iCare Stress Management e-Training for Dementia Family Caregivers (iCare)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01378195
Recruitment Status : Completed
First Posted : June 22, 2011
Results First Posted : January 8, 2013
Last Update Posted : February 28, 2013
Stanford University
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Photozig, Inc.

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Conditions: Alzheimer's Disease
Interventions: Behavioral: CBT-based program for dementia caregivers
Behavioral: Educational/Resources program

  Participant Flow

  Baseline Characteristics

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
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 
Overall Participants Analyzed 
[Units: Participants]
 75   75   150 
[Units: Participants]
<=18 years   0   0   0 
Between 18 and 65 years   47   48   95 
>=65 years   28   27   55 
[Units: Participants]
Female   59   66   125 
Male   16   9   25 
Region of Enrollment 
[Units: Participants]
United States   75   75   150 

  Outcome Measures

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

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

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

Responsible Party: Photozig, Inc. Identifier: NCT01378195     History of Changes
Other Study ID Numbers: Pz-A103a
R44AG032762 ( U.S. NIH Grant/Contract )
First Submitted: June 17, 2011
First Posted: June 22, 2011
Results First Submitted: August 30, 2012
Results First Posted: January 8, 2013
Last Update Posted: February 28, 2013