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.
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
- Type of treatment
- Medical device, Lifestyle or therapy programme
- 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
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 group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Group 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 2 | Active comparator | Veterans 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.
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
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
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.
- First posted9 May 2006 (estimated)
- Study startMay 2007
- Primary completionFeb 2009
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Mitchel B Turbin, Principal investigator, VA Medical Center, Portland
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
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of the "Living Well With Hearing Loss Workshop"
- ClinicalTrials.gov ID
- NCT00323427
- Acronym / sponsor ID
- C4185-R
- Conditions
- Hearing Loss, Stress
- Keywords
- Audiology, Coping behaviors, Counseling, Hearing aids, Hearing impairment, Patient-centered care, Psychological adaptation, Psychological adjustment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- May 2007
- Primary completion
- Feb 2009 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 9 May 2006 (estimated)
- Results
- Posted 6 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 $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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Behavioral: The Living Well with Hearing Loss Workshop, Device: hearing aid servicesGroup Aural Rehabilitation session, two hours in length, approximately 6 participants plus Group Facilitator |
| Arm 2 | Active comparator | Device: hearing aid servicesVeterans receive new VA issued digital hearing aids per Standard VA Audiology Hearing Aid services |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects are users of new hearing aids with mild to severe hearing loss in better ear.
Key exclusion criteria (1 listed)
- Patient has been in aural rehabilitation in the past 2 years, or has a condition besides hearing loss that affects age-appropriate social activity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Living Well with Hearing Loss WorkshopInteractive 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 | Behavioural | Arm 1 |
| hearing aid servicesStandard VA audiological hearing aid dispensing services | Device | Arm 1, Arm 2 |
Primary outcome
Communication Profile for Hearing Impaired: Maladaptive Strategies Subscale
Time frame: 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.
Communication Profile for Hearing Impaired: Verbal Strategies Subscale
Time frame: 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.
Communication Profile for Hearing Impaired : Non-verbal Strategies Subscale
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Study site URLLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mitchel B Turbin principal investigator
VA Medical Center, Portland
2 sites in 1 country: see every site and its status.
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.