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Clinical Trials/NCT01809496
NCT01809496
Terminated
Not Applicable

Auditory Rehabilitation From the Perspective of the Significant Other

VA National Center for Rehabilitative Auditory Research1 site in 1 country10 target enrollmentMarch 2013
ConditionsHearing Loss

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hearing Loss
Sponsor
VA National Center for Rehabilitative Auditory Research
Enrollment
10
Locations
1
Primary Endpoint
post-use subjective opinions regarding the hearing aids
Status
Terminated
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2013
End Date
October 2013
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
VA National Center for Rehabilitative Auditory Research
Responsible Party
Principal Investigator
Principal Investigator

M. Samantha Lewis, Ph.D.

Principal Investigator

VA National Center for Rehabilitative Auditory Research

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:
  • Age 20-85 years;
  • Intact mental status as assessed by the Mini-Mental State Examination (MMSE; Folstein, Folstein \& McHugh, 1975);
  • 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);
  • Able to read and respond to English; and
  • 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.

Outcomes

Primary Outcomes

post-use subjective opinions regarding the hearing aids

Time Frame: 4-6 weeks after the hearing aid fitting

questionnaires

Secondary Outcomes

  • pre-use hearing aid expectations(immediately after the intervention at Visit #2 (Day 0))

Study Sites (1)

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