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The purpose of this study is to compare two different ways of helping first-time hearing-aid users get the most out of their hearing aids and determine if one method is better than the other. One method provides the patient with routine information regarding the care and use of hearing aids the other method uses tools to address patient-specific barriers against and motivators for hearing-aid use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard-of-Care | Active Comparator | The "standard-of-care" control group will review and practice with the audiologist content such as: 1) information on hearing-aid batteries and how to change them, 2) cleaning/daily care of the hearing aids, and 3) inserting and removing the hearing aids. |
|
| Treatment | Experimental | The treatment group, on the other hand, will use a motivational tool (exploring importance) in a manner that is consistent with the spirit of motivational interviewing. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard-of-Care | Behavioral | the standard of care in audiologic practice |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in Hours of Hearing Aid Use Between Pre-intervention and Post-intervention | Hearing aid use was measured by the number of hours of use recorded in the hearing-aid software. This was measured on up to four occasions: Visit #1 to #3 (pre-intervention), and Visit #4 (post-intervention). Average daily hours of hearing aid use was documented at each time point, so that the Visit #4 observation is a measure of the average daily use between the start of intervention (Visit #3) and visit #4. Data logger results were averaged between the left and right hearing aids at each time point and across all three pre-intervention time points. | Collected pre-intervention and again at post-intervention appointment occurring between four and six weeks after the intervention date |
| Measure | Description | Time Frame |
|---|---|---|
| Difference Between Pre-intervention and Post-intervention Total Score on International Outcome Inventory for Hearing Aids | The total score from the International Outcome Inventory for Hearing Aids (IOI-HA; Cox et al., 2000) was used to assess overall hearing-aid outcome. This measure consists of seven items assessing (1) daily hearing-aid use, (2) benefit, (3) residual activity limitation, (4) satisfaction, (5) residual participation restriction, (6) impact (of hearing impairment) on others, and (7) quality of Life. Responses to each question range from 1 (poorest) to 5 (best), for a total score range from 7 points to 35 points. The reported measurement was the change in total score from pre-intervention to post-intervention, with a maximum possible change of 28 points. |
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Inclusion Criteria:
Exclusion Criteria:
Failure to satisfy any of the requirements listed as inclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| M. Samantha Lewis, PhD | VA Portland Health Care System, Portland, OR | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Portland Health Care System, Portland, OR | Portland | Oregon | 97239 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 5420677 | Background | Katz S, Downs TD, Cash HR, Grotz RC. Progress in development of the index of ADL. Gerontologist. 1970 Spring;10(1):20-30. doi: 10.1093/geront/10.1_part_1.20. No abstract available. | |
| 12467365 | Result | Cox RM, Stephens D, Kramer SE. Translations of the International Outcome inventory for Hearing Aids (IOI-HA). Int J Audiol. 2002 Jan;41(1):3-26. doi: 10.3109/14992020209101307. No abstract available. |
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Three subjects were consented but not enrolled into the study because they did not meet the inclusion criteria. One subject withdrew from the study after enrollment but prior to randomization.
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard-of-Care | The "standard-of-care" control group will review and practice with the audiologist content such as: 1) information on hearing-aid batteries and how to change them, 2) cleaning/daily care of the hearing aids, and 3) inserting and removing the hearing aids. Standard-of-Care: the standard of care in audiologic practice |
| FG001 | Treatment | The treatment group, on the other hand, will use a motivational tool (exploring importance) in a manner that is consistent with the spirit of motivational interviewing. Treatment: motivational interviewing |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Per protocol population reported: One subject randomized to the "Treatment" erroneously received "Standard of Care" and is not included in this baseline report.
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard-of-Care | The "standard-of-care" control group will review and practice with the audiologist content such as: 1) information on hearing-aid batteries and how to change them, 2) cleaning/daily care of the hearing aids, and 3) inserting and removing the hearing aids. Standard-of-Care: the standard of care in audiologic practice |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Difference in Hours of Hearing Aid Use Between Pre-intervention and Post-intervention | Hearing aid use was measured by the number of hours of use recorded in the hearing-aid software. This was measured on up to four occasions: Visit #1 to #3 (pre-intervention), and Visit #4 (post-intervention). Average daily hours of hearing aid use was documented at each time point, so that the Visit #4 observation is a measure of the average daily use between the start of intervention (Visit #3) and visit #4. Data logger results were averaged between the left and right hearing aids at each time point and across all three pre-intervention time points. | Standard-of-care group: one subject withdrew prior to the collection of outcome measures and one subject did not give valid data log measurement. These subjects are not included. Treatment: Three subjects did not give valid outcome data log measurement and one did not give a valid baseline measure. These subjects are not included. | Posted | Mean | Standard Deviation | hours | Collected pre-intervention and again at post-intervention appointment occurring between four and six weeks after the intervention date |
|
This was a minimal risk study. Adverse events were only monitored during study visits.
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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 | Standard-of-Care | The "standard-of-care" control group will review and practice with the audiologist content such as: 1) information on hearing-aid batteries and how to change them, 2) cleaning/daily care of the hearing aids, and 3) inserting and removing the hearing aids. Standard-of-Care: the standard of care in audiologic practice |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| M. Samantha Lewis, PhD | National Center for Rehabilitative Auditory Research | 503-220-8262 | 51996 | Michele.Lewis3@va.gov |
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| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| D013812 | Therapeutics |
| D062405 | Motivational Interviewing |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Treatment |
| Behavioral |
motivational interviewing |
|
|
| Collected twice once at pre-intervention visit and once at a post-intervention visit occurring four to six weeks following the intervention |
| BG001 |
| Treatment |
The treatment group, on the other hand, will use a motivational tool (exploring importance) in a manner that is consistent with the spirit of motivational interviewing. Treatment: motivational interviewing |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Title |
|---|
| Description |
|---|
| OG000 | Standard-of-Care | The "standard-of-care" control group will review and practice with the audiologist content such as: 1) information on hearing-aid batteries and how to change them, 2) cleaning/daily care of the hearing aids, and 3) inserting and removing the hearing aids. Standard-of-Care: the standard of care in audiologic practice |
| OG001 | Treatment | The treatment group, on the other hand, will use a motivational tool (exploring importance) in a manner that is consistent with the spirit of motivational interviewing. Treatment: motivational interviewing |
|
|
| Secondary | Difference Between Pre-intervention and Post-intervention Total Score on International Outcome Inventory for Hearing Aids | The total score from the International Outcome Inventory for Hearing Aids (IOI-HA; Cox et al., 2000) was used to assess overall hearing-aid outcome. This measure consists of seven items assessing (1) daily hearing-aid use, (2) benefit, (3) residual activity limitation, (4) satisfaction, (5) residual participation restriction, (6) impact (of hearing impairment) on others, and (7) quality of Life. Responses to each question range from 1 (poorest) to 5 (best), for a total score range from 7 points to 35 points. The reported measurement was the change in total score from pre-intervention to post-intervention, with a maximum possible change of 28 points. | In the standard-of-care group, one subject withdrew from the study prior to the collection of outcome measures. In the treatment group, one subject did not answer one of the questions on the baseline questionnaire, thereby preventing calculation of a total score. This subject's data is therefore not included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | Collected twice once at pre-intervention visit and once at a post-intervention visit occurring four to six weeks following the intervention |
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | Treatment | The treatment group, on the other hand, will use a motivational tool (exploring importance) in a manner that is consistent with the spirit of motivational interviewing. Treatment: motivational interviewing | 0 | 10 | 0 | 10 |
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| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D037001 | Directive Counseling |
| D003376 | Counseling |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |