Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2025-12-28 @ 8:29 AM
Study NCT ID:
NCT04866550
Status:
UNKNOWN
Last Update Posted:
2022-05-03
First Post:
2021-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Health in Smart Rurality: Impact on Coordination of Care of Telemonitoring and Data Centralization of Frailty Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D002908', 'term': 'Chronic Disease'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003625', 'term': 'Data Collection'}], 'ancestors': [{'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-06-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-02', 'studyFirstSubmitDate': '2021-04-27', 'studyFirstSubmitQcDate': '2021-04-27', 'lastUpdatePostDateStruct': {'date': '2022-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Alert according to the connected tablet', 'timeFrame': '12 months', 'description': 'significant change in temperature (egal or more 38°), weight (variation of more than 5%), heart rate (less than 50 beats per minute or greater than 100), systolic blood pressure (less than 85 mmHg or greater than 160 mmHg) and / or oxygen saturation (variation of more than 4%)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic diseases', 'Aging people', 'Cross-border care', 'New communication technology'], 'conditions': ['Chronic Obstructive Pulmonary Disease', 'Heart Failure']}, 'descriptionModule': {'briefSummary': 'Chronic diseases are frequent (around 10% of the total population and 30% after 60 years) and accelerate age-related functional decline. Concerning cross-border patients, use of health services can be delayed given the distances, the lack of rapid road access and the limited availability of public transport and the complex organization of coordinated care.\n\nOne of the ways to reduce acute exacerbations and preserve the quality of life of patients is to detect warning signs early. One of the ways to do this is to use new communication technologies.', 'detailedDescription': 'The aim of the study is to assess feasibility of using a connected tablet to assess clinical parameters with an alert system in frailty patients aged over 60, living at home, with heart failure and / or chronic obstructive pulmonary disease, potentially requiring care cross-border (France and Belgium).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients aged over 60, living at home, with heart failure and / or chronic obstructive pulmonary disease, potentially requiring care cross-border (France and Belgium).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged over 60\n* Patients living at home\n* Patients with heart failure and / or chronic obstructive pulmonary disease,\n* Patients potentially requiring care cross-border (France and Belgium).\n* Patients agreeing to participate to the study\n\nExclusion Criteria:\n\n* Patients who do not speak French\n* Patients with severe cognitive impairment'}, 'identificationModule': {'nctId': 'NCT04866550', 'acronym': 'HIS2R', 'briefTitle': 'Health in Smart Rurality: Impact on Coordination of Care of Telemonitoring and Data Centralization of Frailty Patients', 'organization': {'class': 'OTHER', 'fullName': 'Université de Reims Champagne-Ardenne'}, 'officialTitle': 'Health in Smart Rurality: Impact on Coordination of Care of Telemonitoring and Data Centralization of Frailty Patients', 'orgStudyIdInfo': {'id': '2020-005-HIS2R'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Connected tablet', 'description': 'Patients aged over 60, living at home, with heart failure and / or chronic obstructive pulmonary disease, potentially requiring care cross-border (France and Belgium).', 'interventionNames': ['Other: Data collection']}], 'interventions': [{'name': 'Data collection', 'type': 'OTHER', 'description': 'Daily record of temperature, weight, heart rate, systolic blood pressure and oxygen saturation', 'armGroupLabels': ['Connected tablet']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Reims', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jean-Luc NOVELLA', 'role': 'CONTACT'}], 'facility': 'Université de Reims Champagne-Ardenne', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}], 'centralContacts': [{'name': 'Jean-Luc NOVELLA', 'role': 'CONTACT', 'email': 'jlnovella@chu-reims.fr', 'phone': '03 26 78 44 10'}], 'overallOfficials': [{'name': 'Jean-Luc NOVELLA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Université de Reims Champagne-Ardenne - CHU de Reims'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Université de Reims Champagne-Ardenne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}