iCare Stress Management e-Training for Dementia Family Caregivers - Full Text View

Sponsor:	Photozig, Inc.
Collaborators:	Stanford University National Institute on Aging (NIA)
Information provided by (Responsible Party):	Photozig, Inc.
ClinicalTrials.gov Identifier:	NCT01378195

Purpose

Photozig and Stanford University are creating a program to help cope with caregiving, alleviate related stress, and enhance quality of life for caregivers, with funding from the National Institute on Aging. This home-based program includes a free DVD, printed materials, and resource website. In addition, after completing the program, participants will have free access to final online resources for 1 year. There are no face-to-face meetings, and participants can live anywhere in the United States.

Condition	Intervention	Phase
Alzheimer's Disease Dementia	Behavioral: CBT-based program for dementia caregivers Behavioral: Educational/Resources program	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care
Official Title:	iCare Stress Management e-Training for Dementia Family Caregivers

Resource links provided by NLM:

MedlinePlus related topics: Alzheimer's Caregivers Alzheimer's Disease Caregivers Dementia

U.S. FDA Resources

Further study details as provided by Photozig, Inc.:

Primary Outcome Measures:

Perceived Stress Scale [ Time Frame: 3 months ] [ Designated as safety issue: No ]
This instrument measures overall appraisals of stress in the past month.
Center for Epidemiologic Studies Depression Scale [ Time Frame: 3 months ] [ Designated as safety issue: No ]
This instrument measures the frequency of depressive symptoms.

Secondary Outcome Measures:

Revised Memory and Behavior Problems Checklist [ Time Frame: 3 months ] [ Designated as safety issue: No ]
This instrument assesses troublesome behaviors of care receiver and effect (bother and stress) on caregiver.
Perceived Quality of Life [ Time Frame: 3 months ] [ Designated as safety issue: No ]
This instrument measures quality of life by the evaluation of major categories of fundamental life needs.

Estimated Enrollment:	120
Study Start Date:	May 2011
Estimated Study Completion Date:	March 2012
Estimated Primary Completion Date:	March 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: CBT-based CBT-based program (Cognitive Behavioral Therapy) with video, workbook, and website	Behavioral: CBT-based program for dementia caregivers Participants will receive a CBT-based program [Cognitive Behavioral Therapy], containing videos, workbook, and website.
Active Comparator: Educational/Resources Materials Educational/Resources Materials: video, workbook, and website.	Behavioral: Educational/Resources program Participants will receive a traditional educational/resources program, containing videos, workbook, and website.

Detailed Description:

The goal of this study is to develop the iCare Program, a DVD/online video training that builds skills and stimulates practice. We are evaluating different materials, which may encourage caregiver participation, enable user interaction, and promote better assimilation of concepts. We are designing the program to help to enhance caregivers' skills to deal with demanding tasks of caregiving, alleviate related stress, and improve quality of life.

Research Program Steps:

Caregivers will be asked some simple questions about themselves and their family members to see if they are eligible for the project (fill out Enrollment Form and Informed Consent).
A Program survey will be sent, which can be completed online, or returned in a pre-mailed envelope.
A DVD, materials, link to our website, login information, and instructions will be mailed to participants. We ask participants to watch the DVD, read printed materials, use the website, and follow instructions. Materials are expected to help participants in their caregiver role.
After completing the program, the second and final survey should be filled out online or returned by pre-mailed envelope.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Care for an individual with Alzheimer's Disease or other dementia.
Own a DVD player or have Internet access.
Minimum age of 21 years old.
Spend at least 8 hours/week caring for a person with dementia, which may include assisting, watching, monitoring, or being available to help (e.g. during sleep time).

Exclusion Criteria:

Severe psychological or physical illness.
Inability to read and follow English instructions.
High level of depressive symptoms.
Unwillingness to participate in all aspects of the study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01378195

Locations

United States, California
Photozig, Inc.
Moffett Field, California, United States, 94035-0128

Sponsors and Collaborators

Photozig, Inc.

Stanford University

National Institute on Aging (NIA)

Investigators

Principal Investigator:

Bruno Kajiyama, MS

Photozig, Inc.

More Information

Additional Information:

Dementia Caregiving Program This link exits the ClinicalTrials.gov site

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
Last Updated:	December 10, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Photozig, Inc.:

Alzheimer's Disease
Dementia
caregiving
caregiver

coping
coping with caregiving
stress

Additional relevant MeSH terms:

Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 23, 2012