Stress Clinical Trial
Official title:
Clinical Trial of the "Living Well With Hearing Loss Workshop"
Verified date | January 2014 |
Source | VA Office of Research and Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
This study evaluates whether a 2 hour group session, "The Living Well with Hearing Loss Workshop," can successfully teach hard of hearing people how to best use hearing aids and a variety of personal skills to compensate for the limitations of their impaired ears.
Status | Completed |
Enrollment | 135 |
Est. completion date | September 2010 |
Est. primary completion date | February 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 85 Years |
Eligibility |
Inclusion Criteria: - Subjects are users of new hearing aids with mild to severe hearing loss in better ear. Exclusion Criteria: - Patient has been in aural rehabilitation in the past 2 years, or has a condition besides hearing loss that affects age-appropriate social activity. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | VA Medical Center, Bay Pines | Bay Pines | Florida |
United States | VA Medical Center, Portland | Portland | Oregon |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Communication Profile for Hearing Impaired: Maladaptive Strategies Subscale | The Communication Profile for Hearing Impaired (CPHI) queries subjects on how well they can communicate with others. The Maladaptive strategies subscale describe behaviors that prevent the individual from coping effectively with communication problems. 8 week change score from baseline value. Larger values of the change score indicate less use of maladaptive behaviors. Larger group mean change score indicates BETTER performance on this scale. CPHI Maladaptive strategies subscale ranges from 1 (better) to 5 (worse) maladaptive strategy usage. |
8 weeks post-baseline relative to baseline | No |
Primary | Communication Profile for Hearing Impaired: Verbal Strategies Subscale | The Communication Profile for Hearing Impaired (CPHI) queries subjects on how well they can communicate with others. The Verbal Strategies subscale describe adaptive strategies for coping with the effects of hearing impairment on communication. 8 week change score from baseline value. Larger values of the change score indicate more use of adaptive Verbal Strategies. Larger group mean change score indicates BETTER performance on this scale. CPHI Verbal Strategies scores vary from 1 (worse) to 5 (best) strategy usage. |
8 weeks post-baseline relative to baseline | No |
Primary | Communication Profile for Hearing Impaired : Non-verbal Strategies Subscale | The Communication Profile for Hearing Impaired (CPHI) queries subjects on how well they can communicate with others. The Non-verbal Strategies subscale describe adaptive coping strategies but they describe unobtrusive, nonverbal behaviors that the individual can use to maximize communication effectiveness. 8 week change score from baseline value. Larger values of the change score indicate more use of adaptive non-verbal behaviors. Larger group mean change score indicates BETTER performance on this scale. The CPHI Non-verbal strategies score ranges from 1 (worse) to 5 (better) usage of non-verbal strategies. |
8-weeks post-baseline relative to baseline | No |
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