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Audiology Visits After Screening for Hearing Loss: An RCT

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ClinicalTrials.gov Identifier: NCT00105742
Recruitment Status : Completed
First Posted : March 17, 2005
Last Update Posted : April 7, 2015
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
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 or disease Intervention/treatment Phase
Hard of Hearing Procedure: Diagnosis Phase 2

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1400 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Audiology Visits After Screening for Hearing Loss: An RCT
Study Completion Date : June 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Arm 1 Procedure: Diagnosis



Primary Outcome Measures :
  1. Better diagnois of hearing problems

Secondary Outcome Measures :
  1. Improved quality of life


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Hearing impaired

Exclusion Criteria:

Not Hearing Impaired


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00105742


Locations
United States, Washington
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, United States, 98108
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Bevan Yueh, MD MPH VA Puget Sound Health Care System Seattle Division, Seattle, WA

Publications:
Collins MP, Souza PE, Yueh B. Effects of group versus individual hearing aid visits. Journal of The American Auditory Society. 2007 Mar 1; 31(1):34.
Yueh B, Collins MP, Souza PE. Effects of depression on self-report hearing outcomes. Journal of The American Auditory Society. 2007 Mar 1; 32(1):32.

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00105742     History of Changes
Other Study ID Numbers: IIR 99-377
First Posted: March 17, 2005    Key Record Dates
Last Update Posted: April 7, 2015
Last Verified: July 2006

Additional relevant MeSH terms:
Hearing Loss
Deafness
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms