Effectiveness of a Health Education Program in a Primary Care Setting

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00012779
First received: March 14, 2001
Last updated: April 16, 2014
Last verified: April 2014
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effectiveness of a Health Education Program in a Primary Care Setting

Further study details as provided by Department of Veterans Affairs:

Estimated Enrollment: 288
Study Completion Date: March 2003
Arms Assigned Interventions
Arm 1 Behavioral: Health Education Program

Detailed Description:

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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00012779

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
Sponsors and Collaborators
Investigators
Principal Investigator: Joseph B. Engelhardt, PhD VA Health Care Network Upstate New York
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00012779     History of Changes
Other Study ID Numbers: IIR 95-118
Study First Received: March 14, 2001
Last Updated: April 16, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Health Care Education
Health Care Cost

ClinicalTrials.gov processed this record on September 18, 2014