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Hearing Aids, Counseling and the Significant Other

Primary Purpose

Hearing Loss

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Informational Counseling
Patient Centered Counseling
Sponsored by
VA National Center for Rehabilitative Auditory Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hearing Loss focused on measuring hearing loss, hearing aids, spouses, rehabilitation

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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:

  1. Age 20-85 years;
  2. Intact mental status as assessed by the Mini-Mental State Examination (MMSE; Folstein, Folstein & McHugh, 1975);
  3. 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);
  4. Able to read and respond to English; and
  5. 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.

Sites / Locations

  • Portland VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Arm Label

Informational counseling, patient only

Informational Counseling, couples

Patient Centered Counseling,patient only

Patient Centered Counseling, couples

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

post-use subjective opinions regarding the hearing aids
questionnaires

Secondary Outcome Measures

pre-use hearing aid expectations
questionnaire

Full Information

First Posted
March 6, 2013
Last Updated
December 8, 2014
Sponsor
VA National Center for Rehabilitative Auditory Research
Collaborators
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT01809496
Brief Title
Hearing Aids, Counseling and the Significant Other
Official Title
Auditory Rehabilitation From the Perspective of the Significant Other
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Terminated
Why Stopped
Funding ended
Study Start Date
March 2013 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
VA National Center for Rehabilitative Auditory Research
Collaborators
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss
Keywords
hearing loss, hearing aids, spouses, rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Informational counseling, patient only
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Informational Counseling, couples
Arm Type
Experimental
Arm Description
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.
Arm Title
Patient Centered Counseling,patient only
Arm Type
Experimental
Arm Description
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.
Arm Title
Patient Centered Counseling, couples
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Informational Counseling
Intervention Type
Behavioral
Intervention Name(s)
Patient Centered Counseling
Other Intervention Name(s)
motivational interviewing
Primary Outcome Measure Information:
Title
post-use subjective opinions regarding the hearing aids
Description
questionnaires
Time Frame
4-6 weeks after the hearing aid fitting
Secondary Outcome Measure Information:
Title
pre-use hearing aid expectations
Description
questionnaire
Time Frame
immediately after the intervention at Visit #2 (Day 0)
Other Pre-specified Outcome Measures:
Title
self-efficacy
Description
questionnaires
Time Frame
4-6 weeks after the hearing aid fitting
Title
hearing aid use
Description
datalogging
Time Frame
4-6 weeks after the hearing aid fitting

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
M. Samantha Lewis, PhD
Organizational Affiliation
VA National Center for Rehabilitative Auditory Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Portland VA Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97207
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
5420677
Citation
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.
Results Reference
background
PubMed Identifier
1202204
Citation
Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.
Results Reference
background

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Hearing Aids, Counseling and the Significant Other

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