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


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Deafness & Hearing Loss




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

This study is currently recruiting patients.

Sponsored by: Department of Veterans Affairs
Information provided by: Department of Veterans Affairs

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

Further Study Details: 

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

Hearing impaired

Location and Contact Information

Harvey Abrams      727-398-9395    harvey.abrams@med.va.gov

Florida
      VA Medical Center, Bay Pines,  Florida,  United States; Recruiting
Harvey Abrams, Ph.D.  727-398-9395    harvey.abrams@med.va.gov 
Harvey Abrams, Ph.D.,  Principal Investigator

Study chairs or principal investigators

David Wolff, Ph.D. Special Assistant to the Director,  Program Analysis and Review Section (PARS), VA Rehabilitation Research & Development Service   

More Information

Study ID Numbers:  C2439
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

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December 4, 2008



Page Updated: September 6, 2005
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