Clinical trial NCT01809496: Hearing Aids, Counseling and the Significant Other
Official title: Auditory Rehabilitation From the Perspective of the Significant Other
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hearing Loss
Keywords: hearing loss
hearing aids
spouses
rehabilitation
Lead sponsor: VA National Center for Rehabilitative Auditory Research
Sponsor class: FED
Collaborators: name: US Department of Veterans Affairs
First posted: 2013-03-12
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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:

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.

Primary outcomes:
measure: post-use subjective opinions regarding the hearing aids
timeFrame: 4-6 weeks after the hearing aid fitting
Secondary outcomes:
measure: pre-use hearing aid expectations
timeFrame: immediately after the intervention at Visit #2 (Day 0)
Other outcomes:
measure: self-efficacy
timeFrame: 4-6 weeks after the hearing aid fitting
measure: hearing aid use
timeFrame: 4-6 weeks after the hearing aid fitting
Locations:
city: Portland
country: United States
facility: Portland VA Medical Center
state: Oregon
Study officials:
affiliation: VA National Center for Rehabilitative Auditory Research
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: 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.