Evaluating the Carter Institute Caregiver Education Program at the VA

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00271375
First received: December 29, 2005
Last updated: April 22, 2016
Last verified: April 2016
  Purpose
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).

Condition Intervention
Caregivers
Behavioral: Caring For You, Caring For Me
Behavioral: Caring for you, caring for me + social worker
Behavioral: Control

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Health Services Research
Official Title: Evaluating the Carter Institute Caregiver Education Program at the VA

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Subjective Health [ Time Frame: Baseline, 6 Month Follow-up, 12 Month Follow-up ] [ Designated as safety issue: No ]
    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).

  • Physical Role Function [ Time Frame: Baseline, 6 Month Follow-up, 12 Month Follow-up ] [ Designated as safety issue: No ]
    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).

  • Physical Function [ Time Frame: Baseline, 6 Month Follow-up, 12 Month Follow-up ] [ Designated as safety issue: No ]
    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).

  • Depressive Symptoms [ Time Frame: Baseline, 6 Month Follow-up, 12 Month Follow-up ] [ Designated as safety issue: No ]
    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).

  • Caregiver Burden [ Time Frame: Baseline, 6 Month Follow-up, 12 Month Follow-up ] [ Designated as safety issue: No ]
    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).

  • Caregiver Satisfaction [ Time Frame: Baseline, 6 Month Follow-up, 12 Month Follow-up ] [ Designated as safety issue: No ]
    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).

  • Caregiver Mastery [ Time Frame: Baseline, 6 Month Follow-up, 12 Month Follow-up ] [ Designated as safety issue: No ]
    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).

  • Caregiver Efficacy [ Time Frame: Baseline, 6 Month Follow-up, 12 Month Follow-up ] [ Designated as safety issue: No ]
    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).

  • Personal Mastery [ Time Frame: Baseline, 6 Month Follow-up, 12 Month Follow-up ] [ Designated as safety issue: No ]
    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).

  • Perceived Social Support [ Time Frame: Baseline, 6 Month Follow-up, 12 Month Follow-up ] [ Designated as safety issue: No ]
    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).


Enrollment: 254
Study Start Date: October 2005
Study Completion Date: October 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1: Caring for you, Caring for me Educational Intervention
Educational Intervention
Behavioral: Caring For You, Caring For Me
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
Behavioral: Caring for you, caring for me + social worker
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
Behavioral: Control
Control group usual care

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 .
  Eligibility

Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00271375

Locations
United States, Georgia
VA Medical Center, Decatur
Decatur, Georgia, United States, 30033
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Patricia Griffiths, PhD Atlanta VAMC
  More Information

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00271375     History of Changes
Other Study ID Numbers: E4044-R  IRB 2005-050240  IRB 278-2005 
Study First Received: December 29, 2005
Results First Received: October 16, 2014
Last Updated: April 22, 2016
Health Authority: United States: Federal Government

Keywords provided by VA Office of Research and Development:
Age
Caregivers
Family
Intervention Studies

ClinicalTrials.gov processed this record on July 27, 2016