The Hearing Aid Effectiveness After Aural Rehabilitation (HEAR) Trial

This study has been completed.
Sponsor:
Collaborator:
University of Washington
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00260663
First received: November 29, 2005
Last updated: April 16, 2014
Last verified: April 2014
  Purpose

This study compares the effectiveness of hearing aid appointments provided in a group format to those provided in an individual format. We are asking if hearing aid training with group appointments is as good as or better than with individual appointments.


Condition Intervention
Hearing Loss
Procedure: Group hearing aid fittings
Procedure: Group hearing aid follow-up

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Hearing Aid Effectiveness After Aural Rehabilitation (HEAR) Trial

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Hearing-related quality of life, hearing aid adherence [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Satisfaction, costs, utilization [ Designated as safety issue: No ]

Enrollment: 660
Study Start Date: February 2006
Study Completion Date: June 2008
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm 1 Procedure: Group hearing aid fittings Procedure: Group hearing aid follow-up

Detailed Description:

Background: The number of hearing aids dispensed by the VA has nearly quadrupled from 75,000 in 1996 to over 283,000 in 2003. However, the number of audiologists serving this population has less than doubled (72% increase) in the same period. This imbalance has resulted in burgeoning waiting times for audiology appointments, negatively impacting the quality of life of thousands of veterans while they wait for hearing aids. Reduction in waiting times through more efficient use of limited resources while maintaining high quality care is of great interest to VA leadership. Objectives: The orientation portion of the hearing aid fitting appointment and the hearing aid follow-up visit 4 The researcherseks later impart standard information relevant to all new hearing aid patients, and may be highly conducive to group format. Our specific aims are to compare group and the current standard of individual aural rehabilitation appointments to determine if: 1) group visits are at least as effective ('non-inferior') as individual visits for each audiology appointment, and 2) the use of group visits leads to lower costs for the VA. Methods: The researchers propose a non-inferiority, randomized clinical trial to compare the effectiveness of group vs. individual audiology appointments. The researchers will compare group vs. individual visits for two types of audiology appointments: hearing aid fitting (orientation only) and hearing aid follow-up. The researchers hypothesize that: 1) group visits are at least as effective as individual visits, as measured by hearing-related quality of life and hearing aid adherence, and 2) group visits lead to cost savings, not just in the immediate treatment period, but throughout a 6-month aural rehabilitation period. Setting and Population. The researchers propose to enroll 660 new hearing aid patients from the audiology clinics at the Seattle and American Lake Divisions of VA Puget Sound Health Care System. Randomized Interventions. Patients will be randomized to group vs. individual orientation (intervention #1) and group vs. individual follow-up (intervention #2) visits. Status: Recruitment is completed. The primary effectiveness outcome will be hearing-related quality of life 6 months after the hearing aid fitting. Secondary effectiveness outcomes will include hearing aid adherence and satisfaction with hearing amplification. Cost and utilization outcomes will include audiology labor for the initial visits and subsequent unplanned visits, the cost of hearing aids, and the number of hearing aid repairs. The researchers selected a time frame of 6 months because pilot data show that 75% of unplanned visits occur in the first 6 months. Analysis. An intention-to-treat analysis will be used to minimize bias due to subject self-selection. The researchers have chosen a sample size adequate to detect non-inferiority of hearing-related quality of life in patients undergoing group rehabilitation in either intervention. Analyses for each intervention will be stratified by degree of hearing loss, binaural vs. monaural hearing aid use, and group vs. individual appointment of the other intervention. Cost-effectiveness analyses will be pursued if greater effectiveness and higher costs are both documented, in which case pilot calculations of the unit cost to obtain an additional successfully treated patient (those with a clinically important improvement of 6 points on the Inner EAR scale) will be made. Benefit to VA. This proposal directly addresses three of the VA's designated research areas: sensory disorders, aging, and health services. In addition, this application is directly responsive to an HSR&D Solicitation on sensory disorders and loss. This project has the potential to help VA leadership identify more efficient treatment that maintains high quality care for one of the most common disabilities in veterans, and to provide insight into the value of group visits as a model of care.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

New hearing aid users at VA Puget Sound; eligible for VA hearing aids

Exclusion Criteria:

Prior hearing aid users; Inability to participate in a group rehabilitation sessions or to complete follow-up

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00260663

Locations
United States, Washington
VA Health Services Research and Development
Seattle, Washington, United States, 98101
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Margaret P. Collins, PhD MS VA Puget Sound Health Care System, Seattle
  More Information

Additional Information:
Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00260663     History of Changes
Other Study ID Numbers: SLI 04-265
Study First Received: November 29, 2005
Last Updated: April 16, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Hearing Impaired Rehabilitation
Hearing Aids
Randomized Controlled Trials
Cost Effectiveness
Quality of life
Patient Compliance

Additional relevant MeSH terms:
Hearing Loss
Deafness
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 31, 2014