AzTrials
AzTrials

Hearing LossPhase 2NCT00323427

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

A Phase 2 study testing The Living Well with Hearing Loss Workshop and hearing aid services in people with Hearing Loss and Stress, run by US Department of Veterans Affairs at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Hearing Loss, Stress
What is being tested?
The Living Well with Hearing Loss Workshop and hearing aid services
Could I receive a placebo?
No, everyone receives an active treatment
How many people
135 participants
Where
2 sitesUnited States
Study dates
May 2007to Sep 2010
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects are users of new hearing aids with mild to severe hearing loss in better ear.

Who cannot join

  • Patient has been in aural rehabilitation in the past 2 years, or has a condition besides hearing loss that affects age-appropriate social activity.

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • VA Medical Center, Bay Pines

    Bay Pines, Florida, 33708

  • VA Medical Center, Portland

    Portland, Oregon, 97201

Other trials in United States

About this study

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.

Read the 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.

Conditions
Hearing Loss, Stress
Being tested
The Living Well with Hearing Loss Workshop, hearing aid services
Keywords
Audiology, Coping behaviors, Counseling, Hearing aids, Hearing impairment, Patient-centered care, Psychological adaptation, Psychological adjustment, Rehabilitation, Social adjustment, Aural Rehabilitation
Medical subject headings
Hearing Loss, Social Adjustment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • The Living Well with Hearing Loss WorkshopBehavioural

    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

  • hearing aid servicesDevice

    Standard VA audiological hearing aid dispensing services

Study groups in NCT00323427
Study groupRoleWhat they receive
Arm 1ExperimentalGroup Aural Rehabilitation session, two hours in length, approximately 6 participants plus Group Facilitator
Receives: Behavioral: The Living Well with Hearing Loss Workshop; Device: hearing aid services
Arm 2Active comparatorVeterans receive new VA issued digital hearing aids per Standard VA Audiology Hearing Aid services
Receives: Device: hearing aid services

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 8 weeks post-baseline relative to baseline

  2. 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.

    Measured: 8 weeks post-baseline relative to baseline

  3. 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.

    Measured: 8-weeks post-baseline relative to baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 May 2006 (estimated)
  2. Study startMay 2007
  3. Primary completionFeb 2009
  4. Study completionSep 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
135 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00323427
Sponsor's protocol ID
C4185-R
Status last verified
Jan 2014
First submitted
5 May 2006
Last updated
6 Mar 2014
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing The Living Well with Hearing Loss Workshop and hearing aid services in people with Hearing Loss and Stress, run by US Department of Veterans Affairs at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Communication Profile for Hearing Impaired: Maladaptive Strategies Subscale (time frame: 8 weeks post-baseline relative to baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2014.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in