Ignite Creation Date:
2025-12-26 @ 4:04 PM
Ignite Modification Date:
2025-12-26 @ 4:04 PM
Study NCT ID:
NCT06844006
Status:
RECRUITING
Last Update Posted:
2025-03-07
First Post:
2025-02-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Investigating the Impact of Nudging Cardiologists to Prescribe Guideline-directed Medical Therapy in Heart Failure Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Stepped Wedge Randomized Controlled Trial.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1320}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2028-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-06', 'studyFirstSubmitDate': '2025-02-19', 'studyFirstSubmitQcDate': '2025-02-19', 'lastUpdatePostDateStruct': {'date': '2025-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HF related hospitalization', 'timeFrame': 'From enrollment to the end of the design (15 months).', 'description': 'The frequency of HF related hospitalization and duration of the hospitalization.'}, {'measure': 'All cause death', 'timeFrame': 'All cause death rate during the 15 month duration of the study.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Digitial Care', 'Home monitoring', 'Heart Failure', 'Nudging'], 'conditions': ['Heart Failure']}, 'referencesModule': {'references': [{'pmid': '39217271', 'type': 'BACKGROUND', 'citation': 'Man JP, Koole MAC, Meregalli PG, Handoko ML, Stienen S, de Lange FJ, Winter MM, Schijven MP, Kok WEM, Kuipers DI, van der Harst P, Asselbergs FW, Zwinderman AH, Dijkgraaf MGW, Chamuleau SAJ, Schuuring MJ. Digital consults in heart failure care: a randomized controlled trial. Nat Med. 2024 Oct;30(10):2907-2913. doi: 10.1038/s41591-024-03238-6. Epub 2024 Aug 31.'}], 'seeAlsoLinks': [{'url': 'https://www.nature.com/articles/s41591-024-03238-6', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This study investigates the impact of a nudge-based intervention on improving guideline directed medical therapy (GDMT) prescription among cardiologists. Using a stepped wedge randomized controlled trial design, we assess whether digital decision support-leveraging home monitoring and clinical data-enhances adherence to guideline-recommended medication titration. The primary outcomes include HF related hospitalization rates and all cause mortality.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All heart failure diagnoses\n* \\>18 years\n\nExclusion Criteria:\n\n* Not understanding the Dutch Language.\n* Allergies that make uptitration impossible.\n* Admission to hospice or palliative care.\n* Severe psychological disorders.'}, 'identificationModule': {'nctId': 'NCT06844006', 'acronym': 'ADMINISTER II', 'briefTitle': 'Investigating the Impact of Nudging Cardiologists to Prescribe Guideline-directed Medical Therapy in Heart Failure Patients', 'organization': {'class': 'OTHER', 'fullName': 'Medisch Spectrum Twente'}, 'officialTitle': 'Assessment of Digital Care on Clinical Impact and Efficiency Using a Stepped Wedge Cluster RCT in Heart Failure Patients: the ADMINISTER II Trial', 'orgStudyIdInfo': {'id': 'ADMINISTER II'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Intervention', 'description': 'All cardiologists will be nudged during the trial. with the use of a stepped wedge design there will be a structured embedding in the current standard of care.', 'interventionNames': ['Combination Product: Nudging']}], 'interventions': [{'name': 'Nudging', 'type': 'COMBINATION_PRODUCT', 'description': 'Clinicians will be nudged with a prompt, based on remote monitoring data, current medication data, contraindications, in the electronic patient dossier whether further optimization to guideline directed medical therapy (GDMT) is possible.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7512KZ', 'city': 'Enschede', 'state': 'Overijssel', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'M.D., Ph.D., FESC, FEACVI, FHFA', 'role': 'CONTACT', 'email': 'mark.schuuring@mst.nl'}], 'facility': 'Medisch Spectrum Twente', 'geoPoint': {'lat': 52.21833, 'lon': 6.89583}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medisch Spectrum Twente', 'class': 'OTHER'}, 'collaborators': [{'name': 'Onze Lieve Vrouwe Gasthuis', 'class': 'OTHER'}, {'name': 'St. Antonius Hospital', 'class': 'OTHER'}, {'name': 'Martini Hospital Groningen', 'class': 'OTHER'}, {'name': 'Catharina Ziekenhuis Eindhoven', 'class': 'OTHER'}, {'name': 'Canisius Wilhelmina Ziekenhuis (CWZ)', 'class': 'UNKNOWN'}, {'name': 'Maasstad Hospital, Rotterdam', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistent Professor M.J. Schuuring (M.D., Ph. D., FESC, FEACVI, FHFA)', 'investigatorFullName': 'Mark Schuuring', 'investigatorAffiliation': 'Medisch Spectrum Twente'}}}}