Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2026-01-05 @ 6:05 PM
Study NCT ID:
NCT03263169
Status:
UNKNOWN
Last Update Posted:
2017-08-28
First Post:
2017-08-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Community-based Personalized Care and QOL
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1100}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2018-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-08-23', 'studyFirstSubmitDate': '2017-08-21', 'studyFirstSubmitQcDate': '2017-08-23', 'lastUpdatePostDateStruct': {'date': '2017-08-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of Life', 'timeFrame': 'Baseline and then monthly for 24 months', 'description': 'McGill QoL - patient and family'}, {'measure': 'Perceived health', 'timeFrame': 'Baseline and then monthly for 24 months', 'description': 'EQ-5D-5L - patient'}], 'secondaryOutcomes': [{'measure': 'Caregiver Burden 1', 'timeFrame': 'Baseline and then monthly for 24 months', 'description': 'InterRAI-home care'}, {'measure': 'Caregiver Burden 2', 'timeFrame': 'Baseline and then monthly for 24 months', 'description': 'Zarit burden interview'}, {'measure': 'Patient experience', 'timeFrame': 'Baseline and then monthly for 24 months', 'description': 'CANHelp Patient'}, {'measure': 'Family experience', 'timeFrame': 'Baseline and then monthly for 24 months', 'description': 'CANHelp Family'}, {'measure': 'Symptom management 1', 'timeFrame': 'Baseline and then monthly for 24 months', 'description': 'Edmonton Symptom Assessment Scale'}, {'measure': 'Symptom management 2', 'timeFrame': 'Baseline and then monthly for 24 months', 'description': 'Palliative Performance Scale'}, {'measure': 'Symptom management 3', 'timeFrame': 'Baseline and then monthly for 24 months', 'description': 'InterRAI-home care'}, {'measure': 'Health services utilization 1', 'timeFrame': 'Baseline and then monthly for 24 months', 'description': 'hospitalization'}, {'measure': 'Health services utilization 2', 'timeFrame': 'Baseline and then monthly for 24 months', 'description': 'Emergency care'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['e-health, community networks, pragmatic RCT'], 'conditions': ['Aging', 'Disability or Chronic Disease Leading to Disablement']}, 'descriptionModule': {'briefSummary': 'A pragmatic randomized trial to evaluate the impact of an integrated patient experience and outcome measurement system supported by citizens, caregivers and community through eHealth technology.\n\nThe primary research question is: What is the effectiveness of the WECCC approach on quality of life in people aged 65 and older or who self-identify as disabled compared to people not receiving the Health TAPESTRY program?', 'detailedDescription': 'Secondary research questions include:\n\n1. what is the feasibility of obtaining study measures through routinely collected program participant data and what design adjustments are needed to balance pragmatism and high quality data collection?\n2. What are the analytic approaches to be developed to aggregate data from individual participants into meaningful units (e.g. care-team level, organizational level, social network, and geographic area) to inform ongoing adaptation of the components of the intervention?\n3. what are the perceptions of knowledge users on the usefulness of comparative effectiveness pragmatic trial evidence?\n\nThe project involves using administrative data from the ICES to create outcome measures and feedback systems for communities, and the INSPIRE PHC Unit for expertise in health system integration, care in the community, and knowledge translation.\n\nInclusion criteria: Seniors (65+) and people who self-identify as having a functional disability. Pilot study sites: 7 municipalities and the city of Windsor in Windsor-Essex County in Ontario. The combined total eligible population in all 8 sites is about 60,000 people, from which a minimum sample of 3000 registered patients and 1000 registered caregivers will be drawn\n\nIn Year 1, planned enrolment includes a minimum of 1100 intervention clients from all recruitment methods in the care model intervention, with similar numbers of control and intention to treat clients.\n\nThe primary outcomes are quality of life (QOL); perceived health; experience of care, and perceived social connection.\n\nThe primary outcomes for caregivers will be quality of life; perceived burden; caregiver perceptions of care; and perceived social connection.\n\nSecondary outcomes for both will include goal attainment, distress management, symptom management, places of care, and health care utilization and costs. In terms of health equity, the investigators will measure the difference between the average/median population quality of life and cost outcomes compared to patients at the bottom income quartiles stratified by risk level. At a systems level, algorithms will be developed and applied to the data collected from participants to provide aggregate organization and system-level reports, co-designed with end users to support them as learning organizations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Seniors who identify with having a functional disability or serious chronic disease; and informal caregivers. Many patients within this broad target population will be at risk of worsening quality of life or escalating health care utilization now or in the future due to aging, disease progression, or unmet health, social or economic needs.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nIndividuals who:\n\n1. are 65 years of age and over\n2. have a long-term disability or one or more chronic diseases\n3. able to communicate in English OR can provide a formal or informal translator willing to facilitate the participant's involvement\n\nExclusion Criteria:\n\nIndividuals not meeting above criteria"}, 'identificationModule': {'nctId': 'NCT03263169', 'briefTitle': 'Community-based Personalized Care and QOL', 'organization': {'class': 'OTHER', 'fullName': 'Windsor-Essex Compassionate Care Community'}, 'officialTitle': 'A Pragmatic Trial to Evaluate the Impact of Community-based Personalized Care on Quality of Life in Older and Disabled Adults', 'orgStudyIdInfo': {'id': 'HealthTap-WEPilot'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'WE Health Tapestry', 'description': 'Completion of baseline measures then enrolled in a community-based personalized care intervention that consists of four core elements: volunteer support, interprofessional care, technology, social network linkage', 'interventionNames': ['Behavioral: Community-based personalized care']}, {'label': 'Usual Care', 'description': 'Completion of baseline measures with six-month delayed community-based personalized care intervention: volunteer support, interprofessional care, technology, social network linkage', 'interventionNames': ['Behavioral: Community-based personalized care']}], 'interventions': [{'name': 'Community-based personalized care', 'type': 'BEHAVIORAL', 'description': 'volunteer support, health technology, interprofessional care, social network linkage', 'armGroupLabels': ['Usual Care', 'WE Health Tapestry']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N8T 1B5', 'city': 'Windsor', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Deborah Sattler', 'role': 'CONTACT', 'email': 'deborah@deborahsattler.ca', 'phone': '519-974-2581', 'phoneExt': '2420'}, {'name': 'Diane Halbgewachs', 'role': 'CONTACT', 'email': 'DHalbgewachs2@thehospice.ca', 'phone': '519-974-2581', 'phoneExt': '2420'}, {'name': 'Michelle Howard, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Lisa Dolovich, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Kathryn Pfaff, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Merrick Zwarenstein, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Windsor-Essex Compassionate Care Community Program Management Office', 'geoPoint': {'lat': 42.30008, 'lon': -83.01654}}], 'centralContacts': [{'name': 'Deborah Sattler', 'role': 'CONTACT', 'email': 'deborah@deborahsattler.ca', 'phone': '974-2581', 'phoneExt': '2420'}, {'name': 'Kathryn A Pfaff, PhD', 'role': 'CONTACT', 'email': 'kpfaff@uwindsor.ca', 'phone': '253-3000', 'phoneExt': '4977'}], 'overallOfficials': [{'name': 'Michelle Howard, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'McMaster University'}, {'name': 'Lisa Dolovich, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'McMaster University'}, {'name': 'Kathryn Pfaff, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Windsor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Windsor-Essex Compassionate Care Community', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Windsor', 'class': 'OTHER'}, {'name': 'McMaster University', 'class': 'OTHER'}, {'name': 'University of Western Ontario, Canada', 'class': 'OTHER'}, {'name': 'Green Shield Canada Inc.', 'class': 'INDUSTRY'}, {'name': 'Erie St. Clair Local Health Integration Network (LHIN)', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}