Virtual Patient Behavioral Response Training for Family Caregivers
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|ClinicalTrials.gov Identifier: NCT04489303|
Recruitment Status : Recruiting
First Posted : July 28, 2020
Last Update Posted : July 29, 2020
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer Disease||Behavioral: Caring Response App Behavioral: Traditional Educational/Resources Program||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Virtual Patient Behavioral Response Training for Family Caregivers|
|Actual Study Start Date :||May 15, 2020|
|Estimated Primary Completion Date :||April 30, 2021|
|Estimated Study Completion Date :||May 30, 2021|
Experimental: Virtual Patient Behavioral Response Training
Caring Response mobile app with a behavioral training.
Behavioral: Caring Response App
Participants will receive the Caring Response mobile app containing the Virtual Patient Behavioral Response Training.
Active Comparator: Educational Training
Traditional educational program.
Behavioral: Traditional Educational/Resources Program
Participants will receive a traditional educational/resources program, containing a workbook and online resources.
- 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.
- Center for Epidemiological Studies Depression scale [ Time Frame: 3 months ]The Center for Epidemiological Studies Depression scale (CES-D) is a 20-item measure that asks about the frequency of depressive symptoms (affective, psychological, and somatic) within the past week.The scale refers to the caregiver. Minimum score (best value)=0. Maximum score (worst value)=60. Higher values represent a worse outcome.
- 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.
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): NCT04489303
|Contact: Bruno Kajiyama, MSemail@example.com|
|United States, California|
|Mountain View, California, United States, 94035-0128|
|Contact: Gerardo Fernandez, BS 650-694-7496 ext 3|
|Principal Investigator: Bruno Kajiyama, MS. BS|
|Principal Investigator:||Bruno Kajiyama, MS||Photozig, Inc.|