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CompletedNCT00323427Updated Mar 6, 2014Results posted

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

A Phase 2 interventional study of The Living Well with Hearing Loss Workshop and hearing aid services in Hearing Loss and Stress, sponsored by US Department of Veterans Affairs. Completed at 2 sites in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2014-03-06.

Sponsored by US Department of Veterans Affairs · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
135
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Hearing Loss
  • Stress

Keywords

  • Audiology
  • Coping behaviors
  • Counseling
  • Hearing aids
  • Hearing impairment
  • Patient-centered care
  • Psychological adaptation
  • Psychological adjustment
  • Rehabilitation
  • Social adjustment
  • Aural Rehabilitation
03

In context

Hearing Loss

1,092 studies on the registry are indexed under Hearing Loss; 235 are open to participants now.

This study's enrollment of 135 is above the median of 40 across 764 interventional studies indexed under Hearing Loss.

Browse Hearing Loss studies →

Lead sponsor

US Department of Veterans Affairs is the lead sponsor of 658 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
135 participants (actual)

Study arms

  • Experimental
    Arm 1

    Group Aural Rehabilitation session, two hours in length, approximately 6 participants plus Group Facilitator

    Behavioral: The Living Well with Hearing Loss Workshop · Device: hearing aid services

  • Active comparator
    Arm 2

    Veterans receive new VA issued digital hearing aids per Standard VA Audiology Hearing Aid services

    Device: hearing aid services

Interventions

  • BehavioralThe 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

  • Devicehearing aid services

    Standard VA audiological hearing aid dispensing services

06

What researchers measure

Primary outcomes

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 8-weeks post-baseline relative to baseline

07

Results

Posted Mar 6, 2014

Participant flow

Participant flow — Overall Study
MilestoneGroup Aural RehabilitationHearing Aids
Started6966
Completed3843
Not completed3123

Outcome measures

PrimaryCommunication 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.

Time frame:
8 weeks post-baseline relative to baseline
Reported as:
Mean · score on a scale
Communication Profile for Hearing Impaired: Maladaptive Strategies Subscale
score on a scaleArm 1Arm 2
Communication Profile for Hearing Impaired: Maladaptive Strategies Subscale0.33 ± 0.530.37 ± 0.51
Statistical analysis
  • Arm 1 vs Arm 2 · t-test, 2 sided · p = 0.69 (No multiple testing adjustment.) · Mean difference (final values): 0.039 · 95% CI -0.15 to 0.23
PrimaryCommunication 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.

Time frame:
8 weeks post-baseline relative to baseline
Reported as:
Mean · score on a scale
Communication Profile for Hearing Impaired: Verbal Strategies Subscale
score on a scaleArm 1Arm 2
Communication Profile for Hearing Impaired: Verbal Strategies Subscale-0.34 ± 0.79-0.23 ± 0.67
Statistical analysis
  • Arm 1 vs Arm 2 · t-test, 2 sided · p = 0.42 (No adjustment.) · Mean difference (final values): 0.11 · 95% CI -0.16 to 0.38
PrimaryCommunication 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.

Time frame:
8-weeks post-baseline relative to baseline
Reported as:
Mean · score on a scale.
Communication Profile for Hearing Impaired : Non-verbal Strategies Subscale
score on a scale.Arm 1Arm 2
Communication Profile for Hearing Impaired : Non-verbal Strategies Subscale-0.22 ± 0.78-0.22 ± 0.83
Statistical analysis
  • Arm 1 vs Arm 2 · t-test, 2 sided · p = 0.97 (No adjustment) · Mean difference (final values): -0.004 · 95% CI -0.30 to 0.29

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Arm 1—0/69 (0%)0/69 (0%)
Arm 2—0/66 (0%)0/66 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Arm 1Arm 2Total
<=18 years000
Between 18 and 65 years332053
>=65 years364682
Age, Continuous
Age, Continuous(years)Arm 1Arm 2Total
Mean67.0 ± 9.871.1 ± 8.469.0 ± 9.3
Sex: Female, Male
Sex: Female, Male(Participants)Arm 1Arm 2Total
Female011
Male6965134
Region of Enrollment
Region of Enrollment(participants)Arm 1Arm 2Total
United States6966135
08

Study locations

2 sites
  • VA Medical Center, Bay Pines
    Bay Pines, Florida 33708, United States
  • VA Medical Center, Portland
    Portland, Oregon 97201, United States
09

References and documents

Related links

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 6, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00323427
Lead sponsor
US Department of Veterans Affairs
Responsible party
Sponsor
First posted
May 9, 2006
Start date
May 2007
Primary completion
Feb 2009
Completion
Sep 2010
Results posted
Mar 6, 2014
Last update
Mar 6, 2014

Study contacts

Mitchel B Turbin
principal investigator · VA Medical Center, Portland

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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