NCT07115251

Brief Summary

The Plans4Care study is a research study funded by the National Institute on Aging (Grant# R44AG084365). The Plans4Care app is designed to help family caregivers address over 90 common care challenges such as behavioral symptoms (anxiety, agitation), functional changes and other concerns, and receive an action plan which provides easy-to-use non-drug strategies, resources, tips and education. The goal of the study is to evaluate whether using the Plans4Care app will help you feel more confident providing care to your family member with dementia, better understand dementia, and enhance your own well-being. You also have the option to talk with a care advisor who can practice use of strategies or address concerns you may have.

Trial Health

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Monitor

Trial Health Score

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

Enrollment
160

participants targeted

Target at P75+ for phase_2

Timeline
17mo left

Started Aug 2025

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress33%
Aug 2025Sep 2027

First Submitted

Initial submission to the registry

August 4, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 11, 2025

Completed
19 days until next milestone

Study Start

First participant enrolled

August 30, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2027

Last Updated

August 11, 2025

Status Verified

August 1, 2025

Enrollment Period

2 years

First QC Date

August 4, 2025

Last Update Submit

August 4, 2025

Conditions

Keywords

Caregiver, Dementia, Memory Loss, Alzheimer

Outcome Measures

Primary Outcomes (1)

  • Caregiver well-being

    13-item validated Perceived Change for Better Index assesses caregiver perceived change (gotten worse-a little/a lot, stayed the same, improved-a little/a lot) in affect, somatic, manage daily care.

    Baseline, 3 months, 6 months and 12 months

Secondary Outcomes (3)

  • Caregiver/customer satisfaction (outcome) Net promoter Score

    6 months and 12 months

  • Caregiver satisfaction survey

    6 months and 12 months

  • Health care utilization

    Baseline, 3 months, 12 months

Study Arms (2)

initial treatment group

EXPERIMENTAL

Receives Plans4Care web app

Behavioral: Plans4Care

Waitlist control

OTHER

At 6 months, receives access to the Plans4Care web app

Behavioral: Plans4Care

Interventions

Plans4CareBEHAVIORAL

Caregivers assigned to treatment condition will receive: 1) access to the web-app; 2) an orientation to the web-app involving initial set up; and 3) a brief video explaining use of the web-app. Caregivers will be guided through accessing the platform, creating an account and completing a brief set of background questions.

Also known as: P4C
Waitlist controlinitial treatment group

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A family, friend, or neighbor who self-identifies as having primary care responsibilities for a person with memory loss;
  • \>21 years of age;
  • Able to use an internet capable device (computer, tablet or smart phone), and have stable internet access;
  • \. Actively (e.g., past 6 months) managing a dementia-related care challenge.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

DementiaAlzheimer DiseaseMemory Disorders

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersTauopathiesNeurodegenerative DiseasesNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Sokha Koeuth, DHSc

    Plans4Care Inc

    PRINCIPAL INVESTIGATOR
  • Eric Jutkowitz, PhD

    Plans4Care Inc

    PRINCIPAL INVESTIGATOR
  • Laura N. Gitlin, PhD, FGSA,FAAN

    Drexel University

    STUDY DIRECTOR
  • Catherine V Piersol, PhD, OTR/L,FAOTA, FNAP

    Thomas Jefferson University

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: This is a non-drug intervention that provides caregivers of people with dementia education and actionable non-drug strategies. Caregivers also have access to speak with a care advisor for additional tele-support.
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MPI

Study Record Dates

First Submitted

August 4, 2025

First Posted

August 11, 2025

Study Start

August 30, 2025

Primary Completion (Estimated)

August 30, 2027

Study Completion (Estimated)

September 30, 2027

Last Updated

August 11, 2025

Record last verified: 2025-08