Clinical trial NCT00037986: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hearing Impaired
Keywords: Audiology
Hearing
Hearing Aids
Quality of Life
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2002-05-27
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 (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.).

Detailed description: Specific Objectives with Projected Timetable:

1. . 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.
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 criteria: Inclusion Criteria:

Hearing impaired

Exclusion Criteria:

Primary outcomes:
measure: WHO-DAS II
timeFrame: 2, 6, and 12 months post intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Bay Pines
country: United States
facility: VA Medical Center, Bay Pines
state: Florida
Study officials:
affiliation: VA Medical Center, Bay Pines
name: Harvey Abrams, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.