NCT00271375

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
254

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 29, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 30, 2005

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
6.7 years until next milestone

Results Posted

Study results publicly available

May 30, 2016

Completed
Last Updated

May 30, 2016

Status Verified

April 1, 2016

Enrollment Period

3.8 years

First QC Date

December 29, 2005

Results QC Date

October 16, 2014

Last Update Submit

April 22, 2016

Conditions

Caregivers

Keywords

AgeCaregiversFamilyIntervention Studies

Outcome Measures

Primary Outcomes (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.

    18 Months

Secondary Outcomes (10)

  • Subjective Health

    Baseline, 6 Month Follow-up, 12 Month Follow-up

  • Physical Role Function

    Baseline, 6 Month Follow-up, 12 Month Follow-up

  • Physical Function

    Baseline, 6 Month Follow-up, 12 Month Follow-up

  • Depressive Symptoms

    Baseline, 6 Month Follow-up, 12 Month Follow-up

  • Caregiver Burden

    Baseline, 6 Month Follow-up, 12 Month Follow-up

  • +5 more secondary outcomes

Study Arms (3)

Arm 1: Caring for you, Caring for me Educational Intervention

EXPERIMENTAL

Educational Intervention

Behavioral: Caring For You, Caring For Me

Arm 2: Caring for you, caring for me + social worker

EXPERIMENTAL

Educational + Social Work Intervention

Behavioral: Caring for you, caring for me + social worker

Arm 3: Control group usual care

PLACEBO COMPARATOR

Control group usual care

Behavioral: Control

Interventions

Caring For You, Caring For MeBEHAVIORAL

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

Arm 1: Caring for you, Caring for me Educational Intervention
Caring for you, caring for me + social workerBEHAVIORAL

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

Arm 2: Caring for you, caring for me + social worker
ControlBEHAVIORAL

Control group usual care

Arm 3: Control group usual care

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Caregivers are automatically excluded if veteran has a terminal illness with six months or less to live.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Medical Center, Decatur

Decatur, Georgia, 30033, United States

Location

Results Point of Contact

Title
Patricia Griffiths
Organization
Atlanta VAMC
Patricia.Griffiths@va.gov
404-321-6111

Study Officials

  • Patricia Griffiths, PhD

    Atlanta VAMC

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
FACTORIAL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 29, 2005

First Posted

December 30, 2005

Study Start

October 1, 2005

Primary Completion

August 1, 2009

Study Completion

October 1, 2009

Last Updated

May 30, 2016

Results First Posted

May 30, 2016

Record last verified: 2016-04

Locations

US(1)