Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Clinical Trial of the "Living Well With Hearing Loss Workshop"
This study is currently recruiting participants.
Verified by Department of Veterans Affairs, August 2008
Sponsored by: Department of Veterans Affairs
Information provided by: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00323427
  Purpose

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.


Condition Intervention Phase
Hearing Loss
Stress
Behavioral: The Living Well with Hearing Loss Workshop
Device: hearing aid services
Phase II

Genetics Home Reference related topics: nonsyndromic deafness
MedlinePlus related topics: Hearing Disorders and Deafness Rehabilitation
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: Clinical Trial of the "Living Well With Hearing Loss Workshop"

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Communication Profile for the Hearing Impaired [ Time Frame: Baseline, 8 weeks re-test, and 6 months post-test ] [ Designated as safety issue: No ]

Estimated Enrollment: 180
Study Start Date: May 2007
Estimated Study Completion Date: March 2009
Estimated Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Group Aural Rehabilitation session, two hours in length, approximately 6 participants plus Group Facilitator
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
2: No Intervention
Standard VA Audiology Hearing Aid services
Device: hearing aid services
Standard VA audiological hearing aid dispensing services

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00323427

Contacts
Contact: Mitchel B Turbin (503) 220-8262 ext 56651 mitchel.turbin@va.gov
Contact: Patrick T Tsukuda, MA (503) 220-8262 ext 55747 patrick.tsukuda@va.gov

Locations
United States, Florida
VA Medical Center, Bay Pines Recruiting
Bay Pines, Florida, United States, 33708
Contact: Ramon Lopez, MD     727-398-6661     ramon.lopez@va.gov    
United States, Oregon
VA Medical Center, Portland Recruiting
Portland, Oregon, United States, 97201
Contact: Mitchel B Turbin     503-220-8262 ext 56651     mitchel.turbin@va.gov    
Contact: Bonnie Becker     (503) 220-8262 ext 54525     Bonnie.Becker@va.gov    
Principal Investigator: Mitchel B Turbin            
Sponsors and Collaborators
Investigators
Principal Investigator: Mitchel B Turbin VA Medical Center, Portland
  More Information

Study site URL  This link exits the ClinicalTrials.gov site

Responsible Party: Department of Veterans Affairs ( Turbin, Mitchel - Principal Investigator )
Study ID Numbers: C4185R
Study First Received: May 5, 2006
Last Updated: August 14, 2008
ClinicalTrials.gov Identifier: NCT00323427  
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Audiology
Coping behaviors
Counseling
Hearing aids
Hearing impairment
Patient-centered care
Psychological adaptation
Psychological adjusttment
Rehabilitation
Social adjustment

Study placed in the following topic categories:
Signs and Symptoms
Sensation Disorders
Hearing Disorders
Deafness
Otorhinolaryngologic Diseases
Retrocochlear Diseases
Neurologic Manifestations
Stress
Hearing Loss
Ear Diseases

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on January 14, 2009