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

NCT00323427 | Completed Phase 2 Results

• 1 other identifier: C4185-R
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Hearing Loss; Stress

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  8-weeks post-baseline relative to baseline

Study Arms (2)

Arm 1

EXPERIMENTAL

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

Arm 2

ACTIVE COMPARATOR

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

Device: hearing aid services

Interventions

The Living Well with Hearing Loss Workshop BEHAVIORAL

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

Arm 1

hearing aid services DEVICE

Standard VA audiological hearing aid dispensing services

Arm 1; Arm 2

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (2)

VA Medical Center, Bay Pines

Bay Pines, Florida, 33708, United States

Location

VA Medical Center, Portland

Portland, Oregon, 97201, United States

Location

Related Links

• Study site URL

MeSH Terms

Conditions

Hearing Loss; Social Adjustment

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Social Behavior; Behavior

Results Point of Contact

• Title: Mitchel Turbin, Ph.D.
• Organization: Portland VA Medical Center

bonnie.becker@va.gov

503-220-8262

Study Officials

• Mitchel B Turbin

  VA Medical Center, Portland

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2006
• First Posted: May 9, 2006
• Study Start: May 1, 2007
• Primary Completion: February 1, 2009
• Study Completion: September 1, 2010
• Last Updated: March 6, 2014
• Results First Posted: March 6, 2014

Record last verified: 2014-01

Locations

US (2)