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| Name | Class |
|---|---|
| American Academy of Otolaryngology-Head and Neck Surgery Foundation | OTHER |
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The primary purpose of the study is to develop and test the preliminary efficacy of a first-in-kind community-based intervention to provide affordable, accessible and effective hearing health care to low-income, minority older adults.
Age-related hearing impairment is strongly associated with poorer communicative functioning and social isolation, but hearing impairment often goes undiagnosed and untreated, particularly among minority and low-income older adults. Novel interventions that translate research on social engagement, minority health, and hearing technology are needed to expand delivery of hearing health care to underserved older adults. The Baltimore Hearing Equality through Accessible Research and Solutions (HEARS) project will develop and pilot a first-in-kind community-based intervention to provide affordable, accessible, and effective hearing health care to minority and low-income older adults and their communication partners. The study will follow a mixed-methods approach that will incorporate quantitative and qualitative components throughout the formative and evaluative processes. Participants and their communication partners will be randomized to an immediate treatment group or a 3-month delayed treatment group. The investigators hypothesize that the intervention is associated with increased social engagement and communication, improved quality of life, and decreased loneliness and third-party disability in the immediate treatment compared to the delayed treatment group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate Treatment Group | Experimental | Immediate treatment with Baltimore HEARS intervention |
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| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Hearing Handicap Inventory for the Elderly (HHIE)-S at 3 Months | Mean change, Unpooled - comparing baseline to 3 month follow-up visit Measure Description: Measure was collected through a one-on-one interview with a trained data collector. Scoring: 0-8 suggests no hearing handicap 10-24 suggests mild-moderate hearing handicap 26-40 suggests significant hearing handicap | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Revised QDS at 3 Months | Mean change, Unpooled - comparing baseline to 3 month follow-up visit [1] Measure Description: Measure was collected through a one-on-one interview conducted by a trained data collector. Survey includes 5 questions, scored Strongly disagree, Slightly disagree, neither, slightly agree, or strongly agree (1, 2, 3, 4, 5) Scoring is from 1 (worst) to 5 (best). Scores were summed across each of the 5 survey questions resulting in a total range of 5 (worst) to 25 (best) Although utilized in multiple studies, including Yueh et al., 2001, there are no numerical anchors for what would represent a clinically important difference. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frank Lin, MD, PhD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weinberg Senior Living Communities | Baltimore | Maryland | 21215 | United States |
| 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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| ID | Title | Description |
|---|---|---|
| FG000 | Immediate Treatment Group | Immediate treatment with Baltimore HEARS intervention Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner 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 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 | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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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 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 | Median |
| 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 at 3 Months | Mean change, Unpooled - comparing baseline to 3 month follow-up visit Measure Description: Measure was collected through a one-on-one interview with a trained data collector. Scoring: 0-8 suggests no hearing handicap 10-24 suggests mild-moderate hearing handicap 26-40 suggests significant hearing handicap | Posted | Mean | Standard Deviation | units on a scale | 3 months |
|
Adverse event data were monitored/assessed through study completion, beginning with the study start in 2/2014 through study completion in 9/2015.
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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 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 | |
|---|---|---|---|---|
| Carrie Nieman | Johns Hopkins University School of Medicine Dept. Otolaryngology-HNS | 3025368362 | cnieman1@jhmi.edu |
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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. |
|
| 3 months |
| Change From Baseline in Revised UCLA at 3 Months | Mean change, Unpooled - comparing baseline to 3 month follow-up visit [1] Measure Description: 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. Perry et al., 1990 uses the following 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 | 3 months |
| Change From Baseline in PHQ-9 at 3 Months | Mean change, Unpooled - comparing baseline to 3 month follow-up visit [1] Measure Description: 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 to 3 months was reported. An increase in the score from baseline to three months (a positive number) indicates a worsening in depression severity. A decrease in the score from baseline to three months (a negative number) indicates a reduction in depression severity. | 3 months |
| Change From Baseline in SF-36 Mental Component at 3 Months | Mean change, Unpooled - comparing baseline to 3 month follow-up visit Data were collected via one-on-one interviews with trained data collectors. Standard scoring can be found at http://www.rand.org/health/surveys\_tools/mos/36-item-short-form/scoring.html. Higher scores indicate better mental health functioning; U.S. population norm: M = 50.0, SD = 10.0, range = [2-74]. | 3 months |
| Change From Baseline in SF-36 Physical Component at 3 Months | Mean change, Unpooled - comparing baseline to 3 month follow-up visit Measure collected via one-on-one interview conducted by trained data collectors. Standard scoring can be found at http://www.rand.org/health/surveys\_tools/mos/36-item-short-form/scoring.html. Higher scores indicate better physical health functioning; U.S. population norm: M = 50, SD = 9.95, range = [4-71]. | 3 months |
| 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. |
| Delayed Treatment Group |
3-month delayed treatment with Baltimore HEARS intervention Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner 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: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Hearing screening threshold | Median | Inter-Quartile Range | dB HL |
|
| HHIE-S (Hearing handicap inventory for the elderly - screening) | Measure was collected through a one-on-one interview with a trained data collector. Scoring: 0-8 suggests no hearing handicap 10-24 suggests mild-moderate hearing handicap 26-40 suggests significant hearing handicap | Median | Inter-Quartile Range | units on a scale |
|
| Revised Quantified Denver Scale of Communication Function (QDS) | Measure was collected through a one-on-one interview conducted by a trained data collector. Survey includes 5 questions, scored Strongly disagree, Slightly disagree, neither, slightly agree, or strongly agree (1, 2, 3, 4, 5) Scoring is from 1 (worst) to 5 (best). The scores from the 5 questions are summed and reported as a total score. The range for the total score is 5 (worst) to 25 (best). Although utilized in multiple studies, including Yueh et al., 2001, there are no numerical anchors for what would represent a clinically important difference. | Median | Inter-Quartile Range | units on a scale |
|
| Revised University of California Los Angeles (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. Perry et al., 1990 uses the following 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 | Median | Inter-Quartile Range | units on a scale |
|
| Patient Health Questionnaire (PHQ) | 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 | Median | Inter-Quartile Range | units on a scale |
|
| Short Form - 36 (SF) -36 mental component (Quality of Life) | Measure collected via one-on-one interview conducted by trained data collectors. Standard scoring can be found at http://www.rand.org/health/surveys\_tools/mos/36-item-short-form/scoring.html. Higher scores indicate better mental health functioning; U.S. population norm: M = 50.0, SD = 10.0, range = [2-74]. | Median | Inter-Quartile Range | units on a scale |
|
| SF-36 physical component (Quality of Life) | Measure collected via one-on-one interview conducted by trained data collectors. Standard scoring can be found at http://www.rand.org/health/surveys\_tools/mos/36-item-short-form/scoring.html. Higher scores indicate better physical health functioning; U.S. population norm: M = 50, SD = 9.95, range = [4-71]. | Median | Inter-Quartile Range | units on a scale |
|
| Delayed Treatment Group |
3-month delayed treatment with Baltimore HEARS intervention Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation. |
|
|
| Secondary | Change From Baseline in Revised QDS at 3 Months | Mean change, Unpooled - comparing baseline to 3 month follow-up visit [1] Measure Description: Measure was collected through a one-on-one interview conducted by a trained data collector. Survey includes 5 questions, scored Strongly disagree, Slightly disagree, neither, slightly agree, or strongly agree (1, 2, 3, 4, 5) Scoring is from 1 (worst) to 5 (best). Scores were summed across each of the 5 survey questions resulting in a total range of 5 (worst) to 25 (best) Although utilized in multiple studies, including Yueh et al., 2001, there are no numerical anchors for what would represent a clinically important difference. | Posted | Mean | Standard Deviation | units on a scale | 3 months |
|
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| Secondary | Change From Baseline in Revised UCLA at 3 Months | Mean change, Unpooled - comparing baseline to 3 month follow-up visit [1] Measure Description: 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. Perry et al., 1990 uses the following 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 | Posted | Mean | Standard Deviation | units on a scale | 3 months |
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| Secondary | Change From Baseline in PHQ-9 at 3 Months | Mean change, Unpooled - comparing baseline to 3 month follow-up visit [1] Measure Description: 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 to 3 months was reported. An increase in the score from baseline to three months (a positive number) indicates a worsening in depression severity. A decrease in the score from baseline to three months (a negative number) indicates a reduction in depression severity. | Posted | Mean | Standard Deviation | units on a scale | 3 months |
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| Secondary | Change From Baseline in SF-36 Mental Component at 3 Months | Mean change, Unpooled - comparing baseline to 3 month follow-up visit Data were collected via one-on-one interviews with trained data collectors. Standard scoring can be found at http://www.rand.org/health/surveys\_tools/mos/36-item-short-form/scoring.html. Higher scores indicate better mental health functioning; U.S. population norm: M = 50.0, SD = 10.0, range = [2-74]. | Posted | Mean | Standard Deviation | units on a scale | 3 months |
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| Secondary | Change From Baseline in SF-36 Physical Component at 3 Months | Mean change, Unpooled - comparing baseline to 3 month follow-up visit Measure collected via one-on-one interview conducted by trained data collectors. Standard scoring can be found at http://www.rand.org/health/surveys\_tools/mos/36-item-short-form/scoring.html. Higher scores indicate better physical health functioning; U.S. population norm: M = 50, SD = 9.95, range = [4-71]. | Posted | Mean | Standard Deviation | units on a scale | 3 months |
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| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | Delayed Treatment Group | 3-month delayed treatment with Baltimore HEARS intervention Baltimore HEARS: Tailored aural rehabilitation for participant and communication partner Baltimore HEARS: Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation. | 0 | 7 | 0 | 7 | 0 | 7 |
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