Evaluating the Carter Institute Caregiver Education Program at the VA

April 22, 2016 updated by: VA Office of Research and Development
This project implemented and evaluated the Rosalyn Carter Institute's (RCI's) educational and support program for caregivers, "Caring for You, Caring for Me." Specifically, it examined 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).

Study Overview

Detailed Description

Primary objectives of the research were:

  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 .

Study Type

Interventional

Enrollment (Actual)

254

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Georgia
      • Decatur, Georgia, United States, 30033
        • VA Medical Center, Decatur

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1: Caring for you, Caring for me Educational Intervention
Educational Intervention
5-week Education and Support Program for Caregivers of older adults.
Experimental: Arm 2: Caring for you, caring for me + social worker
Educational + Social Work Intervention
5-week Education and Support Program for Caregivers of older adults.+ augmentation with social worker
Placebo Comparator: Arm 3: Control group usual care
Control group usual care
Control group usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 18 Months
This question addresses user satisfaction, in terms of caregiving perceived utility of the education program, as well as their actual use of knowledge and skills gained in their caregiving situation.
18 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective Health
Time Frame: Baseline, 6 Month Follow-up, 12 Month Follow-up
Subjective Health was assessed using one of the eight subscales from the Medical Outcomes Study Health Survey Short Form (SF-36) which looked at the how the respondent (caregiver) perceived their own health currently and compared to a year ago. Two items were based on a 5-point Likert scale (1 =Excellent and 5= Poor) with a total scale range between 1 and 5. Mean scores were calculated by finding the total sum divided by the total number of items, with higher scores indicating poorer outcomes. Calculations were completed at each time interval (baseline, 6month follow-up, and 12month follow-up) and for each study arm (Arm 1, Arm 2 and Arm 3).
Baseline, 6 Month Follow-up, 12 Month Follow-up
Physical Role Function
Time Frame: Baseline, 6 Month Follow-up, 12 Month Follow-up
Physical Role Function was assessed using one of the eight subscales from the Medical Outcomes Study Health Survey Short Form (SF-36) which looked at how emotional or physical issues interfered with everyday social roles of the caregiver. 4 items were scored on a 5-point Likert scale (1 = All of the time and 5= None of the time) with total scale range between 1 and 5. Mean scores were calculated by finding the total sum divided by the total item number, with lower scores indicating poorer outcome. Calculations were completed at each time interval (baseline, 6month follow-up, and 12month follow-up) and for each study arm (Arm 1, Arm 2 and Arm 3).
Baseline, 6 Month Follow-up, 12 Month Follow-up
Physical Function
Time Frame: Baseline, 6 Month Follow-up, 12 Month Follow-up
Physical function was assessed using one of the eight subscales from the Medical Outcomes Study Health Survey Short Form (SF-36) which is represented by 10 items tapping basic functional abilities of the caregiver (Does their health limit them in the following activities). 10 items were scored on a 3-Point Likert Scale with 1= Limited A lot and 3= Not Limited and total scale range between 1 and 3. Mean scores were calculated by finding the total sum divided by the total item number, with lower scores indicating poorer outcome. Calculations were completed at each time interval (baseline, 6month follow-up, and 12month follow-up) and for each study arm (Arm 1, Arm 2 and Arm 3).
Baseline, 6 Month Follow-up, 12 Month Follow-up
Depressive Symptoms
Time Frame: Baseline, 6 Month Follow-up, 12 Month Follow-up
Depression symptoms were assessed using the Center for Epidemiological Studies Depression Scale (CES-D Short Form). The CES-D is a 10 Question Scale with total scores ranging from 0-30. Mean scores were calculated by finding the total sum divided by the total number of participants. Any score equal to or above 10 is considered depressed. Calculations were completed at each time interval (baseline, 6month follow-up, and 12month follow-up) and for each study arm (Arm 1, Arm 2 and Arm 3).
Baseline, 6 Month Follow-up, 12 Month Follow-up
Caregiver Burden
Time Frame: Baseline, 6 Month Follow-up, 12 Month Follow-up
Caregiver Burden was assessed using one of the five subscales from the revised Caregiver Appraisal Scale (CAS) through 9-items based on a 5-point likert scale with (1 = Never and 5= Nearly always). Mean for the total scores, calculated as the total sum divided by the number of participants, where scores could range from 9 to 45 were calculated, with higher scores indicating poorer outcomes. Calculations were completed at each time interval (baseline, 6month follow-up, and 12month follow-up) and for each study arm (Arm 1, Arm 2 and Arm 3).
Baseline, 6 Month Follow-up, 12 Month Follow-up
Caregiver Satisfaction
Time Frame: Baseline, 6 Month Follow-up, 12 Month Follow-up
Caregiver Satisfaction was assessed using one of the five subscales from the revised Caregiver Appraisal Scale (CAS) through 6-items based on a 5-point likert scale with (1 = Disagree A lot and 5= Agree A lot). Mean for the total scores, calculated as the total sum divided by the number of participants, where scores could range from 6 to 30 were calculated, with higher scores indicating poorer outcomes. Calculations were completed at each time interval (baseline, 6month follow-up, and 12month follow-up) and for each study arm (Arm 1, Arm 2 and Arm 3).
Baseline, 6 Month Follow-up, 12 Month Follow-up
Caregiver Mastery
Time Frame: Baseline, 6 Month Follow-up, 12 Month Follow-up
Caregiver Mastery was assessed using one of the five subscales from the revised Caregiver Appraisal Scale (CAS) through a 4-item question assessing a sense of doing a good job of care provision based on a 5-point likert scale with (5= Agree A lot and 1= Disagree A lot). Mean for the total scores, calculated as the total sum divided by the number of participants, where scores could range from 5 to 20 were calculated, with higher scores indicating poorer outcome. Calculations were completed at each time interval (baseline, 6month follow-up, and 12month follow-up) and for each study arm (Arm 1, Arm 2 and Arm 3).
Baseline, 6 Month Follow-up, 12 Month Follow-up
Caregiver Efficacy
Time Frame: Baseline, 6 Month Follow-up, 12 Month Follow-up
Caregiver Efficacy was assessed using the RIS Eldercare Self Efficacy Scale (RIS) a 10-item inventory addressing family caregiver's perception of their own ability to manage care provision challenges in the areas of relationship with the care recipient, instrumental care provision, and self-soothing (managing the strains of care provision) based on a 5-point likert scale with (1 = Im certain I CANNOT Do This and 5= Im certain I CAN Do This) with a total score range between1 and 5. Mean scores were calculated by finding the total sum divided by the total item number, higher scores indicating better outcome. Calculations were completed at each time interval (baseline, 6month follow-up, and 12month follow-up) and for each study arm (Arm 1, Arm 2 and Arm 3).
Baseline, 6 Month Follow-up, 12 Month Follow-up
Personal Mastery
Time Frame: Baseline, 6 Month Follow-up, 12 Month Follow-up
Caregiver Personal Mastery was assessed using the Personal Mastery Scale which afforded a general measure of self-perceived ability to manage stressors and effect change in one's life through a 7-item question based on a 5-point likert scale with (5 = Agree A lot and 1= Disagree A lot) and a total score range between 1 and 5. Mean scores were calculated by finding the total sum divided by the total item number, with higher scores indicating poorer outcome. Calculations were completed at each time interval (baseline, 6month follow-up, and 12month follow-up) and for each study arm (Arm 1, Arm 2 and Arm 3).
Baseline, 6 Month Follow-up, 12 Month Follow-up
Perceived Social Support
Time Frame: Baseline, 6 Month Follow-up, 12 Month Follow-up
Caregiver Perceived Social Support was assessed using the Medical Outcomes Study Social Support Survey (MOS-SSS) a 19-item scale that taps perceived emotional/informational, tangible, and affectionate support, and positive social interaction based on a 5-point likert scale with (1 = None of the time and 5= All of the time) with total score range between 1 and 5. Mean scores were calculated by finding the total sum divided by the total item number, with higher scores indicating better outcome. Calculations were completed at each time interval (baseline, 6month follow-up, and 12month follow-up) and for each study arm (Arm 1, Arm 2 and Arm 3).
Baseline, 6 Month Follow-up, 12 Month Follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Patricia Griffiths, PhD, Atlanta VAMC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

December 29, 2005

First Submitted That Met QC Criteria

December 29, 2005

First Posted (Estimate)

December 30, 2005

Study Record Updates

Last Update Posted (Estimate)

May 30, 2016

Last Update Submitted That Met QC Criteria

April 22, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • E4044-R
  • IRB 2005-050240 (Other Identifier: Atlanta VAMC)
  • IRB 278-2005 (Other Identifier: Emory University IRB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Caregivers

Clinical Trials on Caring For You, Caring For Me

3
Subscribe