device Self-Efficacy | A 5 question measure surveying self-reported device self-efficacy on a 5 point Likert scale. Score ranges from 0 to 25. Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher self-efficacy. | Baseline and 12 months post-intervention |
| Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Computer Self-Efficacy | A 5 question measure surveying self-reported self-efficacy of computer use on a 5 point Likert scale. Score ranges from 0 to 25. Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher self-efficacy. | Baseline and 12 months post-intervention |
| Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Listening Device Interest | A 5 question measure surveying self-reported self-efficacy of listening device interest on a 5 point Likert scale. Score ranges from 0 to 25. Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher self-efficacy. | Baseline and 12 months post-intervention |
| Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Total Score | This 5 question survey measures listening self efficacy on a 0-10 scale in different situations such as being able to understand a conversation in a quiet room to a crowded restaurant. Participants answer with a higher number the more confident they are in the presented situation. Maximum possible score is 50. Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher self-efficacy. | Baseline and 12 months post-intervention |
| Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Complex Listening | This measure is the combined score of two questions where a participant self-reported their listening self efficacy on a 0-10 scale in complex listening situations. Participants answer with a higher number the more confident they are in the presented situation. Score ranges from 0 to 20. Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher self-efficacy. | Baseline and 12 months post-intervention |
| Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Directed Listening | This measure is the combined score of two questions where a participant self-reported their listening self efficacy on a 0-10 scale in directed listening situations. Participants answer with a higher number the more confident they are in the presented situation. Score ranges from 0 to 20. Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher self-efficacy. | Baseline and 12 months post-intervention |
| Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Dialog in Quiet | This measure is a participant's self-reported listening self efficacy on a 0-10 scale in a directed listening situation. Participants answer with a higher number the more confident they are in the presented situation. Maximum possible score is 10. Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher self-efficacy. | Baseline and 12 months post-intervention |
| Change From Baseline in Hearing Knowledge | This 5 question measure asks participants about their hearing knowledge based on the information presented in the intervention. Score ranges from 0 to 5. Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates more hearing knowledge. | Baseline and 12 months post-intervention |
| Baltimore |
| Maryland |
| 21215 |
| United States |
| 2307305 |
| Background |
| Tuley MR, Mulrow CD, Aguilar C, Velez R. A critical reevaluation of the Quantified Denver Scale of Communication Function. Ear Hear. 1990 Feb;11(1):56-61. doi: 10.1097/00003446-199002000-00011. |
| 7431205 | Background | Russell D, Peplau LA, Cutrona CE. The revised UCLA Loneliness Scale: concurrent and discriminant validity evidence. J Pers Soc Psychol. 1980 Sep;39(3):472-80. doi: 10.1037//0022-3514.39.3.472. |
| 3393032 | Background | Stewart AL, Hays RD, Ware JE Jr. The MOS short-form general health survey. Reliability and validity in a patient population. Med Care. 1988 Jul;26(7):724-35. doi: 10.1097/00005650-198807000-00007. No abstract available. |
| 36538311 | Derived | Nieman CL, Betz J, Garcia Morales EE, Suen JJ, Trumbo J, Marrone N, Han HR, Szanton SL, Lin FR. Effect of a Community Health Worker-Delivered Personal Sound Amplification Device on Self-Perceived Communication Function in Older Adults With Hearing Loss: A Randomized Clinical Trial. JAMA. 2022 Dec 20;328(23):2324-2333. doi: 10.1001/jama.2022.21820. |
| 35724253 | Derived | Marrone NL, Nieman CL, Coco L. Community-Based Participatory Research and Human-Centered Design Principles to Advance Hearing Health Equity. Ear Hear. 2022 Jul-Aug 01;43(Suppl 1):33S-44S. doi: 10.1097/AUD.0000000000001183. Epub 2020 Jun 13. |
| Withdrawal by Subject |
|
| Obtained Hearing Aids |
|
| NOT COMPLETED |
|
|
| Delayed Treatment Group |
3-month delayed treatment with Baltimore HEARS intervention Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable) Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Living Arrangement | Count of Participants | Participants |
|
| Education | Count of Participants | Participants |
|
| Monthly Household Income | Count of Participants | Participants |
|
| Montreal Cognitive Assessment | Measure was collected through a one-on-one interview with a trained data collector. The MoCA is a cognitive screening test designed to assist Health Professionals in the detection of mild cognitive impairment and Alzheimer's disease. Not used for diagnostic purposes. Scored from 0-30. Presented scores have been adjusted for low education. Lower scores may be interpreted as more severe cognitive impairment. | 1 survey missing from immediate group. 1 survey refused from immediate group | Mean | Standard Deviation | score on a scale |
|
| Speech-Frequency Pure Tone Average | Measure was collected via a portable audiometer with a trained data collector certified in hearing screening by the study audiologist and study investigator. Audiometric pure tone averages [0.5-4kHz] in both ears | Mean | Standard Deviation | db HL |
|
| Hearing Loss | Count of Participants | Participants |
|
| Prior Hearing Aid Use | Count of Participants | Participants |
|
| HHIE-S (Hearing handicap inventory for the elderly - screening) | Measure was collected through a one-on-one interview with a trained data collector. This measure is a self-reported survey on hearing handicap. Total 10 questions, up to 4 points a question. Lower scores indicate less hearing handicap. Scoring: 0-8 suggests no hearing handicap 10-24 suggests mild-moderate hearing handicap 26-40 suggests significant hearing handicap | 2 incomplete surveys from the immediate group | Mean | Standard Deviation | score on a scale |
|
| UCLA Loneliness Scale | Measure was collected via a one-on-one interview conducted by a trained data collector. 20-item Likert-type scale. Total score is sum of the 20 items, scores range from 20 to 80. Lower values equate to lower levels of loneliness and higher values equate to higher levels of loneliness. Score ranges: 20-34 - Low degree of loneliness 35-49 - Moderate degree of loneliness 50-64 - Moderately high degree of loneliness 65-80 - High degree of loneliness | 5 incomplete surveys not included (3 immediate, 2 delayed) | Mean | Standard Deviation | score on a scale |
|
| Patient Health Questionnaire - Depression Score (PHQ-9) | Measure collected via one-on-one interview conducted by trained data collectors. Total of 9 questions, scored from 0 to 3. The score from each question are summed to a total score, which can range from 0 to 27. Interpretation of Total Score Total Score Depression Severity 0 No depression 1-4 Minimal depression 5-9 Mild depression 10-14 Moderate depression 15-19 Moderately severe depression 20-27 Severe depression | 8 incomplete surveys not included (3 immediate, 5 delayed) | Mean | Standard Deviation | score on a scale |
|
| Cohen Social Network Index (SNI): Network Diversity | Measure was collected through a one-on-one interview with a trained data collector. This measure is the number of types of high contact roles a participant self reports to have interacted with in the past 2 weeks (family, friends, etc.). Maximum count of 12. | 8 incomplete measures not included (5 immediate, 3 delayed) | Mean | Standard Deviation | number of roles |
|
| Cohen Social Network Index (SNI): Social Network Size | Measure was collected through a one-on-one interview with a trained data collector. This measure is a self-reported number of individuals in a high contact role that a participant has interacted with in the past 2 weeks. Maximum number of 103. | 8 incomplete measures not included (5 immediate, 3 delayed) | Median | Inter-Quartile Range | number of people |
|
| 12-Item Short Form Survey (SF-12): Mental Component Score | The 12-Item Short Form Survey (SF-12) was collected through a one-on-one interview with a trained data collector. The 12-Item Short Form Survey (SF-12) measures the construct of self-reported health-related quality of life. Here we report the mental component which relates to mental health functioning. Score ranges from 0-100 with higher scores indicating better mental health functioning. | 6 incomplete measures not included (3 immediate, 3 delayed) | Mean | Standard Deviation | score on a scale |
|
| 12-Item Short Form Survey (SF-12) Physical Component Score | The 12-Item Short Form Survey (SF-12) was collected through a one-on-one interview with a trained data collector. The 12-Item Short Form Survey (SF-12) measures the construct of self-reported health-related quality of life. Here we report the physical component which relates to physical health functioning. Score ranges from 0-100 with higher scores indicating better physical health functioning. | 6 incomplete measures not included (3 immediate, 3 delayed) | Mean | Standard Deviation | score on a scale |
|
| Rapid Estimate of Adult Literacy in Medicine-Short Form (REALM-SF) | Measure was collected through a one-on-one interview with a trained data collector. This measure is 7-item word recognition test to provide a valid quick assessment of participant health literacy. Score ranges from 0 to 7, higher scores meaning higher health literacy and lower scores meaning lower health literacy. | 1 incomplete measure not included from immediate group | Mean | Standard Deviation | score on a scale |
|
| Adapted from Attitudes Towards Computers Questionnaire (ATCQ): Computer Self Efficacy | Measure was collected via a one- on-one interview conducted by a trained data collector. 5 question survey of self-reported computer self-efficacy on a 5-point Likert scale. Score range: 0 - 25 points. Higher score indicates higher self-efficacy. | Mean | Standard Deviation | score on a scale |
|
| Adapted from Attitudes Towards Computers Questionnaire (ATCQ): Listening Device Interest | Measure was collected via a one- on-one interview conducted by a trained data collector. 5 question survey of self-reported listening device interest on a 5-point Likert scale. Score range: 0 - 25 points. Higher score indicate higher interest. | Mean | Standard Deviation | units on a scale |
|
| Adapted from Attitudes Towards Computers Questionnaire (ATCQ): Listening Device Self Efficacy | Measure was collected via a one- on-one interview conducted by a trained data collector. 5 question survey of self-reported listening device self efficacy on a 5-point Likert scale. Score range: 0-25 points. Higher score indicate higher self efficacy. | 3 incomplete measures not included (1 immedaite, 2 delayed) | Mean | Standard Deviation | units on a scale |
|
| Own Smartphone | Count of Participants | Participants |
|
| Used Computer within past month | Count of Participants | Participants |
|
| Used text or email within the past month | Count of Participants | Participants |
|
| Adapted from Listening Self-Efficacy Questionnaire (LSEQ): Total Score | Measure was collected through a one-on-one interview with a trained data collector. 5 question survey on self reported self-efficacy in different listening situations on a 0-10 scale. A higher score means higher self-efficacy. Maximum score of 50. | 2 incomplete baseline measures in the delayed group | Mean | Standard Deviation | score on a scale |
|
| Adapted from Listening Self-Efficacy Questionnaire (LSEQ): Complex Listening Self- Efficacy | Measure was collected through a one-on-one interview with a trained data collector. This measure is the combined score of two questions where a participant self-reported their listening self efficacy on a 0-10 scale in complex listening situations. Participants answer with a higher number the more confident they are in the presented situation. Score ranges from 0 to 20. | 1 incomplete baseline measure in the delayed group | Mean | Standard Deviation | score on a scale |
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| Adapted from Listening Self-Efficacy Questionnaire (LSEQ): Directed Listening Self-Efficacy | Measure was collected through a one-on-one interview with a trained data collector. This measure is the combined score of two questions where a participant self-reported their listening self efficacy on a 0-10 scale in directed listening situations. Participants answer with a higher number the more confident they are in the presented situation. Score ranges from 0 to 20. | 2 incomplete baseline measures in the delayed group | Mean | Standard Deviation | score on a scale |
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| Adapted from Listening Self-Efficacy Questionnaire (LSEQ): Dialog in Quiet Listening Self-Efficacy | Measure was collected through a one-on-one interview with a trained data collector. This measure has the participant self report their listening self efficacy on a 0-10 scale in a dialog in quiet listening situation. Participants answer with a higher number the more confident they are in the presented situation. Maximum possible score is 10. | 1 incomplete baseline measure in delayed group | Mean | Standard Deviation | score on a scale |
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| Hearing Knowledge | Measure was collected through a one-on-one interview with a trained data collector . This 5 question measure asks participants about their hearing knowledge. Score ranges from 0 to 5. Higher score indicates greater hearing knowledge. | 9 incomplete baseline measures (5 immediate, 4 delayed) | Mean | Standard Deviation | score on a scale |
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Immediate treatment with Baltimore HEARS intervention Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable) Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation. |
| OG001 | Delayed Treatment Group | 3-month delayed treatment with Baltimore HEARS intervention Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable) Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation. |
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| Secondary | Change From Baseline in Revised UCLA Loneliness Scale | Measure was collected via a one-on-one interview conducted by a trained data collector. Score is the sum of 20-item self-reported measure. Scores range from 20 to 80. Score ranges: 20-34 - Low degree of loneliness 35-49 - Moderate degree of loneliness 50-64 - Moderately high degree of loneliness 65-80 - High degree of loneliness. Change from baseline is reported. An increase in the score from baseline (a positive number) indicates a worsening in degree of loneliness. | 5 incomplete baseline measures (3 immediate, 2 delayed) 1 obtained hearing aids (1 delayed) 1 withdrew consent (1 immediate) 4 non-study related deaths (3 immediate, 1 delayed) 2 lost to follow up (1 immediate, 1 delayed) 16 incomplete 3 month measures (11 immediate, 5 delayed) | Posted | Mean | Standard Deviation | score on a scale | Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group) |
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| Secondary | Change From Baseline in Self-reported Depression in Patient Health Questionnaire (PHQ-9) | Measure collected via one-on-one interview conducted by trained data collectors. Total of 9 questions, scored from 0 to 3. The score from each question are summed to a total score, which can range from 0 to 27. Interpretation of Total Score Total Score Depression Severity 0 No depression 1-4 Minimal depression 5-9 Mild depression 10-14 Moderate depression 15-19 Moderately severe depression 20-27 Severe depression. Change from baseline is reported. An increase in the score from baseline (a positive number) indicates a worsening in depression severity. | 8 incomplete baseline measures (3 immediate, 5 delayed) 1 obtained hearing aids (1 delayed) 1 withdrew consent (1 immediate) 4 non-study related deaths (3 immediate, 1 delayed) 2 lost to follow up (1 immediate, 1 delayed) 11 incomplete 3 month measures (9 immediate, 2 delayed) | Posted | Mean | Standard Deviation | score on a scale | Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group) |
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| Secondary | Change From Baseline in Short Form-12 (SF-12) Mental Component Score | The 12-Item Short Form Survey (SF-12) was collected through a one-on-one interview with a trained data collector. The 12-Item Short Form Survey (SF-12) measures the construct of self-reported health-related quality of life. Here we report the mental component which relates to mental health functioning. Score ranges from 0-100 with higher scores indicating better mental health functioning. Change from baseline is reported. An increase in the score from baseline (a positive number) indicates a better health state. | 6 incomplete baseline measures (3 immediate, 3 delayed) 1 obtained hearing aids (1 delayed) 1 withdrew consent (1 immediate) 4 non-study related deaths (3 immediate, 1 delayed) 2 lost to follow up (1 immediate, 1 delayed) 12 incomplete 3 month measures (11 immediate, 1 delayed) | Posted | Mean | Standard Deviation | score on a scale | Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group) |
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| Secondary | Change From Baseline in Short Form -12 (SF-12) Physical Component Score | The 12-Item Short Form Survey (SF-12) was collected through a one-on-one interview with a trained data collector. The 12-Item Short Form Survey (SF-12) measures the construct of self-reported health-related quality of life. Here we report the physical component which relates to physical health functioning. Score ranges from 0-100 with higher scores indicating better physical health functioning. Change from baseline is reported. An increase in the score from baseline (a positive number) indicates a better health state. | 6 incomplete baseline measures (3 immediate, 3 delayed) 1 obtained hearing aids (1 delayed) 1 withdrew consent (1 immediate) 4 non-study related deaths (3 immediate, 1 delayed) 2 lost to follow up (1 immediate, 1 delayed) 12 incomplete 3 month measures (11 immediate, 1 delayed) | Posted | Mean | Standard Deviation | score on a scale | Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group) |
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| Secondary | Change From Baseline in Cohen Social Network Index (SNI): Network Diversity | Change from baseline in total number of high contact roles the participant interacts with at least every 2 weeks (such as family, friends, work). Maximum of 12 roles included on the measure. An increase in the score from baseline (a positive number) indicates a more diverse network. | 5 incomplete measures at baseline (3 immediate, 2 delayed) 1 obtained hearing aids (1 delayed) 1 withdrew consent (1 immediate) 4 non-study related deaths (3 immediate, 1 delayed) 2 lost to follow up (1 immediate, 1 delayed) 17 incomplete 3 month measures (12 immediate, 5 delayed) | Posted | Mean | Standard Deviation | number of roles | Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group) |
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| Secondary | Change From Baseline in Cohen Social Network Index (SNI): Social Network Size | Change from baseline in total number of individuals in high contact roles the participant interacts with at least every 2 weeks (such as family, friends, work). .An increase in the number of individuals from baseline (a positive number) indicates an increase in their social network size. | 5 incomplete baseline measures (3 immediate, 2 delayed) 1 obtained hearing aids (1 delayed) 1 withdrew consent (1 immediate) 4 non-study related deaths (3 immediate, 1 delayed) 2 lost to follow up (1 immediate, 1 delayed) 17 incomplete 3 month measures (12 immediate, 5 delayed) | Posted | Mean | Standard Deviation | number of individuals | Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group) |
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| Secondary | Change From Baseline in Valuation of Life | This self-reported 13 question measure asks the participant how much they agree or disagree on a 5 point Likert scale when asked a statement about the meaning of life and personal goals. Score ranges from 0 to 65. Higher score means higher value of life. Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher value of life. | 7 incomplete baseline measures (3 immediate, 4 delayed) 1 obtained hearing aids (1 delayed) 1 withdrew consent (1 immediate) 4 non-study related deaths (3 immediate, 1 delayed) 2 lost to follow up (1 immediate, 1 delayed) 11 incomplete 3 month measures (10 immediate, 1 delayed) | Posted | Mean | Standard Deviation | score on a scale | Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group) |
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| Secondary | Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Computer Self-Efficacy | A 5 question measure surveying self-reported self-efficacy of computer use on a 5 point Likert scale. Score ranges from 0 to 25. Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher self-efficacy. | 1 obtained hearing aids (1 delayed) 1 withdrew consent (1 immediate) 4 non-study related deaths (3 immediate, 1 delayed) 2 lost to follow up (1 immediate, 1 delayed) 12 incomplete 3 month measures (11 immediate, 1 delayed) | Posted | Mean | Standard Deviation | score on a scale | Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group) |
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| Secondary | Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Device Self-Efficacy | A 5 question measure surveying self-reported device self-efficacy on a 5 point Likert scale. Score ranges from 0 to 25. Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher self-efficacy. | 3 incomplete baseline measures (1 immediate, 2 delayed) 1 obtained hearing aids (1 delayed) 1 withdrew consent (1 immediate) 4 non-study related deaths (3 immediate, 1 delayed) 2 lost to follow up (1 immediate, 1 delayed) 10 incomplete 3 month measures from immediate group | Posted | Mean | Standard Deviation | score on a scale | Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group) |
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| Secondary | Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Listening Device Interest | A 5 question measure surveying self-reported self-efficacy of listening device interest on a 5 point Likert scale. Score ranges from 0 to 25. Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher self-efficacy. | 1 obtained hearing aids (1 delayed) 1 withdrew consent (1 immediate) 4 non-study related deaths (3 immediate, 1 delayed) 2 lost to follow up (1 immediate, 1 delayed) 10 incomplete 3 month measures in immediate group | Posted | Mean | Standard Deviation | score on a scale | Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group) |
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| Secondary | Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Total Score | This 5 question survey measures listening self efficacy on a 0-10 scale in different situations such as being able to understand a conversation in a quiet room to a crowded restaurant. Participants answer with a higher number the more confident they are in the presented situation. Maximum possible score is 50. Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher self-efficacy. | 2 incomplete baseline measures (2 delayed) 1 obtained hearing aids (1 delayed) 1 withdrew consent (1 immediate) 4 non-study related deaths (3 immediate, 1 delayed) 2 lost to follow up (1 immediate, 1 delayed) 12 incomplete 3 month measures (12 immediate) | Posted | Mean | Standard Deviation | score on a scale | Baseline and 3 month post-intervention (immediate group) or 3 month post-baseline (delayed group) |
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| Secondary | Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Complex Listening | This measure is the combined score of two questions where a participant self-reported their listening self efficacy on a 0-10 scale in complex listening situations. Participants answer with a higher number the more confident they are in the presented situation. Score ranges from 0 to 20. Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher self-efficacy. | 1 incomplete baseline measures (1 delayed) 1 obtained hearing aids (1 delayed) 1 withdrew consent (1 immediate) 4 non-study related deaths (3 immediate, 1 delayed) 2 lost to follow up (1 immediate, 1 delayed) 12 incomplete 3 month measures (12 immediate) | Posted | Mean | Standard Deviation | score on a scale | Baseline and 3 month post-intervention (immediate group) or 3 month post-baseline (delayed group) |
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| Secondary | Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Directed Listening | This measure is the combined score of two questions where a participant self-reported their listening self efficacy on a 0-10 scale in complex listening situations. Participants answer with a higher number the more confident they are in the presented situation. Score ranges from 0 to 20. Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher self-efficacy. | 2 incomplete baseline measures (2 delayed) 1 obtained hearing aids (1 delayed) 1 withdrew consent (1 immediate) 4 non-study related deaths (3 immediate, 1 delayed) 2 lost to follow up (1 immediate, 1 delayed) 12 incomplete 3 month measures (12 immediate) | Posted | Mean | Standard Deviation | score on a scale | Baseline and 3 month post-intervention (immediate group) or 3 month post-baseline (delayed group) |
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| Secondary | Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Dialog in Quiet | This measure is a participant's self-reported listening self efficacy on a 0-10 score scale in a dialog in quiet listening situation. Participants answer with a higher number the more confident they are in the presented situation. Maximum possible score is 10. Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher self-efficacy. | 1 incomplete baseline measures (1 delayed) 1 obtained hearing aids (1 delayed) 1 withdrew consent (1 immediate) 4 non-study related deaths (3 immediate, 1 delayed) 2 lost to follow up (1 immediate, 1 delayed) 12 incomplete 3 month measures (12 immediate) | Posted | Mean | Standard Deviation | score on a scale | Baseline and 3 month post-intervention (immediate group) or 3 month post-baseline (delayed group) |
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| Secondary | Change From Baseline in Hearing Knowledge | This 5 question measure asks participants about their hearing knowledge based on the information presented in the intervention. The score ranges from 0 to 5. Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates more hearing knowledge. | 9 incomplete baseline measures (5 immediate, 4 delayed) 1 obtained hearing aids (1 delayed) 1 withdrew consent (1 immediate) 4 non-study related deaths (3 immediate, 1 delayed) 2 lost to follow up (1 immediate, 1 delayed) 14 incomplete 3 month measures (12 immediate, 2 delayed) | Posted | Mean | Standard Deviation | score on a scale | Baseline and 3 month post-intervention (immediate group) or 3 month post-baseline (delayed group) |
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| Secondary | Change From Baseline in Hearing Handicap Inventory for the Elderly (HHIE-S) | Measure was collected through a one-on-one interview with a trained data collector. Higher scores indicate increased hearing handicap. Scoring: 0-8 suggests no hearing handicap 10-24 suggests mild-moderate hearing handicap 26-40 suggests significant hearing handicap. Change from baseline is reported. An increase in the score from baseline (a positive number) indicates a worsening in hearing handicap. | 4 incomplete baseline measure (2 immediate, 2 delayed) 14 withdrew consent (4 immediate, 10 delayed) 6 non-study related deaths (3 immediate, 3 delayed) 13 lost to follow up (8 immediate, 5 delayed) 8 incomplete 12 month measures (6 immediate, 3 delayed) | Posted | Mean | Standard Deviation | score on a scale | Baseline and 12 months post-intervention |
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| Secondary | Change From Baseline in Revised UCLA Loneliness Scale | Measure was collected via a one-on-one interview conducted by a trained data collector. Score is the sum of 20-item self-reported measure. Scores range from 20 to 80. Score ranges: 20-34 - Low degree of loneliness 35-49 - Moderate degree of loneliness 50-64 - Moderately high degree of loneliness 65-80 - High degree of loneliness. Change from baseline is reported. An increase in the score from baseline (a positive number) indicates a worsening in degree of loneliness. | 5 incomplete baseline measure (3 immediate, 2 delayed) 14 withdrew consent (4 immediate, 10 delayed) 6 non-study related deaths (3 immediate, 3 delayed) 13 lost to follow up (8 immediate, 5 delayed) 30 incomplete 12 month measures (19 immediate, 11 delayed) | Posted | Mean | Standard Deviation | score on a scale | Baseline and 12 months post-intervention |
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| Secondary | Change From Baseline in Self-reported Depression in Patient Health Questionnaire (PHQ-9) | Measure collected via one-on-one interview conducted by trained data collectors. Total of 9 questions, scored from 0 to 3. The score from each question are summed to a total score, which can range from 0 to 27. Interpretation of Total Score Total Score Depression Severity 0 No depression 1-4 Minimal depression 5-9 Mild depression 10-14 Moderate depression 15-19 Moderately severe depression 20-27 Severe depression. Change from baseline is reported. An increase in the score from baseline (a positive number) indicates a worsening in depression severity. | 8 missing at baseline (3 immediate, 5 delayed) 14 withdrew consent (4 immediate, 10 delayed) 6 non-study related deaths (3 immediate, 3 delayed) 13 lost to follow up (8 immediate, 5 delayed) 22 Incomplete 12 month measures (8 immediate, 14 delayed) | Posted | Mean | Standard Deviation | score on a scale | Baseline and 12 months post-intervention |
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| Secondary | Change From Baseline in Short Form -12 (SF-12) Mental Component Score | The 12-Item Short Form Survey (SF-12) was collected through a one-on-one interview with a trained data collector. The 12-Item Short Form Survey (SF-12) measures the construct of self-reported health-related quality of life. Here we report the mental component which relates to mental health functioning. Score ranges from 0-100 with higher scores indicating better mental health functioning. Change from baseline is reported. An increase in the score from baseline (a positive number) indicates a better health state. | 6 incomplete at baseline (3 immediate, 3 delayed) 14 withdrew consent (4 immediate, 10 delayed) 6 non-study related deaths (3 immediate, 3 delayed) 13 lost to follow up (8 immediate, 5 delayed) 27 incomplete 12 month measures (12 immediate, 15 delayed) | Posted | Mean | Standard Deviation | score on a scale | Baseline and 12 months post-intervention |
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| Secondary | Change From Baseline in Short Form -12 (SF-12) Physical Component Score | The 12-Item Short Form Survey (SF-12) was collected through a one-on-one interview with a trained data collector. The 12-Item Short Form Survey (SF-12) measures the construct of self-reported health-related quality of life. Here we report the physical component which relates to physical health functioning. Score ranges from 0-100 with higher scores indicating better physical health functioning. Change from baseline is reported. An increase in the score from baseline (a positive number) indicates a better health state. | 6 incomplete at baseline (3 immediate, 3 delayed) 14 withdrew consent (4 immediate, 10 delayed) 6 non-study related deaths (3 immediate, 3 delayed) 13 lost to follow up (8 immediate, 5 delayed) 27 incomplete 12 month measures (12 immediate, 15 delayed) | Posted | Mean | Standard Deviation | score on a scale | Baseline and 12 months post-intervention |
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| Secondary | Change From Baseline in Cohen (Social Network Index) SNI: Network Diversity | Change from baseline in total number of high contact roles the participant interacts with at least every 2 weeks (such as family, friends, work). Maximum of 12 roles included on the measure. An increase in the number of roles from baseline (a positive number) indicates a more diverse network. | 5 incomplete at baseline (3 immediate, 2 delayed) 14 withdrew consent (4 immediate, 10 delayed) 6 non-study related deaths (3 immediate, 3 delayed) 13 lost to follow up (8 immediate, 5 delayed) 27 incomplete 12 month measures (15 immediate, 12 delayed) | Posted | Mean | Standard Deviation | contact roles | Baseline and 12 months post-intervention |
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| Secondary | Change From Baseline in Cohen Social Network Index (SNI): Social Network Size | Change from baseline in total number of individuals in high contact roles the participant interacts with at least every 2 weeks (such as family, friends, work). .An increase in the number of individuals from baseline (a positive number) indicates an increase in their social network size. | 5 incomplete at baseline (3 immediate, 2 delayed) 14 withdrew consent (4 immediate, 10 delayed) 6 non-study related deaths (3 immediate, 3 delayed) 13 lost to follow up (8 immediate, 5 delayed) 27 incomplete at 12 month (15 immediate, 12 delayed) | Posted | Mean | Standard Deviation | individuals | Baseline and 12 months post-intervention |
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| Secondary | Change From Baseline in Valuation of Life | This self-reported 13 question measure asks the participant how much they agree or disagree on a 5 point Likert scale when asked a statement about the meaning of life and personal goals. Score ranges from 0 to 65. Higher score means higher value of life. Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher value of life. | 7 incomplete baseline (3 immediate, 4 delayed) 14 withdrew consent (4 immediate, 10 delayed) 6 non-study related deaths (3 immediate, 3 delayed) 13 lost to follow up (8 immediate, 5 delayed) 25 incomplete 12 month measures (14 immediate, 11 delay) | Posted | Mean | Standard Deviation | score on a scale | Baseline and 12 months post-intervention |
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| Secondary | Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Device Self-Efficacy | A 5 question measure surveying self-reported device self-efficacy on a 5 point Likert scale. Score ranges from 0 to 25. Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher self-efficacy. | 3 incomplete at baseline (1 immediate, 2 delayed) 14 withdrew consent (4 immediate, 10 delayed) 6 non-study related deaths (3 immediate, 3 delayed) 13 lost to follow up (8 immediate, 5 delayed) 28 incomplete 12 month measures (14 immediate, 14 delay) | Posted | Mean | Standard Deviation | score on a scale | Baseline and 12 months post-intervention |
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| Secondary | Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Computer Self-Efficacy | A 5 question measure surveying self-reported self-efficacy of computer use on a 5 point Likert scale. Score ranges from 0 to 25. Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher self-efficacy. | 0 incomplete baseline (0 immediate, 0 delayed) 14 withdrew consent (4 immediate, 10 delayed) 6 non-study related deaths (3 immediate, 3 delayed) 13 lost to follow up (8 immediate, 5 delayed) 28 incomplete 12 month measures (14 immediate, 14 delayed) | Posted | Mean | Standard Deviation | score on a scale | Baseline and 12 months post-intervention |
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| Secondary | Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Listening Device Interest | A 5 question measure surveying self-reported self-efficacy of listening device interest on a 5 point Likert scale. Score ranges from 0 to 25. Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher self-efficacy. | 0 incomplete at baseline (0) 14 withdrew consent (4 immediate, 10 delayed) 6 non-study related deaths (3 immediate, 3 delayed) 13 lost to follow up (8 immediate, 5 delayed) 28 incomplete 12 month measures (14 immediate, 14 delayed) | Posted | Mean | Standard Deviation | score on a scale | Baseline and 12 months post-intervention |
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| Secondary | Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Total Score | This 5 question survey measures listening self efficacy on a 0-10 scale in different situations such as being able to understand a conversation in a quiet room to a crowded restaurant. Participants answer with a higher number the more confident they are in the presented situation. Maximum possible score is 50. Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher self-efficacy. | 2 incomplete at baseline (0 immediate, 2 delayed) 14 withdrew consent (4 immediate, 10 delayed) 6 non-study related deaths (3 immediate, 3 delayed) 13 lost to follow up (8 immediate, 5 delayed) 28 incomplete 12 month measures (14 immediate, 14 delayed) | Posted | Mean | Standard Deviation | score on a scale | Baseline and 12 months post-intervention |
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| Secondary | Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Complex Listening | This measure is the combined score of two questions where a participant self-reported their listening self efficacy on a 0-10 scale in complex listening situations. Participants answer with a higher number the more confident they are in the presented situation. Score ranges from 0 to 20. Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher self-efficacy. | 1 incomplete at baseline (0 immediate, 1 delayed) 14 withdrew consent (4 immediate, 10 delayed) 6 non-study related deaths (3 immediate, 3 delayed) 13 lost to follow up (8 immediate, 5 delayed) 28 incomplete 12 month measures (14 immediate, 14 delayed) | Posted | Mean | Standard Deviation | score on a scale | Baseline and 12 months post-intervention |
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| Secondary | Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Directed Listening | This measure is the combined score of two questions where a participant self-reported their listening self efficacy on a 0-10 scale in directed listening situations. Participants answer with a higher number the more confident they are in the presented situation. Score ranges from 0 to 20. Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher self-efficacy. | 2 incomplete baseline measure (0 immediate, 2 delayed) 14 withdrew consent (4 immediate, 10 delayed) 6 non-study related deaths (3 immediate, 3 delayed) 13 lost to follow up (8 immediate, 5 delayed) 28 incomplete 12 month measures (14 immediate, 14 delayed) | Posted | Mean | Standard Deviation | score on a scale | Baseline and 12 months post-intervention |
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| Secondary | Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Dialog in Quiet | This measure is a participant's self-reported listening self efficacy on a 0-10 scale in a directed listening situation. Participants answer with a higher number the more confident they are in the presented situation. Maximum possible score is 10. Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher self-efficacy. | 1 incomplete at baseline (0 immediate, 1 delayed) 14 withdrew consent (4 immediate, 10 delayed) 6 non-study related deaths (3 immediate, 3 delayed) 13 lost to follow up (8 immediate, 5 delayed) 29 incomplete 12 month measures (14 immediate, 15 delayed) | Posted | Mean | Standard Deviation | score on a scale | Baseline and 12 months post-intervention |
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| Secondary | Change From Baseline in Hearing Knowledge | This 5 question measure asks participants about their hearing knowledge based on the information presented in the intervention. Score ranges from 0 to 5. Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates more hearing knowledge. | 9 incomplete at baseline (5 immediate, 4 delayed) 14 withdrew consent (4 immediate, 10 delayed) 6 non-study related deaths (3 immediate, 3 delayed) 13 lost to follow up (8 immediate, 5 delayed) 27 incomplete 12 month measures (12 immediate, 15 delayed) | Posted | Mean | Standard Deviation | score on a scale | Baseline and 12 months post-intervention |
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| 6 |
| 78 |
| 0 |
| 78 |
| 0 |
| 78 |
| EG001 | Delayed Treatment Group | 3-month delayed treatment with Baltimore HEARS intervention Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner (if applicable) Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation. | 4 | 73 | 0 | 73 | 0 | 73 |
Not provided
Not provided
Not provided
| NA |
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| White Not Hispanic |
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| Other |
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| More than High School |
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| $50,000 to $74,999 |
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| $75,000 to $99,999 |
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| $100,000 to $149,999 |
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| Don't Know |
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| Refused |
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| Skipped |
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| Don't Know |
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| NA |
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| "I have or use a computer and I used the internet" |
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| Rarely |
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| Not within the past month |
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