Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2026-01-06 @ 11:07 AM
Study NCT ID:
NCT06638060
Status:
RECRUITING
Last Update Posted:
2025-05-07
First Post:
2024-09-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Continuous Connected Patient Care (CCPC), a Pilot Testing a Novel Device for Continuous Vitals Monitoring - Older Adults Department PHC
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': 15}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-12-21', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-06', 'studyFirstSubmitDate': '2024-09-16', 'studyFirstSubmitQcDate': '2024-10-09', 'lastUpdatePostDateStruct': {'date': '2025-05-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Collect patient and clinicians' feedback about the CCPC Platform", 'timeFrame': 'From enrollment to the end of follow up at 10 days', 'description': 'This will be completed via an assessment of the quantitative data on how long and how often patients use this monitoring and what were the reasons that patients took the monitors on and off.'}, {'measure': "Collect patient and clinicians' feedback about the CCPC Platform", 'timeFrame': 'From enrollment to the end of follow up at 10 days', 'description': 'This will be completed via an assessment of the Usability Questionnaire.'}, {'measure': "Collect patient and clinicians' feedback about the CCPC Platform", 'timeFrame': 'From enrollment to the end of follow up at 10 days', 'description': 'This will be completed by an evaluation for potential harm, e.g. anxiety questionnaire and any patient-reported adverse events.'}, {'measure': 'Confirm the technical goals of the CCPC platform are met.', 'timeFrame': 'From enrollment to the end of follow up at 10 days', 'description': 'This will be completed by ensuring clinician workflow is met, via feedback sessions (e.g. conversations, questionnaires).'}, {'measure': 'Confirm the technical goals of the CCPC platform are met.', 'timeFrame': 'From enrollment to the end of follow up at 10 days', 'description': 'This will be completed via an assessment of the data flow: does the correct patient data reach the clinicians at the right time?'}, {'measure': 'Confirm the technical goals of the CCPC platform are met.', 'timeFrame': 'From enrollment to the end of follow up at 10 days', 'description': 'This will be completed by determining if the CCPC platform provided a holistic view of each patient with vitals, medication, labs and other collected data.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Aging']}, 'descriptionModule': {'briefSummary': 'To confirm feasibility and accessibility of the CCPC Platform (Oxymotion, Bridge Health Solutions medication adherence software, CloudDX home kit) in two different environments - 1) hospital (Acute Care for Elderly Unit) and 2) at-home .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The Acute Care for Elderly Unit at SPH for 40 inpatients over the age of 65.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inpatients on the Acute care of the Elderly ward.\n\nExclusion Criteria:\n\n* Lack of capacity to consent to the study including moderate-severe dementia or delirium\n* Unable to use (or does not have a caregiver who can help put on) study monitoring device at home\n* Unable to complete (or does not have a caregiver who can help complete) study questionnaires by electronic (mobile, tablet, or computer), paper, nor phone\n* Patient with known allergic reactions to any part material of the device\n* People under 40kg'}, 'identificationModule': {'nctId': 'NCT06638060', 'briefTitle': 'Continuous Connected Patient Care (CCPC), a Pilot Testing a Novel Device for Continuous Vitals Monitoring - Older Adults Department PHC', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic - MITG'}, 'officialTitle': 'Continuous Connected Patient Care (CCPC), a Pilot Testing a Novel Device for Continuous Vitals Monitoring - Older Adults Department PHC', 'orgStudyIdInfo': {'id': 'H24-00744'}}, 'contactsLocationsModule': {'locations': [{'zip': 'V6Z 1Y6', 'city': 'Vancouver', 'state': 'British Columbia', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Janet Kow, MD', 'role': 'CONTACT', 'email': 'jkow@providencehealth.bc.ca'}, {'name': 'Janet Kow, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'St. Paul'sHospital', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'centralContacts': [{'name': 'Elise Huisman', 'role': 'CONTACT', 'email': 'elise.huisman@medtronic.com', 'phone': '+1 236-308-4876'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic - MITG', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Excelar', 'class': 'UNKNOWN'}, {'name': 'Cloud DX Inc.', 'class': 'INDUSTRY'}, {'name': 'Bridge Health Solutions', 'class': 'UNKNOWN'}, {'name': 'Providence Healthcare', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}