NCT04489303

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
156

participants targeted

Target at P50-P75 for phase_2 alzheimer-disease

Timeline
Completed

Started May 2020

Shorter than P25 for phase_2 alzheimer-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 15, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 24, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 28, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2021

Completed
2 years until next milestone

Results Posted

Study results publicly available

May 18, 2023

Completed
Last Updated

May 18, 2023

Status Verified

May 1, 2023

Enrollment Period

1 year

First QC Date

July 24, 2020

Results QC Date

May 14, 2022

Last Update Submit

May 16, 2023

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (3)

  • 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.

    3 months

  • 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.

    3 months

  • 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.

    3 months

Study Arms (2)

Virtual Patient Behavioral Response Training

EXPERIMENTAL

Caring Response mobile app with a behavioral training.

Behavioral: Caring Response App

Educational Training

ACTIVE COMPARATOR

Traditional educational program.

Behavioral: Traditional Educational/Resources Program

Interventions

Caring Response AppBEHAVIORAL

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

Virtual Patient Behavioral Response Training
Traditional Educational/Resources ProgramBEHAVIORAL

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

Educational Training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Photozig, Inc.

Mountain View, California, 94035-0128, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Results Point of Contact

Title
Bruno Kajiyama
Organization
Photozig, Inc.
info@photozig.com
6506947496

Study Officials

  • Bruno Kajiyama, MS

    Photozig, Inc.

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2020

First Posted

July 28, 2020

Study Start

May 15, 2020

Primary Completion

May 30, 2021

Study Completion

May 30, 2021

Last Updated

May 18, 2023

Results First Posted

May 18, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)