Clinical trial NCT01843777: Applying the Use of Motivational Tools to Auditory Rehabilitation
Official title: Applying the Use of Motivational Tools to Auditory Rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Keywords: hearing loss
hearing aids
motivational interviewing
counseling
rehabilitation
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2013-05-01
Enrollment: 25
Sex: ALL
Minimum age (years): 20
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Difference in Hours of Hearing Aid Use Between Pre-intervention and Post-intervention
timeFrame: Collected pre-intervention and again at post-intervention appointment occurring between four and six weeks after the intervention date
Secondary outcomes:
measure: Difference Between Pre-intervention and Post-intervention Total Score on International Outcome Inventory for Hearing Aids
timeFrame: Collected twice once at pre-intervention visit and once at a post-intervention visit occurring four to six weeks following the intervention
Other outcomes:
Locations:
city: Portland
country: United States
facility: VA Portland Health Care System, Portland, OR
state: Oregon
Study officials:
affiliation: VA Portland Health Care System, Portland, OR
name: M. Samantha Lewis, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.