Clinical Trial of the "Living Well With Hearing Loss Workshop"

Stress Clinical Trial

Official title:

Clinical Trial of the "Living Well With Hearing Loss Workshop"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00323427
• Other study ID #: C4185-R
• Status: Completed
• Phase: Phase 2
• First received: May 5, 2006
• Last updated: January 17, 2014
• Start date: May 2007
• Est. completion date: September 2010

Study information

• 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

Clinical Trial Summary

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.

Description:

Hearing aids are essential to the rehabilitation of veterans who have acquired hearing loss. However, as with most prosthetic devices, the use of hearing aids does not result in fully normal functioning, and research shows that residual handicapping effects of hearing loss recur for many veterans. Hearing loss now affects 31 million Americans and is increasing in prevalence due to the "graying of America" and the noise-traumas of modern life, including modern warfare. VA spent over $119,000,000 on hearing aid technology for eligible veterans in FY 2004.Therefore, evidence-based rehabilitation treatments to alleviate avoidable hearing handicaps is a priority for VA and non-VA audiology. VA audiology clinics, however, are forced by high work loads to follow tight schedules for fitting hearing aids, with little time available to counsel veterans on skills for dealing effectively with the auditory and psychosocial challenges specific to their personal life style.

The proposed study will present and evaluate a single session, two hour long rehabilitation treatment model, "The Living Well with Hearing Loss Workshop." This cost-effective group intervention draws from research in psychology and behavioral medicine, as well as audiology, to teach specific skills that empower veterans to self-manage the adverse consequences of their hearing loss. The workshops will use multi-media presentations to train participating veterans in cognitive, behavioral and affective coping skills, while the patient-centered process focuses on collaborative problem-solving of hearing-loss-challenges participants present to their groups as personally important.

This is a dual site, randomized clinical trial, conducted by Co-PIs Dr. Turbin, a psychologist and Investigator at the NCRAR in the Portland, Oregon VAMC; and Dr. Abrams, a rehabilitative audiologist and Chief of Audiology Services at the Bay Pines, Florida VAMC. We will recruit a total of 310 veterans, all patients at the VAMC audiology clinics in Portland or Bay Pines, who are: 1) recipients of their first hearing aids, 2) have a mild to moderately-severe hearing loss in their better ear, and 3) present no other condition that would preclude their participation in age-appropriate interpersonal activities. Half of these veterans will be randomized to each of our two treatments: the Control condition of routine VA hearing-aid-rehabilitation-alone, and our Experimental Treatment condition of routine audiology services plus our workshop intervention. All subjects will complete three questionnaires as Pre-test measures before hearing aid fitting, eight weeks after hearing aid fitting as Re-tests and then four months later as Post-tests. An additional personality inventory will be administered only at baseline, yielding co-variates for interpreting possible within-group variance. Workshop participants will attend their session within one month of hearing aid fitting. The workshops will be facilitated by audiologists we will train in our empowering, patient-centered, coping-skills based model.

We hypothesize that our Workshop participants will show enhanced personal adjustment and use of communication strategies when compared to both baseline and to Control subjects, and further hypothesize that our Workshop participants will exceed our Controls in self reported hearing aid benefit at Re-test, and retain these differential treatment benefits at Post-test. The outcome data will enhance our understanding about the coping processes by which people respond to their hearing disability and its treatment by hearing-aids-alone, and about how well Workshop participants learn and utilize the skills taught in our treatment model. The findings from this research can foster continued development and implementation of evidence-based rehabilitation treatments and, if shown to be effective, our model can be replicated at audiology clinics, adapted for video or online training, or used by other health care professionals or even lay mentors to enhance the quality of life of people who are hard of hearing.

Recruitment information / eligibility

• 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.

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
• Stress

Intervention

Behavioral:
• The Living Well with Hearing Loss Workshop
Interactive group session modeled on Patient-Centered medicine and Adult Learning principles; the participants are partners with the Group Facilitator who is a hearing rehabilitation professional

Device:
• hearing aid services
Standard VA audiological hearing aid dispensing services

Locations

Country	Name	City	State
United States	VA Medical Center, Bay Pines	Bay Pines	Florida
United States	VA Medical Center, Portland	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

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

External Links

•   Study site URL