Study Stopped
Funding ended
Hearing Aids, Counseling and the Significant Other
Auditory Rehabilitation From the Perspective of the Significant Other
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2013
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
March 6, 2013
CompletedFirst Posted
Study publicly available on registry
March 12, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedDecember 9, 2014
December 1, 2014
7 months
March 6, 2013
December 8, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
post-use subjective opinions regarding the hearing aids
questionnaires
4-6 weeks after the hearing aid fitting
Secondary Outcomes (1)
pre-use hearing aid expectations
immediately after the intervention at Visit #2 (Day 0)
Other Outcomes (2)
self-efficacy
4-6 weeks after the hearing aid fitting
hearing aid use
4-6 weeks after the hearing aid fitting
Study Arms (4)
Informational counseling, patient only
ACTIVE COMPARATORThe purpose of this experimental group is to evaluate the effectiveness of informational counseling alone. This type of counseling is considered the standard of care in audiologic practice. Patients in this will review this material in detail with a member of the study team for approximately 30 minutes at the second visit. Spouses in this experimental group will be will review material regarding VA services with a member of the study team for about 30 minutes.
Informational Counseling, couples
EXPERIMENTALThe purpose of this experimental group is to evaluate the influence of spousal involvement when receiving informational counseling. In this manner, both patients and spouses are presented with the same information regarding hearing loss and hearing aids. Couples in this experimental group will be given the same information that the patients in the first group were given. At the second visit, couples in this group will review this information together with a member of the research team for approximately 30 minutes.
Patient Centered Counseling,patient only
EXPERIMENTALIn order to assess the effects of enhanced patient-centered counseling (PCC), the patients assigned to this group will meet together with either Dr. Lewis or the Research Audiologist for approximately 30 minutes of counseling. In addition to the PCC techniques used in audiology, this counseling also will involve the core components of motivational interviewing. These principles and methods will be used to allow the patient to clearly express his/her expectations of, concerns about, and motivations for hearing-aid use. The spouses in this experimental group will be given information regarding VA services. This material will be reviewed with a member of the research team for about 30 minutes at the second visit.
Patient Centered Counseling, couples
EXPERIMENTALIn order to assess the influence of the spouse on the enhanced PCC process, the couples assigned to this group will meet together with either Dr. Lewis or the Research Audiologist for approximately 30 minutes of counseling. This counseling will be conducted with both the patient and the spouse together, giving both partners time to express their thoughts.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Portland VA Medical Center
Portland, Oregon, 97207, United States
Related Publications (2)
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.
PMID: 5420677BACKGROUNDFolstein 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.
PMID: 1202204BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
M. Samantha Lewis, PhD
VA National Center for Rehabilitative Auditory Research
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 6, 2013
First Posted
March 12, 2013
Study Start
March 1, 2013
Primary Completion
October 1, 2013
Study Completion
October 1, 2013
Last Updated
December 9, 2014
Record last verified: 2014-12