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| Sponsor: | Department of Veterans Affairs |
|---|---|
| Information provided by: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00012779 |
Purpose
This study was designed to assess the effectiveness of a Health Education Program (HEP) for improving the well-being and reducing the health care use and cost of care of frail older outpatient veterans, and for improving the well-being of their spouse caregivers. HEP is a multi-component group program delivered in 8 weekly, 2-hour sessions, and 10 monthly 2-hour follow-up sessions, it includes emotion-focused and problem focused coping strategies, education and support.
| Condition | Intervention | Phase |
|---|---|---|
|
Frail Elderly |
Behavioral: Health Education Program |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Effectiveness of a Health Education Program in a Primary Care Setting |
| Estimated Enrollment: | 288 |
| Study Completion Date: | March 2003 |
| Arms | Assigned Interventions |
|---|---|
| 1 | Behavioral: Health Education Program |
Background:
This study was designed to assess the effectiveness of a Health Education Program (HEP) for improving the well-being and reducing the health care use and cost of care of frail older outpatient veterans, and for improving the well-being of their spouse caregivers. HEP is a multi-component group program delivered in 8 weekly, 2-hour sessions, and 10 monthly 2-hour follow-up sessions, it includes emotion-focused and problem focused coping strategies, education and support.
Objectives:
The objectives of this study are to evaluate: 1) effects of HEP on the perceived health status, emotional well-being, and social support of frail veterans; 2) effects of HEP on the perceived health, emotional well-being, social support, burden levels, self-appraisal of change, pressing problems associated with caregiving, knowledge and use of community resources by caregiver; and 3) effects of HEP on the health care use and costs of care recipients.
Methods:
HEP was evaluated using a randomized control group design. The design has two levels of intervention, HEP vs. Usual Care (UC), 3 VA medical centers (VAMCs), and 4 times of measurement (at baseline, after the 8th HEP meeting, and at 1 and 2 years after baseline). Data reported here are for 8 week and 1-year psychosocial outcomes and 18 months for VA cost. Caregivers and veterans (n = 466) were randomized in 3 VAMCs, 114 to UC and 119 to HEP. The typical caregiver was 68 years old, married, white, female, with some college education and living with the veteran. The typical veteran care recipient was 74 years old, white, male with some college education, and suffered from one or more chronic health problems. Fifteen HEP groups were conducted. Caregivers and recipients were assessed on: 1) health and functional status; 2) emotional well-being; and 3) social support. In addition, caregivers were assessed for change in coping skills, change in burden level, pressing problems, and knowledge and use of community resources. Data was analyzed using random effects regression models.
Status:
Data on two-year outcomes for health and functional status, emotional well-being, and social support of caregivers and veterans, problems associated with caregiving and Medicare plus VA costs are being collected and analyzed for an amended final report.
Eligibility| Ages Eligible for Study: | 55 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Caregiver inclusion criteria: 2) married to, and living with, the care recipient; 2) age 55 and older; 3) being the primary care provider for the care recipient and reporting at least a moderate level of burden on the Caregiver Strain Index; 4) report spouse has poor health care; and 5) receiver age 55 and suffering from chronic health condition.
Exclusion Criteria:
Contacts and Locations| United States, Massachusetts | |
| VA Boston Health Care System | |
| Brockton, Massachusetts, United States, 02301 | |
| United States, New York | |
| VA Health Care Network Upstate New York | |
| Albany, New York, United States, 12208 | |
| VA Western New York Health Care System | |
| Buffalo, New York, United States, 14215 | |
| Principal Investigator: | Joseph B. Engelhardt, PhD | VA Health Care Network Upstate New York |
More Information
| Responsible Party: | Department of Veterans Affairs ( Engelhardt, Joseph - Principal Investigator ) |
| Study ID Numbers: | IIR 95-118 |
| Study First Received: | March 14, 2001 |
| Last Updated: | October 31, 2008 |
| ClinicalTrials.gov Identifier: | NCT00012779 History of Changes |
| Health Authority: | United States: Federal Government |
|
Health Care Education Health Care Cost |