Viewing Study NCT00037986



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Study NCT ID: NCT00037986
Status: COMPLETED
Last Update Posted: 2009-02-11
First Post: 2002-05-24

Brief Title: Functioning Disability and Quality of Life in the Adult Hearing Impaired
Sponsor: US Department of Veterans Affairs
Organization: VA Office of Research and Development

Study Overview

Official Title: Functioning Disability and Quality of Life in the Adult Hearing Impaired
Status: COMPLETED
Status Verified Date: 2009-02
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: The short-term research objectives of the proposed study are as follows

1 To measure the effects of audiological intervention on selected domain specific ie 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 ie 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-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 eg mental health cardiology pulmonary orthopedic etc
Detailed Description: Specific Objectives with Projected Timetable

1 Short-term objectives

1 To measure the effects of audiological intervention on selected domain specific ie 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 ie 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 eg mental health cardiology pulmonary orthopedic etc

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