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Deafness & Hearing Loss |
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Clinical Trial: Audiology Visits after Screening for Hearing Loss
This study is currently recruiting patients.
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Purpose
Hearing impairment is one of the most common disabilities in veterans. The decreased ability to communicate is troubling in itself, but the strong association of hearing loss with functional decline and depression adds further to the burden on the hearing-impaired. Although hearing amplification improves quality of life, hearing evaluations are offered infrequently to older patients. Only 25 percent of patients with aidable hearing loss receive treatment. Up to 30 percent of patients who receive hearing aids do not use them. We contend that an effective formal screening program should identify hearing-impaired patients who are motivated to seek evaluation and who derive benefit from treatment.
The first specific aim is to determine if formal screening programs for hearing loss can increase visits to audiologists. The second specific aim is to determine which specific screening strategy leads to the most frequent audiology visits. Our four-armed, randomized, clinical trial compares three screening strategies (physiologic testing, a self-report questionnaire, and combined use of both physiologic and self-report testing), against a control arm (usual care). Physiologic testing was done with the Audioscope, a portable otoscope that emits tones from selected frequencies at a variety of loudness levels. The self-report questionnaire was the screening version of the Hearing Handicap Inventory of the Elderly questionnaire (HHIE-S), which quantifies the social and emotional handicap from hearing loss. Patients aged 50 and older who did not wear hearing aids were recruited from the outpatient clinics at the VA Puget Sound Health Care System. Only patients who were eligible for VA-issued hearing aids were enrolled in this trial. Patients randomized to the control arm were not screened. Patients screened with both the Audioscope and HHIE-S were referred to the audiology service for evaluation if either of the tests was positive. All patients, regardless of screening status, are being followed to determine how many patients in each arm subsequently visit an audiologist.
The primary outcome is the percentage of patients who contact the audiology service within 6 months of the date of screening. Secondary outcomes include: 1) the number of cases of hearing loss detected; 2) the number of dispensed hearing aids; 3) self-rated communication ability; 4) hearing-related quality of life; and 5) rates of hearing aid adherence. Costs of screening and subsequent treatment will be collected. The study is not powered to determine cost-effectiveness, but pilot calculations of the costs to implement the screening program will be made. An intention-to-screen analysis will be used to minimize bias due to subject self-selection.
| Condition | Phase |
|---|---|
| Hearing Impairment | Phase II |
MedlinePlus related topics: Hearing Disorders and Deafness
Study Type: Observational
Study Design: Screening, Longitudinal, Defined Population, Retrospective/Prospective Study
Official Title: Audiology Visits after Screening for Hearing Loss: An RCT
Expected Total Enrollment: 1400
Study start: October 2001; Expected completion: June 2005
Eligibility
Genders Eligible for Study: Both
Criteria
- Hearing impaired
Location and Contact Information
Washington
VA Puget Sound Health Care System, Seattle, Washington, 98109, United States; Recruiting
VA Puget Sound Health Care System, Seattle, Washington, 98109, United States; Recruiting
More Information
Record last reviewed: March 2005
Last Updated: March 16, 2005
Record first received: March 16, 2005
ClinicalTrials.gov Identifier: NCT00105742
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 8, 2005
Resources
- (National Women's Health Information Center, OWH, HHS)
- 1999 Federal Government TTY Directory (Federal Citizen Information Center, GSA)

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