Applying the Use of Motivational Tools to Auditory Rehabilitation

Study Overview
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Brief Summary
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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.

Official Title
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Applying the Use of Motivational Tools to Auditory Rehabilitation

Conditions
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Hearing Loss

Intervention / Treatment
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* Behavioral: Standard-of-Care
* Behavioral: Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: be aged between 20 and 89 years be a first-time hearing-aid user air-conduction pure-tone averages (mean thresholds at 500 Hz, 1000 Hz, and 2000 Hz) of 70 dB HL or less in both ears word-recognition scores of 40% or better in each ear English as their first language have sufficient vision and reading ability have the appropriate cognitive skills to participate in the study as determined by the Mini Mental State Exam, 2nd Edition - Brief Version (Folstein et al., 2010) have been fit by the VA Portland Health Care System Audiology and Speech Pathology Service (ASPS) with two hearing aids which have datalogging capabilities be independent in their completion of activities in daily living, as determined by their score on the Katz Index of Independence in Activities of Daily Living (Katz et al., 1970) have poor adoption of their hearing aids be free of a documented diagnosis in the VA Computerized Patient Record System (CPRS) record of neurological or psychological disorder, such as Alzheimer's disease, schizophrenia, or uncontrolled substance abuse, which would interfere with the completion of the study. Vulnerable populations are not being studied. Exclusion Criteria: Failure to satisfy any of the requirements listed as inclusion criteria

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard-of-Care<br>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. | Behavioral: Standard-of-Care<br>* the standard of care in audiologic practice<br>|
| Experimental: Treatment<br>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. | Behavioral: Treatment<br>* motivational interviewing<br>* Other names: Motivational Interviewing;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | Collected twice once at pre-intervention visit and once at a post-intervention visit occurring four to six weeks following the intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hearing loss, hearing aids, motivational interviewing, counseling, rehabilitation