Functioning, Disability, and Quality of Life in the Adult Hearing Impaired
Primary Purpose
Hearing Impaired
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Hearing Aids
Sponsored by
About this trial
This is an interventional treatment trial for Hearing Impaired focused on measuring Audiology, Hearing, Hearing Aids, Quality of Life
Eligibility Criteria
Inclusion Criteria: Hearing impaired Exclusion Criteria:
Sites / Locations
- VA Medical Center, Bay Pines
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
WHO-DAS II
Secondary Outcome Measures
Full Information
NCT ID
NCT00037986
First Posted
May 24, 2002
Last Updated
February 9, 2009
Sponsor
US Department of Veterans Affairs
1. Study Identification
Unique Protocol Identification Number
NCT00037986
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
July 2001 (undefined)
Primary Completion Date
May 2004 (Actual)
Study Completion Date
June 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
US Department of Veterans Affairs
4. Oversight
5. Study Description
Brief Summary
The short-term research objectives of the proposed study are as follows:
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.
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.
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.
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.
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.
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.).
Detailed Description
Specific Objectives with Projected Timetable:
. Short-term objectives:
. 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).
. 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.
. 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.
. 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.
. 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.
. To determine and compare cost-effectiveness of hearing aid intervention as calculated using WHO-DAS II and MOS-SF36V outcome data.
. 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.).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Impaired
Keywords
Audiology, Hearing, Hearing Aids, Quality of Life
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
330 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Hearing Aids
Intervention Description
Hearing aid use
Primary Outcome Measure Information:
Title
WHO-DAS II
Time Frame
2, 6, and 12 months post intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Hearing impaired
Exclusion Criteria:
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harvey Abrams, PhD
Organizational Affiliation
VA Medical Center, Bay Pines
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Medical Center, Bay Pines
City
Bay Pines
State/Province
Florida
ZIP/Postal Code
33708
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
16244757
Citation
Abrams HB, Chisolm TH, McArdle R. Health-related quality of life and hearing aids: a tutorial. Trends Amplif. 2005;9(3):99-109. doi: 10.1177/108471380500900302.
Results Reference
result
PubMed Identifier
16244759
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. doi: 10.1177/108471380500900304. Erratum In: Trends Amplif. 2006;10(2):105.
Results Reference
result
PubMed Identifier
16244758
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. doi: 10.1177/108471380500900303.
Results Reference
result
Learn more about this trial
Functioning, Disability, and Quality of Life in the Adult Hearing Impaired
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