Trial Outcomes & Findings for Evaluating the Carter Institute Caregiver Education Program at the VA (NCT NCT00271375)
NCT ID: NCT00271375
Last Updated: 2016-05-30
Results Overview
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.
COMPLETED
NA
254 participants
18 Months
2016-05-30
Participant Flow
Participant milestones
| Measure |
Caring for You, Caring for me Educational Intervention
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 (Educational Int
Caring for you, caring for me + social worker: 5-week Education and Support Program for Caregivers of older adults.+ augmentation with social worker
|
Control Group Usual Care
Control: Control group usual care
|
|---|---|---|---|
|
Overall Study
STARTED
|
114
|
83
|
57
|
|
Overall Study
COMPLETED
|
114
|
83
|
57
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluating the Carter Institute Caregiver Education Program at the VA
Baseline characteristics by cohort
| Measure |
Caring for You, Caring for me Educational Intervention
n=114 Participants
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 (Educational Int
n=83 Participants
Caring for you, caring for me + social worker: 5-week Education and Support Program for Caregivers of older adults.+ augmentation with social worker
|
Control Group Usual Care
n=57 Participants
Control: Control group usual care
|
Total
n=254 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
66.9 Years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
63.4 Years
STANDARD_DEVIATION 11.7 • n=7 Participants
|
61.1 Years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
64.69 Years
STANDARD_DEVIATION 11.24 • n=4 Participants
|
|
Sex: Female, Male
Female
|
111 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
238 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
38 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
93 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
74 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
156 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 18 MonthsPopulation: 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.
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.
Outcome measures
| Measure |
Overall Evaluation
n=71 Participants
Caring For You, Caring For Me: 5-week Education and Support Program for Caregivers of older adults.
|
Arm 2: Caring for You, Caring for me + Social Worker (Educati
Caring for you, caring for me + social worker: 5-week Education and Support Program for Caregivers of older adults.+ augmentation with social worker
|
Arm 3: Control Group Usual Care
Control: Control group usual care
|
|---|---|---|---|
|
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
Excellent
|
31 participants
|
—
|
—
|
|
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
Very Good
|
32 participants
|
—
|
—
|
|
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
Good
|
8 participants
|
—
|
—
|
|
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
Fair
|
0 participants
|
—
|
—
|
|
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
Poor
|
0 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 6 Month Follow-up, 12 Month Follow-upSubjective 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).
Outcome measures
| Measure |
Overall Evaluation
n=114 Participants
Caring For You, Caring For Me: 5-week Education and Support Program for Caregivers of older adults.
|
Arm 2: Caring for You, Caring for me + Social Worker (Educati
n=83 Participants
Caring for you, caring for me + social worker: 5-week Education and Support Program for Caregivers of older adults.+ augmentation with social worker
|
Arm 3: Control Group Usual Care
n=57 Participants
Control: Control group usual care
|
|---|---|---|---|
|
Subjective Health
Baseline
|
3.49 units on a scale
Standard Deviation .83
|
3.68 units on a scale
Standard Deviation .77
|
3.37 units on a scale
Standard Deviation .64
|
|
Subjective Health
6 Month Follow-up
|
3.11 units on a scale
Standard Deviation .62
|
3.17 units on a scale
Standard Deviation .58
|
3.12 units on a scale
Standard Deviation .59
|
|
Subjective Health
12 month Follow-up
|
3.06 units on a scale
Standard Deviation .67
|
3.19 units on a scale
Standard Deviation .72
|
3.05 units on a scale
Standard Deviation .44
|
SECONDARY outcome
Timeframe: Baseline, 6 Month Follow-up, 12 Month Follow-upPhysical 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).
Outcome measures
| Measure |
Overall Evaluation
n=114 Participants
Caring For You, Caring For Me: 5-week Education and Support Program for Caregivers of older adults.
|
Arm 2: Caring for You, Caring for me + Social Worker (Educati
n=83 Participants
Caring for you, caring for me + social worker: 5-week Education and Support Program for Caregivers of older adults.+ augmentation with social worker
|
Arm 3: Control Group Usual Care
n=57 Participants
Control: Control group usual care
|
|---|---|---|---|
|
Physical Role Function
Baseline
|
3.88 units on a scale
Standard Deviation 1.06
|
4.33 units on a scale
Standard Deviation 1.01
|
3.90 units on a scale
Standard Deviation 0.93
|
|
Physical Role Function
6 Month Follow-up
|
3.90 units on a scale
Standard Deviation .98
|
4.11 units on a scale
Standard Deviation 0.94
|
4.16 units on a scale
Standard Deviation 0.88
|
|
Physical Role Function
12 Month Follow-up
|
3.80 units on a scale
Standard Deviation 0.98
|
4.20 units on a scale
Standard Deviation 0.98
|
4.19 units on a scale
Standard Deviation 0.77
|
SECONDARY outcome
Timeframe: Baseline, 6 Month Follow-up, 12 Month Follow-upPhysical 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).
Outcome measures
| Measure |
Overall Evaluation
n=114 Participants
Caring For You, Caring For Me: 5-week Education and Support Program for Caregivers of older adults.
|
Arm 2: Caring for You, Caring for me + Social Worker (Educati
n=83 Participants
Caring for you, caring for me + social worker: 5-week Education and Support Program for Caregivers of older adults.+ augmentation with social worker
|
Arm 3: Control Group Usual Care
n=57 Participants
Control: Control group usual care
|
|---|---|---|---|
|
Physical Function
12 Month Follow-up
|
2.31 units on a scale
Standard Deviation .57
|
2.62 units on a scale
Standard Deviation .45
|
1.57 units on a scale
Standard Deviation .38
|
|
Physical Function
Baseline
|
2.36 units on a scale
Standard Deviation .52
|
2.52 units on a scale
Standard Deviation .48
|
2.58 units on a scale
Standard Deviation .40
|
|
Physical Function
6 Month Follow-up
|
2.39 units on a scale
Standard Deviation .51
|
2.64 units on a scale
Standard Deviation .41
|
2.68 units on a scale
Standard Deviation .37
|
SECONDARY outcome
Timeframe: Baseline, 6 Month Follow-up, 12 Month Follow-upDepression 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).
Outcome measures
| Measure |
Overall Evaluation
n=114 Participants
Caring For You, Caring For Me: 5-week Education and Support Program for Caregivers of older adults.
|
Arm 2: Caring for You, Caring for me + Social Worker (Educati
n=83 Participants
Caring for you, caring for me + social worker: 5-week Education and Support Program for Caregivers of older adults.+ augmentation with social worker
|
Arm 3: Control Group Usual Care
n=57 Participants
Control: Control group usual care
|
|---|---|---|---|
|
Depressive Symptoms
12 Month Follow-up
|
11.37 units on a scale
Standard Deviation 9.37
|
7.50 units on a scale
Standard Deviation 7.18
|
11.41 units on a scale
Standard Deviation 9.42
|
|
Depressive Symptoms
Baseline
|
10.54 units on a scale
Standard Deviation 9.67
|
9.96 units on a scale
Standard Deviation 7.97
|
12.18 units on a scale
Standard Deviation 12.64
|
|
Depressive Symptoms
6 Month Follow-up
|
9.27 units on a scale
Standard Deviation 7.96
|
8.29 units on a scale
Standard Deviation 8.07
|
12.47 units on a scale
Standard Deviation 11.79
|
SECONDARY outcome
Timeframe: Baseline, 6 Month Follow-up, 12 Month Follow-upCaregiver 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).
Outcome measures
| Measure |
Overall Evaluation
n=114 Participants
Caring For You, Caring For Me: 5-week Education and Support Program for Caregivers of older adults.
|
Arm 2: Caring for You, Caring for me + Social Worker (Educati
n=83 Participants
Caring for you, caring for me + social worker: 5-week Education and Support Program for Caregivers of older adults.+ augmentation with social worker
|
Arm 3: Control Group Usual Care
n=57 Participants
Control: Control group usual care
|
|---|---|---|---|
|
Caregiver Burden
Baseline
|
23.02 units on a scale
Standard Deviation 8.62
|
23.93 units on a scale
Standard Deviation 8.27
|
23.41 units on a scale
Standard Deviation 8.48
|
|
Caregiver Burden
6 Month Follow-up
|
22.61 units on a scale
Standard Deviation 6.61
|
22.07 units on a scale
Standard Deviation 7.43
|
22.65 units on a scale
Standard Deviation 8.29
|
|
Caregiver Burden
12 Month Follow-up
|
23.68 units on a scale
Standard Deviation 8.44
|
21.57 units on a scale
Standard Deviation 7.69
|
21.06 units on a scale
Standard Deviation 8.18
|
SECONDARY outcome
Timeframe: Baseline, 6 Month Follow-up, 12 Month Follow-upCaregiver 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).
Outcome measures
| Measure |
Overall Evaluation
n=114 Participants
Caring For You, Caring For Me: 5-week Education and Support Program for Caregivers of older adults.
|
Arm 2: Caring for You, Caring for me + Social Worker (Educati
n=83 Participants
Caring for you, caring for me + social worker: 5-week Education and Support Program for Caregivers of older adults.+ augmentation with social worker
|
Arm 3: Control Group Usual Care
n=57 Participants
Control: Control group usual care
|
|---|---|---|---|
|
Caregiver Satisfaction
Baseline
|
23.15 units on a scale
Standard Deviation 4.26
|
23.5 units on a scale
Standard Deviation 5.44
|
26.00 units on a scale
Standard Deviation 3.16
|
|
Caregiver Satisfaction
6 Month Follow-up
|
23.02 units on a scale
Standard Deviation 4.64
|
23.43 units on a scale
Standard Deviation 4.98
|
25.88 units on a scale
Standard Deviation 3.81
|
|
Caregiver Satisfaction
12 Month Follow-up
|
22.83 units on a scale
Standard Deviation 4.97
|
23.50 units on a scale
Standard Deviation 4.81
|
25.18 units on a scale
Standard Deviation 4.63
|
SECONDARY outcome
Timeframe: Baseline, 6 Month Follow-up, 12 Month Follow-upCaregiver 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).
Outcome measures
| Measure |
Overall Evaluation
n=114 Participants
Caring For You, Caring For Me: 5-week Education and Support Program for Caregivers of older adults.
|
Arm 2: Caring for You, Caring for me + Social Worker (Educati
n=83 Participants
Caring for you, caring for me + social worker: 5-week Education and Support Program for Caregivers of older adults.+ augmentation with social worker
|
Arm 3: Control Group Usual Care
n=57 Participants
Control: Control group usual care
|
|---|---|---|---|
|
Caregiver Mastery
6 Month Follow-up
|
10.90 units on a scale
Standard Deviation 2.41
|
11.21 units on a scale
Standard Deviation 2.13
|
9.59 units on a scale
Standard Deviation 1.73
|
|
Caregiver Mastery
Baseline
|
13.51 units on a scale
Standard Deviation 3.50
|
13.25 units on a scale
Standard Deviation 3.34
|
11.59 units on a scale
Standard Deviation 3.06
|
|
Caregiver Mastery
12 Month Follow-up
|
6.88 units on a scale
Standard Deviation 2.23
|
7.04 units on a scale
Standard Deviation 1.86
|
6.24 units on a scale
Standard Deviation 2.28
|
SECONDARY outcome
Timeframe: Baseline, 6 Month Follow-up, 12 Month Follow-upCaregiver 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).
Outcome measures
| Measure |
Overall Evaluation
n=114 Participants
Caring For You, Caring For Me: 5-week Education and Support Program for Caregivers of older adults.
|
Arm 2: Caring for You, Caring for me + Social Worker (Educati
n=83 Participants
Caring for you, caring for me + social worker: 5-week Education and Support Program for Caregivers of older adults.+ augmentation with social worker
|
Arm 3: Control Group Usual Care
n=57 Participants
Control: Control group usual care
|
|---|---|---|---|
|
Caregiver Efficacy
Baseline
|
4.15 units on a scale
Standard Deviation 0.65
|
4.16 units on a scale
Standard Deviation 0.52
|
4.78 units on a scale
Standard Deviation 0.41
|
|
Caregiver Efficacy
6 Month Follow-up
|
4.15 units on a scale
Standard Deviation 0.47
|
4.18 units on a scale
Standard Deviation 0.52
|
4.15 units on a scale
Standard Deviation 0.55
|
|
Caregiver Efficacy
12 Month Follow-up
|
4.09 units on a scale
Standard Deviation 0.52
|
4.22 units on a scale
Standard Deviation 0.50
|
4.17 units on a scale
Standard Deviation 0.47
|
SECONDARY outcome
Timeframe: Baseline, 6 Month Follow-up, 12 Month Follow-upCaregiver 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).
Outcome measures
| Measure |
Overall Evaluation
n=114 Participants
Caring For You, Caring For Me: 5-week Education and Support Program for Caregivers of older adults.
|
Arm 2: Caring for You, Caring for me + Social Worker (Educati
n=83 Participants
Caring for you, caring for me + social worker: 5-week Education and Support Program for Caregivers of older adults.+ augmentation with social worker
|
Arm 3: Control Group Usual Care
n=57 Participants
Control: Control group usual care
|
|---|---|---|---|
|
Personal Mastery
6 Month Follow-up
|
3.64 units on a scale
Standard Deviation 0.76
|
3.90 units on a scale
Standard Deviation 0.77
|
3.56 units on a scale
Standard Deviation 0.54
|
|
Personal Mastery
Baseline
|
3.60 units on a scale
Standard Deviation 0.73
|
3.84 units on a scale
Standard Deviation 0.65
|
3.50 units on a scale
Standard Deviation 0.74
|
|
Personal Mastery
12 Month Follow-up
|
3.70 units on a scale
Standard Deviation 0.79
|
3.89 units on a scale
Standard Deviation 0.76
|
3.52 units on a scale
Standard Deviation 0.86
|
SECONDARY outcome
Timeframe: Baseline, 6 Month Follow-up, 12 Month Follow-upCaregiver 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).
Outcome measures
| Measure |
Overall Evaluation
n=114 Participants
Caring For You, Caring For Me: 5-week Education and Support Program for Caregivers of older adults.
|
Arm 2: Caring for You, Caring for me + Social Worker (Educati
n=83 Participants
Caring for you, caring for me + social worker: 5-week Education and Support Program for Caregivers of older adults.+ augmentation with social worker
|
Arm 3: Control Group Usual Care
n=57 Participants
Control: Control group usual care
|
|---|---|---|---|
|
Perceived Social Support
Baseline
|
3.70 units on a scale
Standard Deviation 0.81
|
3.77 units on a scale
Standard Deviation 0.90
|
3.70 units on a scale
Standard Deviation 0.76
|
|
Perceived Social Support
6 Month Follow-up
|
3.65 units on a scale
Standard Deviation 0.76
|
3.81 units on a scale
Standard Deviation 0.87
|
3.81 units on a scale
Standard Deviation 0.92
|
|
Perceived Social Support
12 Month Follow-up
|
3.72 units on a scale
Standard Deviation 0.81
|
3.79 units on a scale
Standard Deviation 0.90
|
3.51 units on a scale
Standard Deviation 0.77
|
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
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place