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

17 gennaio 2014 aggiornato da: US Department of Veterans Affairs
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.

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

135

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • Florida
      • Bay Pines, Florida, Stati Uniti, 33708
        • VA Medical Center, Bay Pines
    • Oregon
      • Portland, Oregon, Stati Uniti, 97201
        • VA Medical Center, Portland

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 85 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Arm 1
Group Aural Rehabilitation session, two hours in length, approximately 6 participants plus Group Facilitator
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
Standard VA audiological hearing aid dispensing services
Comparatore attivo: Arm 2
Veterans receive new VA issued digital hearing aids per Standard VA Audiology Hearing Aid services
Standard VA audiological hearing aid dispensing services

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Communication Profile for Hearing Impaired: Maladaptive Strategies Subscale
Lasso di tempo: 8 weeks post-baseline relative to baseline

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
Communication Profile for Hearing Impaired: Verbal Strategies Subscale
Lasso di tempo: 8 weeks post-baseline relative to baseline

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
Communication Profile for Hearing Impaired : Non-verbal Strategies Subscale
Lasso di tempo: 8-weeks post-baseline relative to baseline

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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Mitchel B Turbin, VA Medical Center, Portland

Pubblicazioni e link utili

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Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 maggio 2007

Completamento primario (Effettivo)

1 febbraio 2009

Completamento dello studio (Effettivo)

1 settembre 2010

Date di iscrizione allo studio

Primo inviato

5 maggio 2006

Primo inviato che soddisfa i criteri di controllo qualità

5 maggio 2006

Primo Inserito (Stima)

9 maggio 2006

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

6 marzo 2014

Ultimo aggiornamento inviato che soddisfa i criteri QC

17 gennaio 2014

Ultimo verificato

1 gennaio 2014

Maggiori informazioni

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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