Ignite Creation Date:
2025-12-24 @ 7:57 PM
Ignite Modification Date:
2025-12-29 @ 11:43 PM
Study NCT ID:
NCT06735404
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-12
First Post:
2024-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
RAPIDE: The Feasibility of a Hybrid Care Model
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-11', 'studyFirstSubmitDate': '2024-12-06', 'studyFirstSubmitQcDate': '2024-12-11', 'lastUpdatePostDateStruct': {'date': '2025-09-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-12-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Acceptability and feasibility from the perspective of patients, informal caregivers, and healthcare professionals, using observations and interviews', 'timeFrame': 'Six and twelve months after enrolment.', 'description': 'Through observations and interviews, the investigators will evaluate the extent to which the hybrid care model is acceptable and feasible for patients, informal care givers, and healthcare professionals.'}, {'measure': 'Implementation feasibility, using observations and interviews', 'timeFrame': 'Six and twelve months after enrolment.', 'description': 'Through observations and interviews, the investigators will evaluate the extent to which the new hybrid care model is practically feasible to implement (facilitators and barriers of implementation).'}, {'measure': 'Changes in practice organisation and care delivery, using observations and interviews', 'timeFrame': 'Six and twelve months after enrolment.', 'description': 'Through observations and interviews, the investigators will evaluate the extent to which the new hybrid care model initiates changes in practice organisation and care delivery.'}], 'primaryOutcomes': [{'measure': 'The impact of the hybrid care model on patient reported experiences (PREMs) and patient reported outcomes (PROMs), using the PaRIS questionnaire.', 'timeFrame': 'At enrolment, at six months after enrolment, and at twelve months after enrolment.'}], 'secondaryOutcomes': [{'measure': 'Episodes of care consumption, using patient chart reviews', 'timeFrame': 'At baseline and 12 months after enrolment'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Type 2', 'Heart Failure']}, 'descriptionModule': {'briefSummary': 'Rationale: During cross-border health emergencies, such as seen with the COVID-19 pandemic, health and care services are rapidly being overwhelmed by high numbers of patients requiring care, leading to stretches in the whole healthcare system. Delays and backlogs in regular care, as the result of the stretched health care services, leave millions of patients with regular care needs unattended, resulting in disastrous healthcare outcomes. If disastrous healthcare outcomes across the population are to be avoided, healthcare systems must become more robust, resilient, and flexible in the face of future health emergencies and allow for rapid changes in the care delivery services.\n\nObjective: To evaluate the feasibility of delivering a hybrid care model alongside care as usual through observations, and questionnaires and interviews on patient reported views, opinions, and experiences. This hybrid care model aims to reduce the burden on health and care systems during a health emergency, decrease the need to scale down regular care, and ensure patient safety and quality of care.\n\nStudy design: One year cohort study, using observations, questionnaires, and interviews.\n\nStudy population: Patients with type 2 diabetes and/or chronic heart failure with comorbidities and/or having a high care consumption according to the treating general practitioner.\n\nIntervention: The hybrid care model will consist of a combination of digital tools and/or task shifting of certain healthcare providers. Examples are:\n\n* Telemonitoring: patients perform self-measurements through e.g. sensors, wearables, or (mobile) applications to get insight in their health status (supporting self-management) and report this to their healthcare provider(s), when relevant\n* Teleconsultation: patients communicate with their healthcare provider(s) remotely\n* Personal health portals and self-management applications\n* Online prescription requests: patients request prescription online Main study parameters/endpoints: The impact of the hybrid care model on patient reported experiences (PREMs) and patient reported outcomes (PROMs).\n\nNature and extent of the burden and risks associated with participation, benefit and group relatedness: Evaluating the feasibility of this hybrid care model will only be done through observations, questionnaires, and interviews at home (during three home visits at baseline, after six months, and after one year). No invasive (physical) procedures will be performed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nIn order to be eligible to participate in this study, a subject must meet all of the following criteria:\n\nPatients with type 2 diabetes mellitus, WITH:\n\n* At least 2 different types of chronic comorbidities (as defined in the list of chronic comorbidities); AND\n* A high number of medical consultations at the GP practice and/or referrals to the hospital in the last 24 months, as identified by the clinical expertise of the treating GP.\n\nPatients with chronic heart failure, WITH:\n\n* At least 2 different types of chronic comorbidities (as defined in the list of chronic comorbidities); AND\n* A high number of medical consultations at the GP practice and/or referrals to the hospital in the last 24 months, as identified by the clinical expertise of the treating GP.\n\nExclusion Criteria:\n\n* Terminally ill patients\n* Comorbidity of a severe psychiatric disorder (i.e. psychosis-related disorders, dementia, and bipolar disorder)\n* Patients who are cognitively impaired'}, 'identificationModule': {'nctId': 'NCT06735404', 'briefTitle': 'RAPIDE: The Feasibility of a Hybrid Care Model', 'organization': {'class': 'OTHER', 'fullName': 'Radboud University Medical Center'}, 'officialTitle': 'Regular and Unplanned Care Adaptive Dashboard for Cross-border Emergencies (RAPIDE): The Feasibility of a Hybrid Care Model', 'orgStudyIdInfo': {'id': '2024-17762'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hybrid care', 'interventionNames': ['Other: Hybrid care']}], 'interventions': [{'name': 'Hybrid care', 'type': 'OTHER', 'description': 'The hybrid care model will consist of a combination of digital tools and/or task shifting of certain healthcare providers. Examples are:\n\n* Telemonitoring: patients perform self-measurements through e.g. sensors, wearables, or (mobile) applications to get insight in their health status (supporting self-management) and report this to their healthcare provider(s), when relevant\n* Teleconsultation: patients communicate with their healthcare provider(s) remotely\n* Personal health portals and self-management applications\n* Online prescription requests: patients request prescription online', 'armGroupLabels': ['Hybrid care']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Verona', 'country': 'Italy', 'contacts': [{'name': 'Mereu', 'role': 'CONTACT', 'email': 'alessandro.mereu@gmail.com'}], 'facility': 'Accademia Italiana Cure Primarie', 'geoPoint': {'lat': 45.43854, 'lon': 10.9938}}, {'city': 'Valletta', 'country': 'Malta', 'contacts': [{'name': 'Mamo', 'role': 'CONTACT', 'email': 'julian@julianmamo.com', 'phone': '+35623402340'}], 'facility': 'University of Malta', 'geoPoint': {'lat': 35.89968, 'lon': 14.5148}}, {'city': 'Nijmegen', 'country': 'Netherlands', 'contacts': [{'name': 'Hamdiui', 'role': 'CONTACT', 'email': 'nora.hamdiui@radboudumc.nl', 'phone': '+31683591809'}, {'name': 'Huis', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Radboud University Medical Center', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'city': 'Ljubljana', 'country': 'Slovenia', 'contacts': [{'name': 'Klemenc Ketiš', 'role': 'CONTACT', 'email': 'zalika.klemenc-ketis@zd-lj.si', 'phone': '+38613003941'}], 'facility': 'Community Health Centre Ljubljana', 'geoPoint': {'lat': 46.05108, 'lon': 14.50513}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Radboud University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}