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| ID | Type | Description | Link |
|---|---|---|---|
| IRB 2005-050240 | Other Identifier | Atlanta VAMC | |
| IRB 278-2005 | Other Identifier | Emory University IRB |
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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).
Primary objectives of the research were:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Caring for you, Caring for me Educational Intervention | Experimental | Educational Intervention |
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| Arm 2: Caring for you, caring for me + social worker | Experimental | Educational + Social Work Intervention |
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| Arm 3: Control group usual care | Placebo Comparator | Control group usual care |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Caring For You, Caring For Me | Behavioral | 5-week Education and Support Program for Caregivers of older adults. |
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| 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patricia Griffiths, PhD | Atlanta VAMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Medical Center, Decatur | Decatur | Georgia | 30033 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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 |
| FG002 | Control Group Usual Care | Control: Control group usual care |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Caring for You, Caring for me + Social Worker (Educational Int |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Number | participants | 18 Months |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1: 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Patricia Griffiths | Atlanta VAMC | 404-321-6111 | 7138 | Patricia.Griffiths@va.gov |
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| Caring for you, caring for me + social worker | Behavioral | 5-week Education and Support Program for Caregivers of older adults.+ augmentation with social worker |
|
| Control | Behavioral | Control group usual care |
|
| Baseline, 6 Month Follow-up, 12 Month Follow-up |
| 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). | Baseline, 6 Month Follow-up, 12 Month Follow-up |
| 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). | Baseline, 6 Month Follow-up, 12 Month Follow-up |
| 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). | Baseline, 6 Month Follow-up, 12 Month Follow-up |
| 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). | Baseline, 6 Month Follow-up, 12 Month Follow-up |
| 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). | Baseline, 6 Month Follow-up, 12 Month Follow-up |
| 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). | Baseline, 6 Month Follow-up, 12 Month Follow-up |
| 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). | Baseline, 6 Month Follow-up, 12 Month Follow-up |
| 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). | Baseline, 6 Month Follow-up, 12 Month Follow-up |
| 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). | Baseline, 6 Month Follow-up, 12 Month Follow-up |
Caring for you, caring for me + social worker: 5-week Education and Support Program for Caregivers of older adults.+ augmentation with social worker
| BG002 | Control Group Usual Care | Control: Control group usual care |
| BG003 | Total | Total of all reporting groups |
| Standard Deviation |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| 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). | Posted | Mean | Standard Deviation | units on a scale | Baseline, 6 Month Follow-up, 12 Month Follow-up |
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| 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). | Posted | Mean | Standard Deviation | units on a scale | Baseline, 6 Month Follow-up, 12 Month Follow-up |
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| 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). | Posted | Mean | Standard Deviation | units on a scale | Baseline, 6 Month Follow-up, 12 Month Follow-up |
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| 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). | Posted | Mean | Standard Deviation | units on a scale | Baseline, 6 Month Follow-up, 12 Month Follow-up |
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| 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). | Posted | Mean | Standard Deviation | units on a scale | Baseline, 6 Month Follow-up, 12 Month Follow-up |
|
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| 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). | Posted | Mean | Standard Deviation | units on a scale | Baseline, 6 Month Follow-up, 12 Month Follow-up |
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| 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). | Posted | Median | Standard Deviation | units on a scale | Baseline, 6 Month Follow-up, 12 Month Follow-up |
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| 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). | Posted | Mean | Standard Deviation | units on a scale | Baseline, 6 Month Follow-up, 12 Month Follow-up |
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| 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). | Posted | Mean | Standard Deviation | units on a scale | Baseline, 6 Month Follow-up, 12 Month Follow-up |
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| 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). | Posted | Mean | Standard Deviation | units on a scale | Baseline, 6 Month Follow-up, 12 Month Follow-up |
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| 0 |
| 114 |
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| 114 |
| EG001 | 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 | 0 | 83 | 0 | 83 |
| EG002 | Arm 3: Control Group Usual Care | Control: Control group usual care | 0 | 57 | 0 | 57 |
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