Applying the Use of Motivational Tools to Auditory Rehabilitation
1 other identifier
interventional
25
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 23, 2013
CompletedFirst Posted
Study publicly available on registry
May 1, 2013
CompletedStudy Start
First participant enrolled
November 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedResults Posted
Study results publicly available
October 7, 2016
CompletedOctober 7, 2016
October 1, 2016
1.3 years
April 23, 2013
October 6, 2016
October 6, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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
Study Arms (2)
Standard-of-Care
ACTIVE COMPARATORThe "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
EXPERIMENTALThe 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VA Portland Health Care System, Portland, OR
Portland, Oregon, 97239, United States
Related Publications (2)
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.
PMID: 5420677BACKGROUNDCox 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.
PMID: 12467365RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- M. Samantha Lewis, PhD
- Organization
- National Center for Rehabilitative Auditory Research
Study Officials
- PRINCIPAL INVESTIGATOR
M. Samantha Lewis, PhD
VA Portland Health Care System, Portland, OR
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 23, 2013
First Posted
May 1, 2013
Study Start
November 1, 2013
Primary Completion
March 1, 2015
Study Completion
March 1, 2015
Last Updated
October 7, 2016
Results First Posted
October 7, 2016
Record last verified: 2016-10
Data Sharing
- IPD Sharing
- Will not share