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
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer's Disease Dementia||Behavioral: CBT-based program for dementia caregivers Behavioral: Educational/Resources program||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||iCare Stress Management e-Training for Dementia Family Caregivers|
|Study Start Date :||May 2011|
|Actual Primary Completion Date :||July 2012|
|Actual Study Completion Date :||July 2012|
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.
- Perceived Stress Scale [ Time Frame: 3 months ]The "Perceived Stress Scale" measures the overall level of stress. This instrument contains 10 items accessing overall appraisals of stress in the past month. The scale refers to the caregiver. Minimum score (best value)=0. Maximum score (worst value)=40. Higher values represent a worse outcome.
- Revised Memory and Behavior Problems Checklist [ Time Frame: 3 months ]This scale measures the type/number of dementia patients disturbing behaviors, and how much they bother caregivers with 24 items describing possible troublesome behaviors that the patient might evidence in the past month. Caregivers are first asked whether the dementia patient had displayed any of these in the time period, and secondly to rate on a 5-point scale (0=not at all; 4= extremely) how much this "bothered or upset" them. A "conditional bother" score is calculated which is the "upset" or "bother" ratings for only the problematic behavior that occurred. The scale refers to the caregiver. Minimum score (best value)=0. Maximum score (worst value)=4. Higher values represent a worse outcome.
- Perceived Quality of Life [ Time Frame: 3 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01378195
|United States, California|
|Moffett Field, California, United States, 94035-0128|
|Principal Investigator:||Bruno Kajiyama, MS||Photozig, Inc.|