Ignite Creation Date:
2024-05-05 @ 4:49 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00323427
Status:
COMPLETED
Last Update Posted:
2014-03-06
First Post:
2006-05-05
Brief Title:
Clinical Trial of the Living Well With Hearing Loss Workshop
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Clinical Trial of the Living Well With Hearing Loss Workshop
Status:
COMPLETED
Status Verified Date:
2014-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 119000000 on hearing aid technology for eligible veterans in FY 2004Therefore 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None