Back to resultsVirtual Patient Behavioral Response Training for Family Caregivers
Primary Purpose
Alzheimer Disease
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Caring Response App
Traditional Educational/Resources Program
Sponsored by
About this trial
This is an interventional supportive care trial for Alzheimer Disease
Eligibility 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.
Sites / Locations
- Photozig, Inc.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Virtual Patient Behavioral Response Training
Educational Training
Arm Description
Caring Response mobile app with a behavioral training.
Traditional educational program.
Outcomes
Primary Outcome Measures
Revised Memory and Behavior Problems Checklist
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
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
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04489303
Brief Title
Virtual Patient Behavioral Response Training for Family Caregivers
Official Title
Virtual Patient Behavioral Response Training for Family Caregivers
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
May 15, 2020 (Actual)
Primary Completion Date
May 30, 2021 (Actual)
Study Completion Date
May 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Photozig, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
156 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Virtual Patient Behavioral Response Training
Arm Type
Experimental
Arm Description
Caring Response mobile app with a behavioral training.
Arm Title
Educational Training
Arm Type
Active Comparator
Arm Description
Traditional educational program.
Intervention Type
Behavioral
Intervention Name(s)
Caring Response App
Intervention Description
Participants will receive the Caring Response mobile app containing the Virtual Patient Behavioral Response Training.
Intervention Type
Behavioral
Intervention Name(s)
Traditional Educational/Resources Program
Intervention Description
Participants will receive a traditional educational/resources program, containing a workbook and online resources.
Primary Outcome Measure Information:
Title
Revised Memory and Behavior Problems Checklist
Description
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.
Time Frame
3 months
Title
Center for Epidemiological Studies Depression Scale
Description
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.
Time Frame
3 months
Title
Perceived Stress Scale
Description
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.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruno Kajiyama, MS
Organizational Affiliation
Photozig, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Photozig, Inc.
City
Mountain View
State/Province
California
ZIP/Postal Code
94035-0128
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Virtual Patient Behavioral Response Training for Family Caregivers
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