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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

United States1 site
  • VA Medical Center, Decatur

    Decatur, Georgia, 30033

Other trials in United States

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:

  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 .
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 groups in NCT00271375
Study groupRoleWhat they receive
Arm 1: Caring for you, Caring for me Educational InterventionExperimentalEducational Intervention
Receives: Behavioral: Caring For You, Caring For Me
Arm 2: Caring for you, caring for me + social workerExperimentalEducational + Social Work Intervention
Receives: Behavioral: Caring for you, caring for me + social worker
Arm 3: Control group usual carePlacebo comparatorControl group usual care
Receives: Behavioral: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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.

  1. First posted30 Dec 2005 (estimated)
  2. Study startOct 2005
  3. Primary completionAug 2009
  4. Study completionOct 2009

Resources

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)
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
Data monitoring committee
No

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.

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