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: February 6, 2014
Last verified: February 2014

November 29, 2005
February 6, 2014
February 2006
October 2007   (final data collection date for primary outcome measure)
Hearing-related quality of life, hearing aid adherence [ Designated as safety issue: No ]
Hearing-related quality of life, hearing aid adherence
Complete list of historical versions of study NCT00260663 on ClinicalTrials.gov Archive Site
Satisfaction, costs, utilization [ Designated as safety issue: No ]
Satisfaction, costs, utilization
Not Provided
Not Provided
 
The Hearing Aid Effectiveness After Aural Rehabilitation (HEAR) Trial
The Hearing Aid Effectiveness After Aural Rehabilitation (HEAR) Trial

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Hearing Loss
  • Procedure: Group hearing aid fittings
  • Procedure: Group hearing aid follow-up
Arm 1
Interventions:
  • Procedure: Group hearing aid fittings
  • Procedure: Group hearing aid follow-up

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
660
June 2008
October 2007   (final data collection date for primary outcome measure)

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

Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00260663
SLI 04-265
No
Department of Veterans Affairs
Department of Veterans Affairs
University of Washington
Principal Investigator: Margaret P. Collins, PhD MS VA Puget Sound Health Care System, Seattle
Department of Veterans Affairs
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP