CaregiversNCT00271375
Evaluating the Carter Institute Caregiver Education Program at the VA
A study testing Caring For You, Caring For Me and Caring for you, caring for me + social worker in people with Caregivers, run by VA Office of Research and Development at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Caregivers
- What is being tested?
- Caring For You, Caring For Me and Caring for you, caring for me + social worker
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 254 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2005to Oct 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Caregivers are automatically excluded if veteran has a terminal illness with six months or less to live.
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the detailed description
Primary objectives of the research were:
- 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;
- to assess effects of the program upon psychosocial and physical well-being of informal caregivers over a 1-year period .
- Conditions
- Caregivers
- Being tested
- Caring For You, Caring For Me, Caring for you, caring for me + social worker, Control
- Keywords
- Age, Caregivers, Family, Intervention Studies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caring For You, Caring For MeBehavioural
5-week Education and Support Program for Caregivers of older adults.
Caring for you, caring for me + social workerBehavioural
5-week Education and Support Program for Caregivers of older adults.+ augmentation with social worker
ControlBehavioural
Control group usual care
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Caring for you, Caring for me Educational Intervention | Experimental | Educational Intervention Receives: Behavioral: Caring For You, Caring For Me |
| Arm 2: Caring for you, caring for me + social worker | Experimental | Educational + Social Work Intervention Receives: Behavioral: Caring for you, caring for me + social worker |
| Arm 3: Control group usual care | Placebo comparator | Control group usual care Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 Months
Secondary outcomes (10)
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Baseline, 6 Month Follow-up, 12 Month Follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2005 (estimated)
- Study startOct 2005
- Primary completionAug 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CaregiversStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 254 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Patricia Griffiths, PhD, Principal investigator, Atlanta VAMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00271375
- Sponsor's protocol ID
- E4044-R
- Other IDs
- IRB 2005-050240, IRB 278-2005
- Status last verified
- Apr 2016
- First submitted
- 29 Dec 2005
- Last updated
- 30 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Carter Institute Caregiver Education Program at the VA
- ClinicalTrials.gov ID
- NCT00271375
- Acronym / sponsor ID
- E4044-R
- Conditions
- Caregivers
- Keywords
- Age, Caregivers, Family, Intervention Studies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 254 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Oct 2005
- Primary completion
- Aug 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 30 Dec 2005 (estimated)
- Results
- Posted 30 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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;
- to assess effects of the program upon psychosocial and physical well-being of informal caregivers over a 1-year period .
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- Single blind (care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Caring for you, Caring for me Educational Intervention | Experimental | Behavioral: Caring For You, Caring For MeEducational Intervention |
| Arm 2: Caring for you, caring for me + social worker | Experimental | Behavioral: Caring for you, caring for me + social workerEducational + Social Work Intervention |
| Arm 3: Control group usual care | Placebo comparator | Behavioral: ControlControl group usual care |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Caregivers are automatically excluded if veteran has a terminal illness with six months or less to live.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caring For You, Caring For Me5-week Education and Support Program for Caregivers of older adults. | Behavioural | Arm 1: Caring for you, Caring for me Educational Intervention |
| Caring for you, caring for me + social worker5-week Education and Support Program for Caregivers of older adults.+ augmentation with social worker | Behavioural | Arm 2: Caring for you, caring for me + social worker |
| ControlControl group usual care | Behavioural | Arm 3: Control group usual care |
Primary outcome
To Evaluate User Satisfaction With and Perceived Utility of the "Caring for You, Caring for Me" Caregiver Educational Program Among Formal (VHA Staff) and Informal (Family) Caregivers Who Undergo the Program
Time frame: 18 Months
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.
10 secondary outcomes
Subjective Health
Time frame: Baseline, 6 Month Follow-up, 12 Month Follow-up
Physical Role Function
Time frame: Baseline, 6 Month Follow-up, 12 Month Follow-up
Physical Function
Time frame: Baseline, 6 Month Follow-up, 12 Month Follow-up
Depressive Symptoms
Time frame: Baseline, 6 Month Follow-up, 12 Month Follow-up
Caregiver Burden
Time frame: Baseline, 6 Month Follow-up, 12 Month Follow-up
Caregiver Satisfaction
Time frame: Baseline, 6 Month Follow-up, 12 Month Follow-up
Caregiver Mastery
Time frame: Baseline, 6 Month Follow-up, 12 Month Follow-up
Caregiver Efficacy
Time frame: Baseline, 6 Month Follow-up, 12 Month Follow-up
Personal Mastery
Time frame: Baseline, 6 Month Follow-up, 12 Month Follow-up
Perceived Social Support
Time frame: Baseline, 6 Month Follow-up, 12 Month Follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia Griffiths, PhD principal investigator
Atlanta VAMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caring For You, Caring For Me and Caring for you, caring for me + social worker in people with Caregivers, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To Evaluate User Satisfaction With and Perceived Utility of the "Caring for You, Caring for Me" Caregiver Educational Program Among Formal (VHA Staff) and Informal (Family) Caregivers Who Undergo the Program (time frame: 18 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2016; AzTrials last refreshed its copy on 6 Nov 2026.