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Evaluating the Carter Institute Caregiver Education Program at the VA

Evaluating the Carter Institute Caregiver Education Program at the VA

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00271375
Enrollment
254
Registered
2005-12-30
Start date
2005-10-31
Completion date
2009-10-31
Last updated
2016-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Caregivers

Keywords

Age, Caregivers, Family, Intervention Studies

Brief summary

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).

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 .

Interventions

BEHAVIORALCaring For You, Caring For Me

5-week Education and Support Program for Caregivers of older adults.

BEHAVIORALCaring for you, caring for me + social worker

5-week Education and Support Program for Caregivers of older adults.+ augmentation with social worker

BEHAVIORALControl

Control group usual care

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
NON_RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Caregiver)

Eligibility

Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
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 Program18 MonthsThis 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

MeasureTime frameDescription
Physical Role FunctionBaseline, 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).
Physical FunctionBaseline, 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).
Depressive SymptomsBaseline, 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).
Caregiver BurdenBaseline, 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).
Subjective HealthBaseline, 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).
Caregiver MasteryBaseline, 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).
Caregiver EfficacyBaseline, 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).
Personal MasteryBaseline, 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).
Perceived Social SupportBaseline, 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).
Caregiver SatisfactionBaseline, 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).

Countries

United States

Participant flow

Participants by arm

ArmCount
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.
114
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
83
Control Group Usual Care
Control: Control group usual care
57
Total254

Baseline characteristics

CharacteristicCaring for You, Caring for me Educational InterventionCaring for You, Caring for me + Social Worker (Educational IntControl Group Usual CareTotal
Age, Continuous66.9 Years
STANDARD_DEVIATION 11
63.4 Years
STANDARD_DEVIATION 11.7
61.1 Years
STANDARD_DEVIATION 9.8
64.69 Years
STANDARD_DEVIATION 11.24
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
38 Participants31 Participants24 Participants93 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
2 Participants0 Participants3 Participants5 Participants
Race (NIH/OMB)
White
74 Participants52 Participants30 Participants156 Participants
Sex: Female, Male
Female
111 Participants76 Participants51 Participants238 Participants
Sex: Female, Male
Male
3 Participants7 Participants6 Participants16 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —
other
Total, other adverse events
0 / 1140 / 830 / 57
serious
Total, serious adverse events
0 / 1140 / 830 / 57

Outcome results

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

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

Population: 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.

ArmMeasureGroupValue (NUMBER)
Overall EvaluationTo 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 ProgramPoor0 participants
Overall EvaluationTo 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 ProgramExcellent31 participants
Overall EvaluationTo 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 ProgramVery Good32 participants
Overall EvaluationTo 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 ProgramGood8 participants
Overall EvaluationTo 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 ProgramFair0 participants
Secondary

Caregiver Burden

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

ArmMeasureGroupValue (MEAN)Dispersion
Overall EvaluationCaregiver BurdenBaseline23.02 units on a scaleStandard Deviation 8.62
Overall EvaluationCaregiver Burden12 Month Follow-up23.68 units on a scaleStandard Deviation 8.44
Overall EvaluationCaregiver Burden6 Month Follow-up22.61 units on a scaleStandard Deviation 6.61
Arm 2: Caring for You, Caring for me + Social Worker (EducatiCaregiver BurdenBaseline23.93 units on a scaleStandard Deviation 8.27
Arm 2: Caring for You, Caring for me + Social Worker (EducatiCaregiver Burden6 Month Follow-up22.07 units on a scaleStandard Deviation 7.43
Arm 2: Caring for You, Caring for me + Social Worker (EducatiCaregiver Burden12 Month Follow-up21.57 units on a scaleStandard Deviation 7.69
Arm 3: Control Group Usual CareCaregiver Burden12 Month Follow-up21.06 units on a scaleStandard Deviation 8.18
Arm 3: Control Group Usual CareCaregiver Burden6 Month Follow-up22.65 units on a scaleStandard Deviation 8.29
Arm 3: Control Group Usual CareCaregiver BurdenBaseline23.41 units on a scaleStandard Deviation 8.48
Secondary

Caregiver Efficacy

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

ArmMeasureGroupValue (MEAN)Dispersion
Overall EvaluationCaregiver Efficacy6 Month Follow-up4.15 units on a scaleStandard Deviation 0.47
Overall EvaluationCaregiver EfficacyBaseline4.15 units on a scaleStandard Deviation 0.65
Overall EvaluationCaregiver Efficacy12 Month Follow-up4.09 units on a scaleStandard Deviation 0.52
Arm 2: Caring for You, Caring for me + Social Worker (EducatiCaregiver Efficacy6 Month Follow-up4.18 units on a scaleStandard Deviation 0.52
Arm 2: Caring for You, Caring for me + Social Worker (EducatiCaregiver EfficacyBaseline4.16 units on a scaleStandard Deviation 0.52
Arm 2: Caring for You, Caring for me + Social Worker (EducatiCaregiver Efficacy12 Month Follow-up4.22 units on a scaleStandard Deviation 0.5
Arm 3: Control Group Usual CareCaregiver EfficacyBaseline4.78 units on a scaleStandard Deviation 0.41
Arm 3: Control Group Usual CareCaregiver Efficacy12 Month Follow-up4.17 units on a scaleStandard Deviation 0.47
Arm 3: Control Group Usual CareCaregiver Efficacy6 Month Follow-up4.15 units on a scaleStandard Deviation 0.55
Secondary

Caregiver Mastery

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

ArmMeasureGroupValue (MEDIAN)Dispersion
Overall EvaluationCaregiver MasteryBaseline13.51 units on a scaleStandard Deviation 3.5
Overall EvaluationCaregiver Mastery12 Month Follow-up6.88 units on a scaleStandard Deviation 2.23
Overall EvaluationCaregiver Mastery6 Month Follow-up10.90 units on a scaleStandard Deviation 2.41
Arm 2: Caring for You, Caring for me + Social Worker (EducatiCaregiver MasteryBaseline13.25 units on a scaleStandard Deviation 3.34
Arm 2: Caring for You, Caring for me + Social Worker (EducatiCaregiver Mastery6 Month Follow-up11.21 units on a scaleStandard Deviation 2.13
Arm 2: Caring for You, Caring for me + Social Worker (EducatiCaregiver Mastery12 Month Follow-up7.04 units on a scaleStandard Deviation 1.86
Arm 3: Control Group Usual CareCaregiver MasteryBaseline11.59 units on a scaleStandard Deviation 3.06
Arm 3: Control Group Usual CareCaregiver Mastery12 Month Follow-up6.24 units on a scaleStandard Deviation 2.28
Arm 3: Control Group Usual CareCaregiver Mastery6 Month Follow-up9.59 units on a scaleStandard Deviation 1.73
Secondary

Caregiver Satisfaction

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

ArmMeasureGroupValue (MEAN)Dispersion
Overall EvaluationCaregiver Satisfaction6 Month Follow-up23.02 units on a scaleStandard Deviation 4.64
Overall EvaluationCaregiver Satisfaction12 Month Follow-up22.83 units on a scaleStandard Deviation 4.97
Overall EvaluationCaregiver SatisfactionBaseline23.15 units on a scaleStandard Deviation 4.26
Arm 2: Caring for You, Caring for me + Social Worker (EducatiCaregiver Satisfaction6 Month Follow-up23.43 units on a scaleStandard Deviation 4.98
Arm 2: Caring for You, Caring for me + Social Worker (EducatiCaregiver SatisfactionBaseline23.5 units on a scaleStandard Deviation 5.44
Arm 2: Caring for You, Caring for me + Social Worker (EducatiCaregiver Satisfaction12 Month Follow-up23.50 units on a scaleStandard Deviation 4.81
Arm 3: Control Group Usual CareCaregiver SatisfactionBaseline26.00 units on a scaleStandard Deviation 3.16
Arm 3: Control Group Usual CareCaregiver Satisfaction12 Month Follow-up25.18 units on a scaleStandard Deviation 4.63
Arm 3: Control Group Usual CareCaregiver Satisfaction6 Month Follow-up25.88 units on a scaleStandard Deviation 3.81
Secondary

Depressive Symptoms

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

ArmMeasureGroupValue (MEAN)Dispersion
Overall EvaluationDepressive Symptoms6 Month Follow-up9.27 units on a scaleStandard Deviation 7.96
Overall EvaluationDepressive SymptomsBaseline10.54 units on a scaleStandard Deviation 9.67
Overall EvaluationDepressive Symptoms12 Month Follow-up11.37 units on a scaleStandard Deviation 9.37
Arm 2: Caring for You, Caring for me + Social Worker (EducatiDepressive Symptoms6 Month Follow-up8.29 units on a scaleStandard Deviation 8.07
Arm 2: Caring for You, Caring for me + Social Worker (EducatiDepressive SymptomsBaseline9.96 units on a scaleStandard Deviation 7.97
Arm 2: Caring for You, Caring for me + Social Worker (EducatiDepressive Symptoms12 Month Follow-up7.50 units on a scaleStandard Deviation 7.18
Arm 3: Control Group Usual CareDepressive SymptomsBaseline12.18 units on a scaleStandard Deviation 12.64
Arm 3: Control Group Usual CareDepressive Symptoms12 Month Follow-up11.41 units on a scaleStandard Deviation 9.42
Arm 3: Control Group Usual CareDepressive Symptoms6 Month Follow-up12.47 units on a scaleStandard Deviation 11.79
Secondary

Perceived Social Support

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

ArmMeasureGroupValue (MEAN)Dispersion
Overall EvaluationPerceived Social Support6 Month Follow-up3.65 units on a scaleStandard Deviation 0.76
Overall EvaluationPerceived Social SupportBaseline3.70 units on a scaleStandard Deviation 0.81
Overall EvaluationPerceived Social Support12 Month Follow-up3.72 units on a scaleStandard Deviation 0.81
Arm 2: Caring for You, Caring for me + Social Worker (EducatiPerceived Social Support6 Month Follow-up3.81 units on a scaleStandard Deviation 0.87
Arm 2: Caring for You, Caring for me + Social Worker (EducatiPerceived Social SupportBaseline3.77 units on a scaleStandard Deviation 0.9
Arm 2: Caring for You, Caring for me + Social Worker (EducatiPerceived Social Support12 Month Follow-up3.79 units on a scaleStandard Deviation 0.9
Arm 3: Control Group Usual CarePerceived Social SupportBaseline3.70 units on a scaleStandard Deviation 0.76
Arm 3: Control Group Usual CarePerceived Social Support12 Month Follow-up3.51 units on a scaleStandard Deviation 0.77
Arm 3: Control Group Usual CarePerceived Social Support6 Month Follow-up3.81 units on a scaleStandard Deviation 0.92
Secondary

Personal Mastery

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

ArmMeasureGroupValue (MEAN)Dispersion
Overall EvaluationPersonal Mastery6 Month Follow-up3.64 units on a scaleStandard Deviation 0.76
Overall EvaluationPersonal MasteryBaseline3.60 units on a scaleStandard Deviation 0.73
Overall EvaluationPersonal Mastery12 Month Follow-up3.70 units on a scaleStandard Deviation 0.79
Arm 2: Caring for You, Caring for me + Social Worker (EducatiPersonal Mastery6 Month Follow-up3.90 units on a scaleStandard Deviation 0.77
Arm 2: Caring for You, Caring for me + Social Worker (EducatiPersonal MasteryBaseline3.84 units on a scaleStandard Deviation 0.65
Arm 2: Caring for You, Caring for me + Social Worker (EducatiPersonal Mastery12 Month Follow-up3.89 units on a scaleStandard Deviation 0.76
Arm 3: Control Group Usual CarePersonal MasteryBaseline3.50 units on a scaleStandard Deviation 0.74
Arm 3: Control Group Usual CarePersonal Mastery12 Month Follow-up3.52 units on a scaleStandard Deviation 0.86
Arm 3: Control Group Usual CarePersonal Mastery6 Month Follow-up3.56 units on a scaleStandard Deviation 0.54
Secondary

Physical Function

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

ArmMeasureGroupValue (MEAN)Dispersion
Overall EvaluationPhysical Function12 Month Follow-up2.31 units on a scaleStandard Deviation 0.57
Overall EvaluationPhysical FunctionBaseline2.36 units on a scaleStandard Deviation 0.52
Overall EvaluationPhysical Function6 Month Follow-up2.39 units on a scaleStandard Deviation 0.51
Arm 2: Caring for You, Caring for me + Social Worker (EducatiPhysical Function12 Month Follow-up2.62 units on a scaleStandard Deviation 0.45
Arm 2: Caring for You, Caring for me + Social Worker (EducatiPhysical Function6 Month Follow-up2.64 units on a scaleStandard Deviation 0.41
Arm 2: Caring for You, Caring for me + Social Worker (EducatiPhysical FunctionBaseline2.52 units on a scaleStandard Deviation 0.48
Arm 3: Control Group Usual CarePhysical FunctionBaseline2.58 units on a scaleStandard Deviation 0.4
Arm 3: Control Group Usual CarePhysical Function6 Month Follow-up2.68 units on a scaleStandard Deviation 0.37
Arm 3: Control Group Usual CarePhysical Function12 Month Follow-up1.57 units on a scaleStandard Deviation 0.38
Secondary

Physical Role Function

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

ArmMeasureGroupValue (MEAN)Dispersion
Overall EvaluationPhysical Role FunctionBaseline3.88 units on a scaleStandard Deviation 1.06
Overall EvaluationPhysical Role Function6 Month Follow-up3.90 units on a scaleStandard Deviation 0.98
Overall EvaluationPhysical Role Function12 Month Follow-up3.80 units on a scaleStandard Deviation 0.98
Arm 2: Caring for You, Caring for me + Social Worker (EducatiPhysical Role FunctionBaseline4.33 units on a scaleStandard Deviation 1.01
Arm 2: Caring for You, Caring for me + Social Worker (EducatiPhysical Role Function12 Month Follow-up4.20 units on a scaleStandard Deviation 0.98
Arm 2: Caring for You, Caring for me + Social Worker (EducatiPhysical Role Function6 Month Follow-up4.11 units on a scaleStandard Deviation 0.94
Arm 3: Control Group Usual CarePhysical Role Function6 Month Follow-up4.16 units on a scaleStandard Deviation 0.88
Arm 3: Control Group Usual CarePhysical Role FunctionBaseline3.90 units on a scaleStandard Deviation 0.93
Arm 3: Control Group Usual CarePhysical Role Function12 Month Follow-up4.19 units on a scaleStandard Deviation 0.77
Secondary

Subjective Health

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

ArmMeasureGroupValue (MEAN)Dispersion
Overall EvaluationSubjective HealthBaseline3.49 units on a scaleStandard Deviation 0.83
Overall EvaluationSubjective Health12 month Follow-up3.06 units on a scaleStandard Deviation 0.67
Overall EvaluationSubjective Health6 Month Follow-up3.11 units on a scaleStandard Deviation 0.62
Arm 2: Caring for You, Caring for me + Social Worker (EducatiSubjective HealthBaseline3.68 units on a scaleStandard Deviation 0.77
Arm 2: Caring for You, Caring for me + Social Worker (EducatiSubjective Health6 Month Follow-up3.17 units on a scaleStandard Deviation 0.58
Arm 2: Caring for You, Caring for me + Social Worker (EducatiSubjective Health12 month Follow-up3.19 units on a scaleStandard Deviation 0.72
Arm 3: Control Group Usual CareSubjective HealthBaseline3.37 units on a scaleStandard Deviation 0.64
Arm 3: Control Group Usual CareSubjective Health6 Month Follow-up3.12 units on a scaleStandard Deviation 0.59
Arm 3: Control Group Usual CareSubjective Health12 month Follow-up3.05 units on a scaleStandard Deviation 0.44

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026