Hearing Aids, Counseling and the Significant Other

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the effect of enhanced patient-centered counseling (PCC) and the influence of spousal involvement in pre-fitting counseling on hearing-aid outcomes.

Official Title
-----------------
Auditory Rehabilitation From the Perspective of the Significant Other

Conditions
-----------------
Hearing Loss

Intervention / Treatment
-----------------
* Behavioral: Informational Counseling
* Behavioral: Patient Centered Counseling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Both men and women with hearing loss and their live-in partners will serve as subjects in this study. The subjects with hearing loss will have a mild to moderately-severe hearing loss in both of the ears, will have word recognition scores of 40% or better bilaterally, and will be about to get new hearing aids. Live-in partners may also have up to a moderately-severe degree of hearing loss but cannot have prior experience with hearing aids nor have plans to get hearing aids during the course of their participation in this study. Their word recognition scores should also be 40% or better bilaterally. All subjects also will meet the following additional inclusion criteria: Age 20-85 years; Intact mental status as assessed by the Mini-Mental State Examination (MMSE; Folstein, Folstein & McHugh, 1975); No evidence of any major medical illness requiring long-term assistive care, as determined by the Katz Index of Independence in Activities of Daily Living (Katz, Down, Cash &Grotz, 1970); Able to read and respond to English; and Willing and able to give written informed consent to participate in this investigation. Exclusion Criteria: Failure to satisfy any of the requirements listed above or if their live-in partner fails to meet the criteria.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Informational counseling, patient only<br>The purpose of this experimental group is to evaluate the effectiveness of informational counseling alone. This type of counseling is considered the standard of care in audiologic practice. Patients in this will review this material in detail with a member of the study team for approximately 30 minutes at the second visit. Spouses in this experimental group will be will review material regarding VA services with a member of the study team for about 30 minutes. | Behavioral: Informational Counseling<br> <br> |
| Experimental: Informational Counseling, couples<br>The purpose of this experimental group is to evaluate the influence of spousal involvement when receiving informational counseling. In this manner, both patients and spouses are presented with the same information regarding hearing loss and hearing aids. Couples in this experimental group will be given the same information that the patients in the first group were given. At the second visit, couples in this group will review this information together with a member of the research team for approximately 30 minutes. | Behavioral: Informational Counseling<br> <br> |
| Experimental: Patient Centered Counseling,patient only<br>In order to assess the effects of enhanced patient-centered counseling (PCC), the patients assigned to this group will meet together with either Dr. Lewis or the Research Audiologist for approximately 30 minutes of counseling. In addition to the PCC techniques used in audiology, this counseling also will involve the core components of motivational interviewing. These principles and methods will be used to allow the patient to clearly express his/her expectations of, concerns about, and motivations for hearing-aid use. The spouses in this experimental group will be given information regarding VA services. This material will be reviewed with a member of the research team for about 30 minutes at the second visit. | Behavioral: Patient Centered Counseling<br> <br> * Other names: motivational interviewing;|
| Experimental: Patient Centered Counseling, couples<br>In order to assess the influence of the spouse on the enhanced PCC process, the couples assigned to this group will meet together with either Dr. Lewis or the Research Audiologist for approximately 30 minutes of counseling. This counseling will be conducted with both the patient and the spouse together, giving both partners time to express their thoughts. | Behavioral: Patient Centered Counseling<br> <br> * Other names: motivational interviewing;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| post-use subjective opinions regarding the hearing aids | questionnaires | 4-6 weeks after the hearing aid fitting | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pre-use hearing aid expectations | questionnaire | immediately after the intervention at Visit #2 (Day 0) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rehabilitation, hearing loss, hearing aids, spouses