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Evaluating the Carter Institute Caregiver Education Program at the VA

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00271375
First received: December 29, 2005
Last updated: April 22, 2016
Last verified: April 2016
Results First Received: October 16, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Factorial Assignment;   Masking: Single Blind (Caregiver);   Primary Purpose: Health Services Research
Condition: Caregivers
Interventions: Behavioral: Caring For You, Caring For Me
Behavioral: Caring for you, caring for me + social worker
Behavioral: Control

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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.
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
Control Group Usual Care Control: Control group usual care

Participant Flow:   Overall Study
    Caring for You, Caring for me Educational Intervention     Caring for You, Caring for me + Social Worker (Educational Int     Control Group Usual Care  
STARTED     114     83     57  
COMPLETED     114     83     57  
NOT COMPLETED     0     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
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.
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
Control Group Usual Care Control: Control group usual care
Total Total of all reporting groups

Baseline Measures
    Caring for You, Caring for me Educational Intervention     Caring for You, Caring for me + Social Worker (Educational Int     Control Group Usual Care     Total  
Number of Participants  
[units: participants]
  114     83     57     254  
Age [1]
[units: Years]
Mean (Standard Deviation)
  66.9  (11.0)     63.4  (11.7)     61.1  (9.8)     64.69  (11.24)  
Gender  
[units: participants]
       
Female     111     76     51     238  
Male     3     7     6     16  
Race (NIH/OMB)  
[units: participants]
       
American Indian or Alaska Native     0     0     0     0  
Asian     0     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0     0  
Black or African American     38     31     24     93  
White     74     52     30     156  
More than one race     0     0     0     0  
Unknown or Not Reported     2     0     3     5  
[1] Age



  Outcome Measures
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1.  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   [ Time Frame: 18 Months ]

2.  Secondary:   Subjective Health   [ Time Frame: Baseline, 6 Month Follow-up, 12 Month Follow-up ]

3.  Secondary:   Physical Role Function   [ Time Frame: Baseline, 6 Month Follow-up, 12 Month Follow-up ]

4.  Secondary:   Physical Function   [ Time Frame: Baseline, 6 Month Follow-up, 12 Month Follow-up ]

5.  Secondary:   Depressive Symptoms   [ Time Frame: Baseline, 6 Month Follow-up, 12 Month Follow-up ]

6.  Secondary:   Caregiver Burden   [ Time Frame: Baseline, 6 Month Follow-up, 12 Month Follow-up ]

7.  Secondary:   Caregiver Satisfaction   [ Time Frame: Baseline, 6 Month Follow-up, 12 Month Follow-up ]

8.  Secondary:   Caregiver Mastery   [ Time Frame: Baseline, 6 Month Follow-up, 12 Month Follow-up ]

9.  Secondary:   Caregiver Efficacy   [ Time Frame: Baseline, 6 Month Follow-up, 12 Month Follow-up ]

10.  Secondary:   Personal Mastery   [ Time Frame: Baseline, 6 Month Follow-up, 12 Month Follow-up ]

11.  Secondary:   Perceived Social Support   [ Time Frame: Baseline, 6 Month Follow-up, 12 Month Follow-up ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Patricia Griffiths
Organization: Atlanta VAMC
phone: 404-321-6111 ext 7138
e-mail: Patricia.Griffiths@va.gov



Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00271375     History of Changes
Other Study ID Numbers: E4044-R
IRB 2005-050240 ( Other Identifier: Atlanta VAMC )
IRB 278-2005 ( Other Identifier: Emory University IRB )
Study First Received: December 29, 2005
Results First Received: October 16, 2014
Last Updated: April 22, 2016
Health Authority: United States: Federal Government