Audiology Visits After Screening for Hearing Loss: An RCT
Primary Purpose
Hard of Hearing
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Diagnosis
Sponsored by
About this trial
This is an interventional diagnostic trial for Hard of Hearing
Eligibility Criteria
Inclusion Criteria: Hearing impaired Exclusion Criteria: Not Hearing Impaired
Sites / Locations
- VA Puget Sound Health Care System Seattle Division, Seattle, WA
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Arm 1
Arm Description
Outcomes
Primary Outcome Measures
Better diagnois of hearing problems
Secondary Outcome Measures
Improved quality of life
Full Information
NCT ID
NCT00105742
First Posted
March 16, 2005
Last Updated
April 6, 2015
Sponsor
US Department of Veterans Affairs
1. Study Identification
Unique Protocol Identification Number
NCT00105742
Brief Title
Audiology Visits After Screening for Hearing Loss: An RCT
Official Title
Audiology Visits After Screening for Hearing Loss: An RCT
Study Type
Interventional
2. Study Status
Record Verification Date
July 2006
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hard of Hearing
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Diagnosis
Primary Outcome Measure Information:
Title
Better diagnois of hearing problems
Secondary Outcome Measure Information:
Title
Improved quality of life
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Hearing impaired
Exclusion Criteria:
Not Hearing Impaired
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bevan Yueh, MD MPH
Organizational Affiliation
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Puget Sound Health Care System Seattle Division, Seattle, WA
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States
12. IPD Sharing Statement
Citations:
Citation
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.
Results Reference
result
Citation
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.
Results Reference
result
PubMed Identifier
17030153
Citation
Yueh B, Collins MP, Souza PE, Heagerty PJ, Liu CF, Boyko EJ, Loovis CF, Fausti SA, Hedrick SC. Screening for Auditory Impairment-Which Hearing Assessment Test (SAI-WHAT): RCT design and baseline characteristics. Contemp Clin Trials. 2007 May;28(3):303-15. doi: 10.1016/j.cct.2006.08.008. Epub 2006 Aug 30.
Results Reference
result
PubMed Identifier
20398111
Citation
Yueh B, Collins MP, Souza PE, Boyko EJ, Loovis CF, Heagerty PJ, Liu CF, Hedrick SC. Long-term effectiveness of screening for hearing loss: the screening for auditory impairment--which hearing assessment test (SAI-WHAT) randomized trial. J Am Geriatr Soc. 2010 Mar;58(3):427-34. doi: 10.1111/j.1532-5415.2010.02738.x.
Results Reference
result
PubMed Identifier
12697801
Citation
Yueh B, Shapiro N, MacLean CH, Shekelle PG. Screening and management of adult hearing loss in primary care: scientific review. JAMA. 2003 Apr 16;289(15):1976-85. doi: 10.1001/jama.289.15.1976.
Results Reference
result
PubMed Identifier
12697802
Citation
Bogardus ST Jr, Yueh B, Shekelle PG. Screening and management of adult hearing loss in primary care: clinical applications. JAMA. 2003 Apr 16;289(15):1986-90. doi: 10.1001/jama.289.15.1986.
Results Reference
result
PubMed Identifier
11074842
Citation
Yueh B. Digital hearing aids. Arch Otolaryngol Head Neck Surg. 2000 Nov;126(11):1394-7. doi: 10.1001/archotol.126.11.1394. No abstract available.
Results Reference
result
PubMed Identifier
11283492
Citation
Kezirian EJ, White KR, Yueh B, Sullivan SD. Cost and cost-effectiveness of universal screening for hearing loss in newborns. Otolaryngol Head Neck Surg. 2001 Apr;124(4):359-67. doi: 10.1067/mhn.2001.113945.
Results Reference
result
PubMed Identifier
11587599
Citation
Yueh B, Souza PE, McDowell JA, Collins MP, Loovis CF, Hedrick SC, Ramsey SD, Deyo RA. Randomized trial of amplification strategies. Arch Otolaryngol Head Neck Surg. 2001 Oct;127(10):1197-204. doi: 10.1001/archotol.127.10.1197.
Results Reference
result
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Audiology Visits After Screening for Hearing Loss: An RCT
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