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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
Sponsor:
Information provided by (Responsible Party):
Photozig, Inc.

Brief Summary:
Our study is designed to help caregivers of someone with Alzheimer's Disease and related dementia to understand and deal with the difficult behaviors of a person with dementia.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Behavioral: Caring Response App Behavioral: Traditional Educational/Resources Program Phase 2

Detailed Description:
The goal of this study is to develop and evaluate the Caring Response mobile app, containing a training that builds skills and stimulates practice. The investigators are evaluating different materials, which may encourage caregiver participation, enable user interaction, and promote better assimilation of concepts. The research team is designing the program to help to enhance caregivers' skills to deal with difficult behaviors, reduce distress, and improve quality of life.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
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


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Care for an individual with Alzheimer's Disease or other dementia.
  • Own a smartphone or tablet and have Internet access.
  • Minimum age of 18 years old.
  • Spend at least 8 hours/week caring for a person with dementia.

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Bruno Kajiyama, MS 6506947595 caring@photozig.com

Locations
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United States, California
Photozig, Inc. Recruiting
Mountain View, California, United States, 94035-0128
Contact: Gerardo Fernandez, BS    650-694-7496 ext 3      
Principal Investigator: Bruno Kajiyama, MS. BS         
Sponsors and Collaborators
Photozig, Inc.
Investigators
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Principal Investigator: Bruno Kajiyama, MS Photozig, Inc.
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Responsible Party: Photozig, Inc.
ClinicalTrials.gov Identifier: NCT04489303    
Other Study ID Numbers: Pz-A107a
First Posted: July 28, 2020    Key Record Dates
Last Update Posted: July 29, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders