Ignite Creation Date:
2025-12-24 @ 5:36 PM
Ignite Modification Date:
2026-02-21 @ 11:36 PM
Study NCT ID:
NCT05773768
Status:
RECRUITING
Last Update Posted:
2024-12-13
First Post:
2023-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EHRA-PATHS: Clinical and Health Economic Evaluation of New Care Pathways
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1300}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-09', 'studyFirstSubmitDate': '2023-02-15', 'studyFirstSubmitQcDate': '2023-03-15', 'lastUpdatePostDateStruct': {'date': '2024-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Identification and management of risk factors and comorbidities', 'timeFrame': '6 months', 'description': 'The number of risk factors and comorbidities that are identified and for which treatment is initiated during base mapping and at the end of the randomized controlled trial.'}], 'secondaryOutcomes': [{'measure': 'AF symptom burden', 'timeFrame': '6 months', 'description': 'Measured with the Atrial Fibrillation Severity Scale (AFSS) questionnaire'}, {'measure': 'Quality of life (QoL)', 'timeFrame': '6 months', 'description': 'Measured with the EuroQol five-dimensional five-level (EQ-5D-5L) questionnaire'}, {'measure': 'Referrals to other disciplines', 'timeFrame': '6 months', 'description': 'The referrals to other disciplines will consist of the number of referrals and the percentage of patients referred.'}, {'measure': 'Patient and health care provider satisfaction', 'timeFrame': '6 months', 'description': 'Measured with a patient and health care provider (HCP) satisfaction questionnaire'}, {'measure': 'Healthcare resource use/costs', 'timeFrame': '6 months', 'description': 'Measured with the iMedical Consumption Questionnaire (iMCQ)'}, {'measure': 'HRQoL/utility', 'timeFrame': '6 months', 'description': 'Measured with the EQ-5D-5L questionnaire (iMCQ)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'In elderly atrial fibrillation (AF) patients, AF is usually a manifestation of risk factors and comorbidities not only limited to cardiovascular diseases. Especially in elderly often more than two comorbidities are present. The presence of comorbidities also affects outcomes in AF patients. Current healthcare systems are single-disease focused, which increases the risk of underdiagnosing, replicating diagnostic tests and adverse drug-drug interactions, placing a high burden on healthcare costs. Healthcare systems and hospitals are in need of new care pathways to address the complexity of multimorbid AF patients and to reduce costs. The EHRA-PATHS consortium set out to address this need for change in management for multimorbid, elderly AF patients in Europe through the development of new care pathways. The aim of this study is to evaluate the current management of risk factors and comorbidities, and subsequently implement the newly developed care pathways and evaluate if these pathways lead to better management of risk factors and comorbidities in multimorbid, elderly AF patients, compared to current standard care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Newly diagnosed atrial fibrillation (paroxysmal, persistent or permanent)\n* ≥65 years of age\n* Willing and able to participate and to attend the scheduled follow-up visits.\n\nExclusion Criteria:\n\n* Atrial fibrillation episode was due to a trigger (i.e. postoperative, infection, hyperthyroidism etc.)\n* Life expectancy of less than 1 year\n* Participation in another clinical study (registry studies not included)\n* Severe cognitive impairment / dementia (defined based on MMSE and CDR scoring systems)'}, 'identificationModule': {'nctId': 'NCT05773768', 'acronym': 'EHRA-PATHS', 'briefTitle': 'EHRA-PATHS: Clinical and Health Economic Evaluation of New Care Pathways', 'organization': {'class': 'OTHER', 'fullName': 'University Medical Center Groningen'}, 'officialTitle': 'EHRA-PATHS: Addressing Multimorbidity in Elderly Atrial Fibrillation Patients Through Interdisciplinary, Patient-centred Systematic Care Pathways - Clinical and Health Economic Evaluation of New Care Pathways', 'orgStudyIdInfo': {'id': 'EHRA-PATHS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'New care program', 'description': "The health care provider will use the EHRA-PATHS' newly developed care pathways to assess whether there is an indication for presence of risk factors and comorbidities. If this is the case, the care pathways will show possible next steps for confirming the presence of these risk factors and comorbidities. If confirmed, treatment according to the current guidelines should be initiated. Since this leads to an individualized management plan, procedures can differ between patients and will also depend on local processes.", 'interventionNames': ['Device: EHRA-PATHS software tool']}, {'type': 'NO_INTERVENTION', 'label': 'Routine clinical care', 'description': 'The health care provider follows current clinical practice with regards to history taking, physical examination etc.'}], 'interventions': [{'name': 'EHRA-PATHS software tool', 'type': 'DEVICE', 'description': 'Newly developed care pathways integrated into a care-management software tool', 'armGroupLabels': ['New care program']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Groningen', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Bart A Mulder, MD/PhD', 'role': 'CONTACT', 'email': 'b.a.mulder@umcg.nl', 'phone': '0655257399'}], 'facility': 'University Medical Center Groningen', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medical Center Groningen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}