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Completed

NCT Number: NCT04489303

Virtual Patient Behavioral Response Training for Family Caregivers

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.

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Photozig, Inc.

Mountain View, California, 94035-0128, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Caring Response App

Behavioral

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

Traditional Educational/Resources Program

Behavioral

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

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Photozig, Inc.

Industry

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 28, 2020
Registry last updated
May 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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