Applying the Use of Motivational Tools to Auditory Rehabilitation

Not Applicable

Completed

• Conditions: Hearing Loss
• Interventions: Behavioral: Standard-of-Care; Behavioral: Treatment

• Registration Number: NCT01843777
• Lead Sponsor: VA Office of Research and Development

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-04-23
• Study First Submitted QC: 2013-04-30
• Study First Posted: 2013-05-01
• Study Start: 2013-11
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2016-10
• Results First Submitted: 2016-10-06
• Results First Submitted QC: 2016-10-06
• Last Update Submitted: 2016-10-06
• Results First Posted: 2016-10-07
• Last Update Posted: 2016-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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.

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Exclusion Criteria

Failure to satisfy any of the requirements listed as inclusion criteria

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard-of-Care	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.
Treatment	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.

Primary Outcome Measures

Name	Time	Method
Difference in Hours of Hearing Aid Use Between Pre-intervention and Post-intervention	Collected pre-intervention and again at post-intervention appointment occurring between four and six weeks after the intervention date	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

Name	Time	Method
Difference Between Pre-intervention and Post-intervention Total Score on International Outcome Inventory for Hearing Aids	Collected twice once at pre-intervention visit and once at a post-intervention visit occurring four to six weeks following the intervention	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.

Trial Locations

Locations (1)

VA Portland Health Care System, Portland, OR; 🇺🇸 Portland, Oregon, United States