Audiology Visits After Screening for Hearing Loss: An RCT
Tracking Information | |||||
---|---|---|---|---|---|
First Received Date ICMJE | March 16, 2005 | ||||
Last Updated Date | August 1, 2012 | ||||
Start Date ICMJE | |||||
Primary Completion Date | |||||
Current Primary Outcome Measures ICMJE |
Better diagnois of hearing problems [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures ICMJE |
Better diagnois of hearing problems | ||||
Change History | Complete list of historical versions of study NCT00105742 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
Improved quality of life [ Designated as safety issue: No ] | ||||
Original Secondary Outcome Measures ICMJE |
Improved quality of life | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Audiology Visits After Screening for Hearing Loss: An RCT | ||||
Official Title ICMJE | Audiology Visits After Screening for Hearing Loss: An RCT | ||||
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. |
||||
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 ICMJE | Interventional | ||||
Study Phase | Phase 2 | ||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
||||
Condition ICMJE | Hard of Hearing | ||||
Intervention ICMJE | Procedure: Diagnosis | ||||
Study Arm (s) | Arm 1
Intervention: Procedure: Diagnosis |
||||
Publications * |
|
||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Estimated Enrollment ICMJE | 1400 | ||||
Completion Date | June 2005 | ||||
Primary Completion Date | |||||
Eligibility Criteria ICMJE | Inclusion Criteria: Hearing impaired Exclusion Criteria: Not Hearing Impaired |
||||
Gender | Both | ||||
Ages | |||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00105742 | ||||
Other Study ID Numbers ICMJE | IIR 99-377 | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | Department of Veterans Affairs | ||||
Study Sponsor ICMJE | Department of Veterans Affairs | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
|
||||
Information Provided By | Department of Veterans Affairs | ||||
Verification Date | July 2006 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |