Ignite Creation Date:
2025-12-24 @ 4:39 PM
Ignite Modification Date:
2026-01-25 @ 2:14 AM
Study NCT ID:
NCT06354166
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-09
First Post:
2024-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Human Digital Support Transitional Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'open-label study'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Interventional, randomised (1:1 ratio), single-centre study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-03', 'studyFirstSubmitDate': '2024-04-03', 'studyFirstSubmitQcDate': '2024-04-03', 'lastUpdatePostDateStruct': {'date': '2024-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'length of stay', 'timeFrame': '1 month', 'description': 'The effectiveness of Divomed in organising complex hospital discharges will be assessed at discharge by comparing lengths of stay in the 2 groups.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Aging']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to compare the effectiveness of Divomed in organising complex hospital discharges with a conventional organisation. Effectiveness will be assessed by reducing the length of stay of patients in geriatric short-stay care.', 'detailedDescription': 'This is an interventional, randomised (ratio 1:1), single-centre, open-label study evaluating Divomed, a digital tool combined with human coordination, to speed up the discharge of people aged over 75 from unscheduled short-stay geriatric hospital admissions to their homes.\n\nThe study population will be patients aged 75 or over, admitted for short term unscheduled geriatric hospitalisation and eligible for discharge home.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '75 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age ≥ 75 years ;\n* Unplanned hospitalisation from emergency, transfers from other inpatient departments or outpatient medicine;\n* Patient eligible for short-stay geriatric hospitalisation estimated to last at least 10 days;\n* Patient eligible for a return home;\n* Patients who have been informed and have signed an informed consent form. If necessary (for cognitive or other reasons), the information must be given to a third party, i.e. the patient's legal representative or trusted person (independent of the investigator and the sponsor), who may be asked to sign or co-sign the informed consent form (depending on the patient's vulnerability).\n\nExclusion Criteria:\n\n* Patients scheduled for transfusion, iron infusion or colonoscopy;\n* Patients in palliative care;\n* Geographical area other than department 37;\n* Planned discharge from hospital to a residential establishment for dependent elderly people or to follow-up and rehabilitation care or long-term care units;\n* Patient or deprived of liberty by judicial or administrative decision ;\n* Patient participating in or being excluded from another clinical trial;\n* Patients not covered by a social security scheme."}, 'identificationModule': {'nctId': 'NCT06354166', 'acronym': 'SUNH-ST', 'briefTitle': 'Study Human Digital Support Transitional Care', 'organization': {'class': 'OTHER', 'fullName': 'Divoluci'}, 'officialTitle': 'Contribution of a Digital Tool Combined With Supportive Human Coordination for Transitional Care of Patients in Unscheduled Hospitalisation in Geriatric Short-stay Care', 'orgStudyIdInfo': {'id': '2023-A02745-40'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Divomed digital tool combined with human coordination', 'description': "A digital tool combined with human coordination (Divomed) to organise discharge home from the start of hospitalisation. The digital application will be interconnected with the patient's medical file.", 'interventionNames': ['Procedure: Unscheduled hospital admissions']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': "The control group corresponds to the organisation of conventional hospital discharge from the geriatric short-stay department.\n\nThe digital application will be interconnected with the patient's medical file.", 'interventionNames': ['Procedure: Unscheduled hospital admissions']}], 'interventions': [{'name': 'Unscheduled hospital admissions', 'type': 'PROCEDURE', 'description': 'Unscheduled short-stay geriatric hospitalisations of people aged over 75 to their homes', 'armGroupLabels': ['Control Group', 'Divomed digital tool combined with human coordination']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37044', 'city': 'Tours', 'country': 'France', 'contacts': [{'name': 'Wassim GANA, MD', 'role': 'CONTACT', 'email': 'w.gana@chu-tours.fr'}], 'facility': 'CHRU de Tours - Hôpital Bretonneau', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}], 'centralContacts': [{'name': 'Wassim GANA', 'role': 'CONTACT', 'email': 'w.gana@chu-tours.fr', 'phone': '247474747', 'phoneExt': '+33'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Divoluci', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}