DementiaPhase 2NCT07115251
Plans4Care: Personalized Dementia Care on Demand
A Phase 2 study testing Plans4Care in people with Dementia and Dementia Alzheimer Type, run by Plans4Care Inc.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Dementia, Dementia Alzheimer Type, Alzheimer Dementia (AD)
- What is being tested?
- Plans4Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- 30 Aug 2025to 30 Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
- 6. Actively (e.g., past 6 months) managing a dementia-related care challenge.
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the detailed description
We invite caregivers of people with dementia to take part in this research study. You are being asked to evaluate a new online application (web app) called Plans4Care that provides personalized action plans to address common dementia-related care challenges including tips for your own health and wellbeing. This study is being conducted by Plans4Care, Inc. and researchers at Drexel University in collaboration with Thomas Jefferson University.
Participants who are eligible for this study are:
- 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.
- Being tested
- Plans4Care
- Keywords
- Caregiver, Dementia, Memory Loss, Alzheimer
- Medical subject headings
- Dementia, Alzheimer Disease, Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plans4CareBehavioural
Also called P4C
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.
| Study group | Role | What they receive |
|---|---|---|
| initial treatment group | Experimental | Receives Plans4Care web app Receives: Behavioral: Plans4Care |
| Waitlist control | Other | At 6 months, receives access to the Plans4Care web app Receives: Behavioral: Plans4Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 3 months, 6 months and 12 months
Secondary outcomes (3)
Caregiver/customer satisfaction (outcome) Net promoter Score
"How likely is it that you would recommend Plans4Care to a friend or colleague?" (0=not at all to 10=extremely likely). Promoters = score 9 or 10; Passives = score 7 or 8. Detractors = score=0 to 6
Measured: 6 months and 12 months
Caregiver satisfaction survey
A questionnaire designed to gauge how satisfied caregivers are with their work, including their work environment, support systems, and overall job satisfaction.
Measured: 6 months and 12 months
Health care utilization
Caregiver report 911 calls, emergency room visits, hospitalizations, nursing home placement for person with AD/ADRD
Electronic records from primary care practices of emergency room visits and days hospitalized
Measured: Baseline, 3 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start30 Aug 2025 (estimated)
- Primary completion30 Aug 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Plans4Care Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Drexel University, Thomas Jefferson University, National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Sokha Koeuth, Plans4Care Inc
- Investigators
- Sokha Koeuth, DHSc, Principal investigator, Plans4Care IncEric Jutkowitz, PhD, Principal investigator, Plans4Care IncLaura N. Gitlin, PhD, FGSA,FAAN, Study director, Drexel UniversityCatherine V Piersol, PhD, OTR/L,FAOTA, FNAP, Study director, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07115251
- Sponsor's protocol ID
- 2306009970
- Other IDs
- 4R44AG084365
- Status last verified
- Aug 2025
- First submitted
- 4 Aug 2025
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plans4Care: Personalized Dementia Care on Demand
- ClinicalTrials.gov ID
- NCT07115251
- Acronym / sponsor ID
- 2306009970
- Keywords
- Caregiver, Dementia, Memory Loss, Alzheimer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Plans4Care IncIndustry (pharma, biotech, devices)
- Collaborators
- Drexel University, Thomas Jefferson University, National Institute on Aging (NIA)
- Study start
- 30 Aug 2025 (estimated)
- Primary completion
- 30 Aug 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 11 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
We invite caregivers of people with dementia to take part in this research study. You are being asked to evaluate a new online application (web app) called Plans4Care that provides personalized action plans to address common dementia-related care challenges including tips for your own health and wellbeing. This study is being conducted by Plans4Care, Inc. and researchers at Drexel University in collaboration with Thomas Jefferson University.
Participants who are eligible for this study are:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| initial treatment group | Experimental | Behavioral: Plans4CareReceives Plans4Care web app |
| Waitlist control | Other | Behavioral: Plans4CareAt 6 months, receives access to the Plans4Care web app |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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;
- 6. Actively (e.g., past 6 months) managing a dementia-related care challenge.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plans4CareAlso: P4CCaregivers 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. | Behavioural | Waitlist control, initial treatment group |
Primary outcome
Caregiver well-being
Time frame: Baseline, 3 months, 6 months and 12 months
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.
3 secondary outcomes
Caregiver/customer satisfaction (outcome) Net promoter Score
Time frame: 6 months and 12 months
Caregiver satisfaction survey
Time frame: 6 months and 12 months
Health care utilization
Time frame: Baseline, 3 months, 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sokha Koeuth, DHSc principal investigator
Plans4Care Inc
Eric Jutkowitz, PhD principal investigator
Plans4Care Inc
Laura N. Gitlin, PhD, FGSA,FAAN study director
Drexel University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Plans4Care in people with Dementia and Dementia Alzheimer Type, run by Plans4Care Inc.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sokha Koeuth, DHSc (12153008483, sokha_koeuth@plans4care.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caregiver well-being (time frame: Baseline, 3 months, 6 months and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025.