Virtual Patient Behavioral Response Training for Family Caregivers

Phase 2

Completed

• Conditions: Alzheimer Disease
• Interventions: Behavioral: Traditional Educational/Resources Program; Behavioral: Caring Response App

• Registration Number: NCT04489303
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2020-05-15
• Study First Submitted: 2020-07-24
• Study First Submitted QC: 2020-07-24
• Study First Posted: 2020-07-28
• Primary Completion: 2021-05-30
• Study Completion: 2021-05-30
• Results First Submitted: 2022-05-14
• Status Verified: 2023-05
• Results First Submitted QC: 2023-05-16
• Last Update Submitted: 2023-05-16
• Results First Posted: 2023-05-18
• Last Update Posted: 2023-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 156

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Educational Training	Traditional Educational/Resources Program	Traditional educational program.
Virtual Patient Behavioral Response Training	Caring Response App	Caring Response mobile app with a behavioral training.

Primary Outcome Measures

Name	Time	Method
Revised Memory and Behavior Problems Checklist	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 Stress Scale	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.
Center for Epidemiological Studies Depression Scale	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.

Trial Locations

Locations (1)

Photozig, Inc.; 🇺🇸 Mountain View, California, United States