Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00105742
Status:
COMPLETED
Last Update Posted:
2015-04-07
First Post:
2005-03-16
Brief Title:
Audiology Visits After Screening for Hearing Loss An RCT
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Audiology Visits After Screening for Hearing Loss An RCT
Status:
COMPLETED
Status Verified Date:
2006-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None