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| Sponsor: | Department of Veterans Affairs |
|---|---|
| Information provided by: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00105742 |
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hard of Hearing |
Procedure: Diagnosis |
Phase II |
| Study Type: | Interventional |
| Study Design: | Diagnostic, Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy Study |
| Official Title: | Audiology Visits After Screening for Hearing Loss: An RCT |
| Estimated Enrollment: | 1400 |
| Study Completion Date: | June 2005 |
| Arms | Assigned Interventions |
|---|---|
| 1 | Procedure: Diagnosis |
Background:
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.
Objectives:
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.
Methods:
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, were 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 were collected. The study is not powered to determine cost-effectiveness, but to 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.
Status:
Enrollment and follow-up is complete. Outcomes data are currently being analyzed.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Hearing impaired
Exclusion Criteria:
Not Hearing Impaired
Contacts and Locations| United States, Washington | |
| VA Health Services Research and Development | |
| Seattle, Washington, United States, 98101 | |
| Principal Investigator: | Bevan Yueh, MD MPH | Department of Veterans Affairs |
More Information
| Responsible Party: | Department of Veterans Affairs ( Yueh, Bevan - Principal Investigator ) |
| Study ID Numbers: | IIR 99-377 |
| Study First Received: | March 16, 2005 |
| Last Updated: | August 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00105742 History of Changes |
| Health Authority: | United States: Federal Government |
|
Signs and Symptoms Sensation Disorders Hearing Disorders Deafness Otorhinolaryngologic Diseases |
Nervous System Diseases Neurologic Manifestations Hearing Loss Ear Diseases |