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

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ClinicalTrials.gov Identifier: NCT01378195
Recruitment Status : Completed
First Posted : June 22, 2011
Results First Posted : January 8, 2013
Last Update Posted : February 28, 2013
Sponsor:
Collaborators:
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
Dementia
Interventions: Behavioral: CBT-based program for dementia caregivers
Behavioral: Educational/Resources program

  Participant Flow

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

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.
No text entered.

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 
Overall Participants Analyzed 
[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

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

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

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

Measure Type Secondary
Measure Title Perceived Quality of Life
Measure Description The "Perceived Quality of Life" (PQoL instrument) measures quality of life by the evaluation of major categories of fundamental life needs. This measure was developed using a normative sample of older individuals, and has been used in a number of studies investigating the effects of chronic disorders on the perceived quality of life. The scale contains items describing level of satisfaction with needs and resources in various categories. The scale refers to the caregiver. Minimum (worst value) = 0. Maximum score (best value=10. Higher values represent a better outcome.
Time Frame 3 months  

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.
No text entered.

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.

Measured Values
   CBT-based   Educational/Resources Materials 
Participants Analyzed 
[Units: Participants]
 		 46   57 
Perceived Quality of Life 
[Units: Units on a scale]
Mean (Standard Deviation) 		 6.34  (1.54)   6.31  (1.84) 

No statistical analysis provided for Perceived Quality of Life




  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
No text entered.


  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
e-mail: info@photozig.com



Responsible Party: Photozig, Inc.
ClinicalTrials.gov 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