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Deafness & Hearing Loss |
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Clinical Trial: Functioning, Disability, and Quality of Life in the Adult Hearing Impaired
This study is currently recruiting patients.
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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.).
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Hearing impaired | Procedure: Hearing | Phase II |
MedlinePlus related topics: Hearing Disorders and Deafness
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Expected Total Enrollment: 330
Study start: July 2001; Expected completion: June 2004
Specific Objectives with Projected Timetable:
(1). Short-term objectives:
(a). 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).
(b). 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.
(c). 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.
(d). 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.
(e). 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.
(f). 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.).
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
Location and Contact Information
Florida
VA Medical Center, Bay Pines, Florida, United States; Recruiting
Harvey Abrams, Ph.D., Principal Investigator
David Wolff, Ph.D. Special Assistant to the Director, Program Analysis and Review Section (PARS), VA Rehabilitation Research & Development Service
More Information
Record last reviewed: May 2002
Last Updated: October 13, 2004
Record first received: May 24, 2002
ClinicalTrials.gov Identifier: NCT00037986
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- (National Women's Health Information Center, OWH, HHS)
- 1999 Federal Government TTY Directory (Federal Citizen Information Center, GSA)

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