Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2026-01-02 @ 2:20 AM
Study NCT ID:
NCT07115251
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-11
First Post:
2025-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Plans4Care: Personalized Dementia Care on Demand
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D000544', 'term': 'Alzheimer Disease'}, {'id': 'D008569', 'term': 'Memory Disorders'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-04', 'studyFirstSubmitDate': '2025-08-04', 'studyFirstSubmitQcDate': '2025-08-04', 'lastUpdatePostDateStruct': {'date': '2025-08-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-08-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Caregiver well-being', 'timeFrame': 'Baseline, 3 months, 6 months and 12 months', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Caregiver/customer satisfaction (outcome) Net promoter Score', 'timeFrame': '6 months and 12 months', 'description': '"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'}, {'measure': 'Caregiver satisfaction survey', 'timeFrame': '6 months and 12 months', 'description': 'A questionnaire designed to gauge how satisfied caregivers are with their work, including their work environment, support systems, and overall job satisfaction.'}, {'measure': 'Health care utilization', 'timeFrame': 'Baseline, 3 months, 12 months', 'description': 'Caregiver report 911 calls, emergency room visits, hospitalizations, nursing home placement for person with AD/ADRD\n\nElectronic records from primary care practices of emergency room visits and days hospitalized'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Caregiver, Dementia, Memory Loss, Alzheimer'], 'conditions': ['Dementia', 'Dementia Alzheimer Type', 'Alzheimer Dementia (AD)', 'Memory Loss']}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.', 'detailedDescription': '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.\n\nParticipants who are eligible for this study are:\n\n1. A family, friend, or neighbor who self-identifies as having primary care responsibilities for a person with memory loss;\n2. \\>21 years of age;\n3. Able to use an internet capable device (computer, tablet or smart phone), and have stable internet access;\n\n6\\. Actively (e.g., past 6 months) managing a dementia-related care challenge.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. A family, friend, or neighbor who self-identifies as having primary care responsibilities for a person with memory loss;\n2. \\>21 years of age;\n3. Able to use an internet capable device (computer, tablet or smart phone), and have stable internet access;\n\n6\\. Actively (e.g., past 6 months) managing a dementia-related care challenge.'}, 'identificationModule': {'nctId': 'NCT07115251', 'briefTitle': 'Plans4Care: Personalized Dementia Care on Demand', 'organization': {'class': 'INDUSTRY', 'fullName': 'Plans4Care Inc'}, 'officialTitle': 'Plans4Care: Personalized Dementia Care on Demand', 'orgStudyIdInfo': {'id': '2306009970'}, 'secondaryIdInfos': [{'id': '4R44AG084365', 'link': 'https://reporter.nih.gov/quickSearch/4R44AG084365', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'initial treatment group', 'description': 'Receives Plans4Care web app', 'interventionNames': ['Behavioral: Plans4Care']}, {'type': 'OTHER', 'label': 'Waitlist control', 'description': 'At 6 months, receives access to the Plans4Care web app', 'interventionNames': ['Behavioral: Plans4Care']}], 'interventions': [{'name': 'Plans4Care', 'type': 'BEHAVIORAL', 'otherNames': ['P4C'], 'description': '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.', 'armGroupLabels': ['Waitlist control', 'initial treatment group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Sokha Koeuth, DHSc', 'role': 'CONTACT', 'email': 'sokha_koeuth@plans4care.com', 'phone': '12153008483'}, {'name': 'Eric Jutkowitz, PhD', 'role': 'CONTACT', 'email': 'eric_jutkowitz@plans4care.com', 'phone': '215-421-9728'}], 'overallOfficials': [{'name': 'Sokha Koeuth, DHSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Plans4Care Inc'}, {'name': 'Eric Jutkowitz, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Plans4Care Inc'}, {'name': 'Laura N. Gitlin, PhD, FGSA,FAAN', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Drexel University'}, {'name': 'Catherine V Piersol, PhD, OTR/L,FAOTA, FNAP', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Thomas Jefferson University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Plans4Care Inc', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Drexel University', 'class': 'OTHER'}, {'name': 'Thomas Jefferson University', 'class': 'OTHER'}, {'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MPI', 'investigatorFullName': 'Sokha Koeuth', 'investigatorAffiliation': 'Plans4Care Inc'}}}}