Virtual Patient Behavioral Response Training for Family Caregivers
Phase: PHASE2
Conditions: Alzheimer Disease
Sponsor: Photozig, Inc.

1 
 
 
 
 
 
 
 
Trial: 
Virtual Patient Behavioral Response 
Training for Family Caregivers 
 
ClinicalTrials.gov ID: 
 
NCT04489303   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Date:  
 
05/13/2022 (updated) 
 
 
Investigator: 
Bruno Kajiyama 
 
 
Research Site: 
 
 
 
 
Photozig, Inc. 
 
 
 
NASA Research Park 
 
 
 
PO Box 128 
 
 
 
Moffett Field, CA 94035-0128 
 

2 
 
Project Summary 
 
The main cause of behavioral symptoms in patients with Alzheimer's disease (AD) is the deterioration 
of brain cells which causes a decline in the individual's ability to make sense of the world. Coping with 
such difficult behaviors is challenging for many caregivers, and it is associated with many distressful 
situations.  
 
The stress of dementia caregiving is influenced by several factors, such as severity of dementia 
symptoms, how challenging distressful situations are perceived by caregivers, and available 
resources. Although information and programs about dementia are available to the public, an 
essential missing tool is how to deal with difficult behaviors of dementia patients in an effective 
manner, as they are very common and demanding. 
 
The goal of this project is to develop the Virtual Patient Behavioral Response (VPBR) training to 
improve skills on how to respond to dementia behavioral problems and enhance caregiver coping. 
We will implement this training in a mobile app (Caring Response App, CRA). The expected benefits 
include improved psychological health in caregivers and reduced stress related to behavioral 
disturbances of AD patients. 
 
 
 
 

3 
 
Protocol 
 
Overview: 
1. Recruit subjects: caregivers of individuals with Alzheimer’s Disease or other dementia will be 
recruited. 
2. Randomize subjects: participants will be assigned to the study group or the control group. 
3. Collect pre-data: Before intervention, we will collect pre-data to establish the baseline status of 
participants. 
4. Deploy treatments: For both study and control groups, we will send instructions and materials. 
5. Collect post-data: We will collect post-treatment data after 3 months. 
 
Research Participants: 150 dementia family caregivers (planned enrollment) will be recruited: 
 
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. 
 
Informed consent will be obtained, and participants will receive a stipend for their participation. 
 
Methods: The effectiveness investigation of the Caring Response App (CRA) will be implemented 
with a pre-post randomized trial of 3 months. As it takes 3 months to complete the entire program, 
post testing will happen about 3 months after pre-testing. The trial will have two levels: the CRA 
treatment package; and a control condition comprised of existing educational programs, information 
for caregivers, and other resources. Outcome measures of both groups will be recorded at baseline 
and after 3 months.  
 
 CRA Condition (75 subjects): Participants will receive the Caring Response mobile app 
containing the coping skills training. 
 
 Control Condition (75 subjects): Participants will receive a traditional educational/resources 
program, containing a workbook and online resources. 
 
Procedures: Participants will receive and complete informed consent. After initial assessment, 
subjects will be randomized to either CRA or the control condition, instructions will be distributed. 
After 3 months, all subjects will be interviewed for the post-intervention assessment. 
 

4 
 
Statistical Analysis Plan 
 
Main study hypothesis: “CRA will contribute to lower burden of care (RMBPC), alleviate depression 
(measured by CES-D), and decrease stress (measured by PSS).” 
 
Main Outcome Measures: 
 Burden of care: level of bother or stress due to disruptive behaviors: we will apply the Revised 
Memory and Behavior Problems Checklist (RMBPC), with 24 items describing possible troublesome 
behaviors of care receiver and effect (bother and stress) on caregiver. 
 Depression: level of Depressive Symptoms: their presence and strength will be assessed using the 
Center for Epidemiological Studies Depression scale (CES-D); This is a 20-item measure that asks 
about the frequency of depressive symptoms (affective, psychological, and somatic) within the past 
week. 
 Overall Perceived Psychological Stress: the 10-item Perceived Stress Scale (PSS) measures 
overall appraisals of stress in the past month. 
 
Analysis: Our hypotheses will be tested by analyzing the change scores (subtracting the baseline 
scores from the value obtained at 3 months) for the outcome measures (RMBPC, CES-D, and PSS), 
and comparing the results of CRA with the control condition in order to determine the efficacy of the 
intervention. We will determine if subjects in CRA had a significant decrease in level of burden, 
reduced depression, and decreased stress, when compared to the control group. We’ll use univariate 
ANOVA (analysis of variance) to determine the level of significance for these measures.