Hearing Aids, Counseling and the Significant Other

Hearing Loss Clinical Trial

Official title:

Auditory Rehabilitation From the Perspective of the Significant Other

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01809496
• Other study ID #: C7067W
• Status: Terminated
• Phase: N/A
• First received: March 6, 2013
• Last updated: December 8, 2014
• Start date: March 2013
• Est. completion date: October 2013

Study information

• Verified date: December 2014
• Source: VA National Center for Rehabilitative Auditory Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Deafness
• Hearing Loss

Intervention

Behavioral:
• Informational Counseling

• Patient Centered Counseling

Locations

Country	Name	City	State
United States	Portland VA Medical Center	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
VA National Center for Rehabilitative Auditory Research	VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

Katz S, Downs TD, Cash HR, Grotz RC. Progress in development of the index of ADL. Gerontologist. 1970 Spring;10(1):20-30. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	self-efficacy	questionnaires	4-6 weeks after the hearing aid fitting	No
Other	hearing aid use	datalogging	4-6 weeks after the hearing aid fitting	No
Primary	post-use subjective opinions regarding the hearing aids	questionnaires	4-6 weeks after the hearing aid fitting	No
Secondary	pre-use hearing aid expectations	questionnaire	immediately after the intervention at Visit #2 (Day 0)	No