Functioning, Disability, and Quality of Life in the Adult Hearing Impaired - Full Text View

Purpose

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.).

Condition	Intervention	Phase
Hearing Impaired	Procedure: Hearing	Phase II

Genetics Home Reference related topics:

nonsyndromic deafness

MedlinePlus related topics:

Hearing Disorders and Deafness

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study

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

Further study details as provided by Department of Veterans Affairs:

Estimated Enrollment:	330
Study Start Date:	July 2001
Study Completion Date:	June 2004

Detailed Description:

Specific Objectives with Projected Timetable:

. 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.
. 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 older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Hearing impaired

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00037986

Locations


United States, Florida
	VA Medical Center
	Bay Pines, Florida, United States

Sponsors and Collaborators

Department of Veterans Affairs

Investigators


Investigator:	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:	C2439R
First Received:	May 24, 2002
Last Updated:	December 13, 2007
ClinicalTrials.gov Identifier:	NCT00037986
Health Authority:	United States: Federal Government