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Evaluating the Carter Institute Caregiver Education Program at the VA

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ClinicalTrials.gov Identifier: NCT00271375
Recruitment Status : Completed
First Posted : December 30, 2005
Results First Posted : May 30, 2016
Last Update Posted : May 30, 2016
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Factorial Assignment;   Masking: Single (Care Provider);   Primary Purpose: Health Services Research
Condition Caregivers
Interventions Behavioral: Caring For You, Caring For Me
Behavioral: Caring for you, caring for me + social worker
Behavioral: Control
Enrollment 254

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Caring for You, Caring for me Educational Intervention Caring for You, Caring for me + Social Worker (Educational Int Control Group Usual Care
Hide Arm/Group Description Caring For You, Caring For Me: 5-week Education and Support Program for Caregivers of older adults. Caring for you, caring for me + social worker: 5-week Education and Support Program for Caregivers of older adults.+ augmentation with social worker Control: Control group usual care
Period Title: Overall Study
Started 114 83 57
Completed 114 83 57
Not Completed 0 0 0
Arm/Group Title Caring for You, Caring for me Educational Intervention Caring for You, Caring for me + Social Worker (Educational Int Control Group Usual Care Total
Hide Arm/Group Description Caring For You, Caring For Me: 5-week Education and Support Program for Caregivers of older adults. Caring for you, caring for me + social worker: 5-week Education and Support Program for Caregivers of older adults.+ augmentation with social worker Control: Control group usual care Total of all reporting groups
Overall Number of Baseline Participants 114 83 57 254
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 114 participants 83 participants 57 participants 254 participants
66.9  (11.0) 63.4  (11.7) 61.1  (9.8) 64.69  (11.24)
[1]
Measure Description: Age
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 114 participants 83 participants 57 participants 254 participants
Female
111
  97.4%
76
  91.6%
51
  89.5%
238
  93.7%
Male
3
   2.6%
7
   8.4%
6
  10.5%
16
   6.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 114 participants 83 participants 57 participants 254 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
38
  33.3%
31
  37.3%
24
  42.1%
93
  36.6%
White
74
  64.9%
52
  62.7%
30
  52.6%
156
  61.4%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
2
   1.8%
0
   0.0%
3
   5.3%
5
   2.0%
1.Primary Outcome
Title 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
Hide Description 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.
Time Frame 18 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
User evaluation of the "Caring for you, Caring for me" education program. Data for participants in the "Caring for you, Caring for me" education program only and "Caring for you, Caring for me" education program+ Social Work were combined during data collection. Only 71 participants provided results. No data was collected from control group.
Arm/Group Title Overall Evaluation
Hide Arm/Group Description:
Caring For You, Caring For Me: 5-week Education and Support Program for Caregivers of older adults.
Overall Number of Participants Analyzed 71
Measure Type: Number
Unit of Measure: participants
Excellent 31
Very Good 32
Good 8
Fair 0
Poor 0
2.Secondary Outcome
Title Subjective Health
Hide Description 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).
Time Frame Baseline, 6 Month Follow-up, 12 Month Follow-up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1: Caring for You, Caring for me Educational Intervention Arm 2: Caring for You, Caring for me + Social Worker (Educati Arm 3: Control Group Usual Care
Hide Arm/Group Description:
Caring For You, Caring For Me: 5-week Education and Support Program for Caregivers of older adults.
Caring for you, caring for me + social worker: 5-week Education and Support Program for Caregivers of older adults.+ augmentation with social worker
Control: Control group usual care
Overall Number of Participants Analyzed 114 83 57
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 3.49  (.83) 3.68  (.77) 3.37  (.64)
6 Month Follow-up 3.11  (.62) 3.17  (.58) 3.12  (.59)
12 month Follow-up 3.06  (.67) 3.19  (.72) 3.05  (.44)
3.Secondary Outcome
Title Physical Role Function
Hide Description 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).
Time Frame Baseline, 6 Month Follow-up, 12 Month Follow-up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1: Caring for You, Caring for me Educational Intervention Arm 2: Caring for You, Caring for me + Social Worker (Educati Arm 3: Control Group Usual Care
Hide Arm/Group Description:
Caring For You, Caring For Me: 5-week Education and Support Program for Caregivers of older adults.
Caring for you, caring for me + social worker: 5-week Education and Support Program for Caregivers of older adults.+ augmentation with social worker
Control: Control group usual care
Overall Number of Participants Analyzed 114 83 57
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 3.88  (1.06) 4.33  (1.01) 3.90  (0.93)
6 Month Follow-up 3.90  (.98) 4.11  (0.94) 4.16  (0.88)
12 Month Follow-up 3.80  (0.98) 4.20  (0.98) 4.19  (0.77)
4.Secondary Outcome
Title Physical Function
Hide Description 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).
Time Frame Baseline, 6 Month Follow-up, 12 Month Follow-up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1: Caring for You, Caring for me Educational Intervention Arm 2: Caring for You, Caring for me + Social Worker (Educati Arm 3: Control Group Usual Care
Hide Arm/Group Description:
Caring For You, Caring For Me: 5-week Education and Support Program for Caregivers of older adults.
Caring for you, caring for me + social worker: 5-week Education and Support Program for Caregivers of older adults.+ augmentation with social worker
Control: Control group usual care
Overall Number of Participants Analyzed 114 83 57
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 2.36  (.52) 2.52  (.48) 2.58  (.40)
6 Month Follow-up 2.39  (.51) 2.64  (.41) 2.68  (.37)
12 Month Follow-up 2.31  (.57) 2.62  (.45) 1.57  (.38)
5.Secondary Outcome
Title Depressive Symptoms
Hide Description 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).
Time Frame Baseline, 6 Month Follow-up, 12 Month Follow-up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1: Caring for You, Caring for me Educational Intervention Arm 2: Caring for You, Caring for me + Social Worker (Educati Arm 3: Control Group Usual Care
Hide Arm/Group Description:
Caring For You, Caring For Me: 5-week Education and Support Program for Caregivers of older adults.
Caring for you, caring for me + social worker: 5-week Education and Support Program for Caregivers of older adults.+ augmentation with social worker
Control: Control group usual care
Overall Number of Participants Analyzed 114 83 57
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 10.54  (9.67) 9.96  (7.97) 12.18  (12.64)
6 Month Follow-up 9.27  (7.96) 8.29  (8.07) 12.47  (11.79)
12 Month Follow-up 11.37  (9.37) 7.50  (7.18) 11.41  (9.42)
6.Secondary Outcome
Title Caregiver Burden
Hide Description 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).
Time Frame Baseline, 6 Month Follow-up, 12 Month Follow-up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1: Caring for You, Caring for me Educational Intervention Arm 2: Caring for You, Caring for me + Social Worker (Educati Arm 3: Control Group Usual Care
Hide Arm/Group Description:
Caring For You, Caring For Me: 5-week Education and Support Program for Caregivers of older adults.
Caring for you, caring for me + social worker: 5-week Education and Support Program for Caregivers of older adults.+ augmentation with social worker
Control: Control group usual care
Overall Number of Participants Analyzed 114 83 57
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 23.02  (8.62) 23.93  (8.27) 23.41  (8.48)
6 Month Follow-up 22.61  (6.61) 22.07  (7.43) 22.65  (8.29)
12 Month Follow-up 23.68  (8.44) 21.57  (7.69) 21.06  (8.18)
7.Secondary Outcome
Title Caregiver Satisfaction
Hide Description 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).
Time Frame Baseline, 6 Month Follow-up, 12 Month Follow-up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1: Caring for You, Caring for me Educational Intervention Arm 2: Caring for You, Caring for me + Social Worker (Educati Arm 3: Control Group Usual Care
Hide Arm/Group Description:
Caring For You, Caring For Me: 5-week Education and Support Program for Caregivers of older adults.
Caring for you, caring for me + social worker: 5-week Education and Support Program for Caregivers of older adults.+ augmentation with social worker
Control: Control group usual care
Overall Number of Participants Analyzed 114 83 57
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 23.15  (4.26) 23.5  (5.44) 26.00  (3.16)
6 Month Follow-up 23.02  (4.64) 23.43  (4.98) 25.88  (3.81)
12 Month Follow-up 22.83  (4.97) 23.50  (4.81) 25.18  (4.63)
8.Secondary Outcome
Title Caregiver Mastery
Hide Description 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).
Time Frame Baseline, 6 Month Follow-up, 12 Month Follow-up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1: Caring for You, Caring for me Educational Intervention Arm 2: Caring for You, Caring for me + Social Worker (Educati Arm 3: Control Group Usual Care
Hide Arm/Group Description:
Caring For You, Caring For Me: 5-week Education and Support Program for Caregivers of older adults.
Caring for you, caring for me + social worker: 5-week Education and Support Program for Caregivers of older adults.+ augmentation with social worker
Control: Control group usual care
Overall Number of Participants Analyzed 114 83 57
Median (Standard Deviation)
Unit of Measure: units on a scale
Baseline 13.51  (3.50) 13.25  (3.34) 11.59  (3.06)
6 Month Follow-up 10.90  (2.41) 11.21  (2.13) 9.59  (1.73)
12 Month Follow-up 6.88  (2.23) 7.04  (1.86) 6.24  (2.28)
9.Secondary Outcome
Title Caregiver Efficacy
Hide Description 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).
Time Frame Baseline, 6 Month Follow-up, 12 Month Follow-up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1: Caring for You, Caring for me Educational Intervention Arm 2: Caring for You, Caring for me + Social Worker (Educati Arm 3: Control Group Usual Care
Hide Arm/Group Description:
Caring For You, Caring For Me: 5-week Education and Support Program for Caregivers of older adults.
Caring for you, caring for me + social worker: 5-week Education and Support Program for Caregivers of older adults.+ augmentation with social worker
Control: Control group usual care
Overall Number of Participants Analyzed 114 83 57
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 4.15  (0.65) 4.16  (0.52) 4.78  (0.41)
6 Month Follow-up 4.15  (0.47) 4.18  (0.52) 4.15  (0.55)
12 Month Follow-up 4.09  (0.52) 4.22  (0.50) 4.17  (0.47)
10.Secondary Outcome
Title Personal Mastery
Hide Description 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).
Time Frame Baseline, 6 Month Follow-up, 12 Month Follow-up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1: Caring for You, Caring for me Educational Intervention Arm 2: Caring for You, Caring for me + Social Worker (Educati Arm 3: Control Group Usual Care
Hide Arm/Group Description:
Caring For You, Caring For Me: 5-week Education and Support Program for Caregivers of older adults.
Caring for you, caring for me + social worker: 5-week Education and Support Program for Caregivers of older adults.+ augmentation with social worker
Control: Control group usual care
Overall Number of Participants Analyzed 114 83 57
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 3.60  (0.73) 3.84  (0.65) 3.50  (0.74)
6 Month Follow-up 3.64  (0.76) 3.90  (0.77) 3.56  (0.54)
12 Month Follow-up 3.70  (0.79) 3.89  (0.76) 3.52  (0.86)
11.Secondary Outcome
Title Perceived Social Support
Hide Description 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).
Time Frame Baseline, 6 Month Follow-up, 12 Month Follow-up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1: Caring for You, Caring for me Educational Intervention Arm 2: Caring for You, Caring for me + Social Worker (Educati Arm 3: Control Group Usual Care
Hide Arm/Group Description:
Caring For You, Caring For Me: 5-week Education and Support Program for Caregivers of older adults.
Caring for you, caring for me + social worker: 5-week Education and Support Program for Caregivers of older adults.+ augmentation with social worker
Control: Control group usual care
Overall Number of Participants Analyzed 114 83 57
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 3.70  (0.81) 3.77  (0.90) 3.70  (0.76)
6 Month Follow-up 3.65  (0.76) 3.81  (0.87) 3.81  (0.92)
12 Month Follow-up 3.72  (0.81) 3.79  (0.90) 3.51  (0.77)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm 1: Caring for You, Caring for me Educational Intervention Arm 2: Caring for You, Caring for me + Social Worker (Educati Arm 3: Control Group Usual Care
Hide Arm/Group Description Caring For You, Caring For Me: 5-week Education and Support Program for Caregivers of older adults. Caring for you, caring for me + social worker: 5-week Education and Support Program for Caregivers of older adults.+ augmentation with social worker Control: Control group usual care
All-Cause Mortality
Arm 1: Caring for You, Caring for me Educational Intervention Arm 2: Caring for You, Caring for me + Social Worker (Educati Arm 3: Control Group Usual Care
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Arm 1: Caring for You, Caring for me Educational Intervention Arm 2: Caring for You, Caring for me + Social Worker (Educati Arm 3: Control Group Usual Care
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/114 (0.00%)   0/83 (0.00%)   0/57 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm 1: Caring for You, Caring for me Educational Intervention Arm 2: Caring for You, Caring for me + Social Worker (Educati Arm 3: Control Group Usual Care
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/114 (0.00%)   0/83 (0.00%)   0/57 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Patricia Griffiths
Organization: Atlanta VAMC
Phone: 404-321-6111 ext 7138
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00271375     History of Changes
Other Study ID Numbers: E4044-R
IRB 2005-050240 ( Other Identifier: Atlanta VAMC )
IRB 278-2005 ( Other Identifier: Emory University IRB )
First Submitted: December 29, 2005
First Posted: December 30, 2005
Results First Submitted: October 16, 2014
Results First Posted: May 30, 2016
Last Update Posted: May 30, 2016