Expired Study
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Bay Pines, Florida 33708


Purpose:

The short-term research objectives of the proposed study are as follows: 1. To measure the effects of audiological intervention on selected domain specific (i.e., Communicative, Interpersonal, and Social roles) and overall functioning using the WHO-DASII, a generic health measure conceptually grounded in the ICIDH-2 model of disablement and functioning. 2. To measure the effects of audiological intervention on selected domain specific (i.e., Role Functioning-Emotional; and, Social Functioning) and overall functioning using the MOS-SF36V, a generic health measure currently utilized in the Veteran's Health Administration. 3. To determine the accuracy with which measures of audibility (SII), hearing handicap (HHIE), and, hearing disability (APHAB) predict domain specific and overall functioning, and life-satisfaction as measured by the WHO-DASII and the MOS-SF36V will be evaluated. 4. To compare hearing aid treatment effects as measured by changes in WHO-DASII domain specific and overall functioning scores to those measured by changes in disease specific instruments examining similar constructs. 5. To compare hearing aid treatment effects as measured by changes in MOS-SF36V domain specific and overall functioning scores to those measured by changes in disease specific instruments examining similar constructs. 6. To determine and compare cost-effectiveness of hearing aid intervention as calculated using WHO-DASII and MOS SF-36V outcome data. The long-term research objective is to compare the cost-effectiveness and cost-utility of audiologic intervention with those of other health care interventions commonly associated with the veteran population (e.g. mental health, cardiology, pulmonary, orthopedic, etc.).


Study summary:

Specific Objectives with Projected Timetable: 1. . Short-term objectives: 1. . To measure the effects of audiological intervention on selected domain specific (i.e., Communicative, Interpersonal, and Social roles) and overall functioning using the WHO-DAS II, a generic health measure conceptually grounded in the International Classification of Impairment, Disability, and Handicap (ICIDH)-2 model of disablement and functioning (WHO, 1999). 2. . To measure the effects of audiological intervention on selected category specific (i.e., Role Functioning-Emotional and Social Functioning) and overall functioning using the MOS-SF36V, a generic health measure currently utilized in the Veterans Health Administration. 3. . To determine the accuracy with which measures of audibility (SII), hearing handicap (HHIE), and, hearing disability (APHAB) predict domain specific and overall functioning, and life-satisfaction as measured by the WHO-DAS II and the MOS-SF36V will be evaluated. 4. . To compare hearing aid treatment effects as measured by changes in WHO-DAS II domain specific and overall functioning scores to those measured by changes in disease specific instruments examining similar constructs. 5. . To compare hearing aid treatment effects as measured by changes in MOS-SF36V domain specific and overall functioning scores to those measured by changes in disease specific instruments examining similar constructs. 6. . To determine and compare cost-effectiveness of hearing aid intervention as calculated using WHO-DAS II and MOS-SF36V outcome data. 2. . Long-term objective: To compare the cost-effectiveness and cost-utility of audiologic intervention with those of other health care interventions commonly associated with the veteran population (e.g. mental health, cardiology, pulmonary, orthopedic, etc.).


Criteria:

Inclusion Criteria: Hearing impaired Exclusion Criteria:


Study is Available At:


Original ID:

C2439R


NCT ID:

NCT00037986


Secondary ID:


Study Acronym:


Brief Title:

Functioning, Disability, and Quality of Life in the Adult Hearing Impaired


Official Title:

Functioning, Disability, and Quality of Life in the Adult Hearing Impaired


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Department of Veterans Affairs


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

330


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Harvey Abrams, PhD
Principal Investigator
VA Medical Center, Bay Pines

Study Dates

Start Date:July 2001
Completion Date:June 2004
Completion Type:Actual
Primary Completion Date:May 2004
Primary Completion Type:Actual
Verification Date:February 2009
Last Changed Date:February 9, 2009
First Received Date:May 24, 2002

Study Outcomes

Outcome Type:Primary Outcome
Measure:WHO-DAS II
Time Frame:2, 6, and 12 months post intervention
Safety Issues:False

Study Interventions

Intervention Type:Device
Name:Hearing Aids
Description:Hearing aid use
Arm Name:1

Study Arms

Study Arm Type:Other
Arm Name:1

Study Agencies

Agency Class:U.S. Fed
Agency Type:Lead Sponsor
Agency Name:Department of Veterans Affairs

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
Citation:Chisolm TH, Abrams HB, McArdle R, Wilson RH, Doyle PJ. The WHO-DAS II: psychometric properties in the measurement of functional health status in adults with acquired hearing loss. Trends Amplif. 2005;9(3):111-26.
PMID:16244758
Reference Type:Results Reference
Citation:McArdle R, Chisolm TH, Abrams HB, Wilson RH, Doyle PJ. The WHO-DAS II: measuring outcomes of hearing aid intervention for adults. Trends Amplif. 2005;9(3):127-43. Erratum in: Trends Amplif. 2006;10(2):105.
PMID:16244759
Reference Type:Results Reference
Citation:Abrams HB, Chisolm TH, McArdle R. Health-related quality of life and hearing aids: a tutorial. Trends Amplif. 2005;9(3):99-109. Review.
PMID:16244757

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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