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OpenTrials
Completed

NCT Number: NCT00105742

Audiology Visits After Screening for Hearing Loss: An RCT

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Seattle, Washington, 98108, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Hearing impaired

Exclusion criteria

Not Hearing Impaired

Treatment and study plan

Diagnosis

Procedure

Primary outcomes

  1. Better diagnois of hearing problems

Secondary outcomes

  1. Improved quality of life

Sponsors and collaborators

Lead sponsor

US Department of Veterans Affairs

Fed

Registry information

Important dates

Study completion
2005
First posted
Mar 17, 2005
Registry last updated
Apr 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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