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

17. januar 2014 oppdatert av: 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.

Studieoversikt

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

135

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Florida
      • Bay Pines, Florida, Forente stater, 33708
        • VA Medical Center, Bay Pines
    • Oregon
      • Portland, Oregon, Forente stater, 97201
        • VA Medical Center, Portland

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 85 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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
Aktiv komparator: Arm 2
Veterans receive new VA issued digital hearing aids per Standard VA Audiology Hearing Aid services
Standard VA audiological hearing aid dispensing services

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Communication Profile for Hearing Impaired: Maladaptive Strategies Subscale
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Mitchel B Turbin, VA Medical Center, Portland

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. mai 2007

Primær fullføring (Faktiske)

1. februar 2009

Studiet fullført (Faktiske)

1. september 2010

Datoer for studieregistrering

Først innsendt

5. mai 2006

Først innsendt som oppfylte QC-kriteriene

5. mai 2006

Først lagt ut (Anslag)

9. mai 2006

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

6. mars 2014

Siste oppdatering sendt inn som oppfylte QC-kriteriene

17. januar 2014

Sist bekreftet

1. januar 2014

Mer informasjon

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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