iCare Stress Management e-Training for Dementia Family Caregivers

This study has been completed.
Sponsor:
Collaborators:
Stanford University
Information provided by (Responsible Party):
Photozig, Inc.
ClinicalTrials.gov Identifier:
NCT01378195
First received: June 17, 2011
Last updated: February 22, 2013
Last verified: February 2013
Results First Received: August 30, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Supportive Care
Conditions: Alzheimer's Disease
Dementia
Interventions: Behavioral: CBT-based program for dementia caregivers
Behavioral: Educational/Resources program

  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
Dates of recruitment period: May 2011 to March 2012

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participant assignment to group was random.

Reporting Groups
  Description
CBT-based CBT-based program (Cognitive Behavioral Therapy) with video, workbook, and website
Educational/Resources Materials Educational/Resources Materials: video, workbook, and website.

Participant Flow:   Overall Study
    CBT-based     Educational/Resources Materials  
STARTED     75     75  
COMPLETED     46     57  
NOT COMPLETED     29     18  
Lost to Follow-up                 29                 18  



  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
CBT-based CBT-based program (Cognitive Behavioral Therapy) with video, workbook, and website
Educational/Resources Materials Educational/Resources Materials: video, workbook, and website.
Total Total of all reporting groups

Baseline Measures
    CBT-based     Educational/Resources Materials     Total  
Number of Participants  
[units: participants]
  75     75     150  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     47     48     95  
>=65 years     28     27     55  
Gender  
[units: participants]
     
Female     59     66     125  
Male     16     9     25  
Region of Enrollment  
[units: participants]
     
United States     75     75     150  



  Outcome Measures
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1.  Primary:   Perceived Stress Scale   [ Time Frame: 3 months ]

2.  Secondary:   Revised Memory and Behavior Problems Checklist   [ Time Frame: 3 months ]

3.  Secondary:   Perceived Quality of Life   [ Time Frame: 3 months ]


  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: Bruno Kajiyama
Organization: Photozig, Inc.
phone: 650-694-7496
e-mail: info@photozig.com


No publications provided


Responsible Party: Photozig, Inc.
ClinicalTrials.gov Identifier: NCT01378195     History of Changes
Other Study ID Numbers: Pz-A103a, R44AG032762
Study First Received: June 17, 2011
Results First Received: August 30, 2012
Last Updated: February 22, 2013
Health Authority: United States: Institutional Review Board