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Applying the Use of Motivational Tools to Auditory Rehabilitation

Primary Purpose

Hearing Loss

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard-of-Care
Treatment
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hearing Loss focused on measuring hearing loss, hearing aids, motivational interviewing, counseling, rehabilitation

Eligibility Criteria

20 Years - 89 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • VA Portland Health Care System, Portland, OR

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard-of-Care

Treatment

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
April 23, 2013
Last Updated
October 6, 2016
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT01843777
Brief Title
Applying the Use of Motivational Tools to Auditory Rehabilitation
Official Title
Applying the Use of Motivational Tools to Auditory Rehabilitation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

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, motivational interviewing, counseling, rehabilitation

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Standard-of-Care
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Treatment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard-of-Care
Intervention Description
the standard of care in audiologic practice
Intervention Type
Behavioral
Intervention Name(s)
Treatment
Other Intervention Name(s)
Motivational Interviewing
Intervention Description
motivational interviewing
Primary Outcome Measure Information:
Title
Difference in Hours of Hearing Aid Use Between Pre-intervention and Post-intervention
Description
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.
Time Frame
Collected pre-intervention and again at post-intervention appointment occurring between four and six weeks after the intervention date
Secondary Outcome Measure Information:
Title
Difference Between Pre-intervention and Post-intervention Total Score on International Outcome Inventory for Hearing Aids
Description
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.
Time Frame
Collected twice once at pre-intervention visit and once at a post-intervention visit occurring four to six weeks following the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
M. Samantha Lewis, PhD
Organizational Affiliation
VA Portland Health Care System, Portland, OR
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Portland Health Care System, Portland, OR
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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
12467365
Citation
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.
Results Reference
result

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Applying the Use of Motivational Tools to Auditory Rehabilitation

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