Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00260663
Status:
COMPLETED
Last Update Posted:
2015-04-07
First Post:
2005-11-29
Brief Title:
The Hearing Aid Effectiveness After Aural Rehabilitation HEAR Trial
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
The Hearing Aid Effectiveness After Aural Rehabilitation HEAR Trial
Status:
COMPLETED
Status Verified Date:
2008-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
Background The number of hearing aids dispensed by the VA has nearly quadrupled from 75000 in 1996 to over 283000 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 VAs designated research areas sensory disorders aging and health services In addition this application is directly responsive to an HSRD 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None