Virtual Patient Behavioral Response Training for Family Caregivers

NCT ID: NCT04489303

Last Updated: 2023-05-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

156 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-15

Study Completion Date

2021-05-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Alzheimer Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Virtual Patient Behavioral Response Training

Caring Response mobile app with a behavioral training.

Group Type EXPERIMENTAL

Caring Response App

Intervention Type BEHAVIORAL

Participants will receive the Caring Response mobile app containing the Virtual Patient Behavioral Response Training.

Educational Training

Traditional educational program.

Group Type ACTIVE_COMPARATOR

Traditional Educational/Resources Program

Intervention Type BEHAVIORAL

Participants will receive a traditional educational/resources program, containing a workbook and online resources.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Caring Response App

Participants will receive the Caring Response mobile app containing the Virtual Patient Behavioral Response Training.

Intervention Type BEHAVIORAL

Traditional Educational/Resources Program

Participants will receive a traditional educational/resources program, containing a workbook and online resources.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Photozig, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Bruno Kajiyama, MS

Role: PRINCIPAL_INVESTIGATOR

Photozig, Inc.

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Photozig, Inc.

Mountain View, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Pz-A107a

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Rural Dementia Caregiver Project
NCT04428112 COMPLETED NA