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Hearing Aids, Counseling and the Significant Other

Auditory Rehabilitation From the Perspective of the Significant Other

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01809496
Enrollment
10
Registered
2013-03-12
Start date
2013-03-31
Completion date
2013-10-31
Last updated
2014-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hearing Loss

Keywords

hearing loss, hearing aids, spouses, rehabilitation

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.

Interventions

BEHAVIORALInformational Counseling
BEHAVIORALPatient Centered Counseling

Sponsors

US Department of Veterans Affairs
CollaboratorFED
VA National Center for Rehabilitative Auditory Research
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
post-use subjective opinions regarding the hearing aids4-6 weeks after the hearing aid fittingquestionnaires

Secondary

MeasureTime frameDescription
pre-use hearing aid expectationsimmediately after the intervention at Visit #2 (Day 0)questionnaire

Other

MeasureTime frameDescription
self-efficacy4-6 weeks after the hearing aid fittingquestionnaires
hearing aid use4-6 weeks after the hearing aid fittingdatalogging

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026