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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00271375
Other study ID # E4044-R
Secondary ID IRB 2005-050240I
Status Completed
Phase N/A
First received December 29, 2005
Last updated September 30, 2014
Start date October 2005
Est. completion date October 2009

Study information

Verified date September 2014
Source VA Office of Research and Development
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

This project will implement and evaluate the Rosalyn Carter Institute's (RCI's) educational and support program for caregivers, "Caring for You, Caring for Me." Specifically, it will examine effects of the program upon family caregivers to older adults in the Atlanta area and elderly veterans receiving outpatient primary care at the Atlanta Veterans Affairs Medical Center (VAMC).


Description:

This project will implement and evaluate the Rosalyn Carter Institute's (RCI's) educational and support program for caregivers, "Caring for You, Caring for Me." Specifically, it will examine effects of the program upon family caregivers to older adults in the Atlanta area and elderly veterans receiving outpatient primary care at the Atlanta Veterans Affairs Medical Center (VAMC).

Thus, this project has the potential not only to enhance the VA's complement of services for older veterans and their families, but also to demonstrate clearly the strengths of the RCI program.

Primary objectives of the research are:

1. to evaluate user satisfaction with and perceived utility of the "Caring for You, Caring for Me" caregiver educational program among formal (VHA staff) and informal (family) caregivers who undergo the program;

2. to assess effects of the program upon psychosocial and physical well-being of informal caregivers over a 1-year period,

3. to estimate effects of the program upon health status and service utilization of veterans whose family caregivers undergo the caregiver intervention, and

4. to determine whether an augmentation of the program, using structured follow-up to help caregivers apply program principles and knowledge, enhances its effects upon outcomes to caregivers and veterans.

The project has two secondary objectives, designed to build a foundation for further research by elucidating selected processes and effects of the intervention upon caregivers' and veterans' well-being. They are:

1. To lay a foundation for widespread implementation of the program, including feasibility, cost, and health utility gains for informal caregivers, and

2. To explore characteristics of veterans and their family caregivers that influence immediate and long-range outcomes of the intervention.


Recruitment information / eligibility

Status Completed
Enrollment 195
Est. completion date October 2009
Est. primary completion date August 2009
Accepts healthy volunteers No
Gender Both
Age group 55 Years and older
Eligibility Inclusion Criteria:

- Family members of veterans aged 65+ years and receiving care through the Atlanta VAMC's Clinic and Atlanta area.

- Must be the primary caregiver to someone 55 and over.

- Must have been assisting with at least one activity of daily living (ADL) for at least 6 months prior to beginning the intervention.

Exclusion Criteria:

- Caregivers are automatically excluded if veteran has a terminal illness with six months or less to live.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Investigator)


Related Conditions & MeSH terms


Intervention

Behavioral:
Caring For You, Caring For Me
5-week Education and Support Program for Caregivers of older adults.

Locations

Country Name City State
United States VA Medical Center, Decatur Decatur Georgia

Sponsors (1)

Lead Sponsor Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary to evaluate user satisfaction with and perceived utility of the "Caring for You, Caring for Me" caregiver educational program among formal (VHA staff) and informal (family) caregivers who undergo the program 18 Months No
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