Ignite Creation Date:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2026-01-07 @ 8:44 AM
Study NCT ID:
NCT00753259
Status:
COMPLETED
Last Update Posted:
2010-04-20
First Post:
2008-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Atrial Fibrillation (AF) Clinic to Improve the Treatment of Patients With Atrial Fibrillation.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D006333', 'term': 'Heart Failure'}], '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'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 712}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-04', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-04-19', 'studyFirstSubmitDate': '2008-09-15', 'studyFirstSubmitQcDate': '2008-09-15', 'lastUpdatePostDateStruct': {'date': '2010-04-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite of heart failure, thromboembolic complications, bleeding, severe adverse effects of drugs and death from cardiovascular causes.', 'timeFrame': 'minimum of 1 year'}], 'secondaryOutcomes': [{'measure': 'All cause mortality, all cause hospitalizations, Treatment (benchmarking) in accordance to the 2006 AHA/ACC/ESC guidelines in AF, quality of life, patient satisfaction, anxiety, depression, compliance and cost effectiveness.', 'timeFrame': 'minimum of 1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['atrial fibrillation', 'disease management program', 'integrated chronic care program', 'guideline', 'stroke', 'heart failure', 'quality of life', 'costs'], 'conditions': ['Atrial Fibrillation']}, 'referencesModule': {'references': [{'pmid': '24058179', 'type': 'DERIVED', 'citation': 'Hendriks JM, Vrijhoef HJ, Crijns HJ, Brunner-La Rocca HP. The effect of a nurse-led integrated chronic care approach on quality of life in patients with atrial fibrillation. Europace. 2014 Apr;16(4):491-9. doi: 10.1093/europace/eut286. Epub 2013 Sep 20.'}, {'pmid': '23305860', 'type': 'DERIVED', 'citation': 'Hendriks JM, Crijns HJ, Tieleman RG, Vrijhoef HJ. The atrial fibrillation knowledge scale: development, validation and results. Int J Cardiol. 2013 Sep 30;168(2):1422-8. doi: 10.1016/j.ijcard.2012.12.047. Epub 2013 Jan 8.'}, {'pmid': '22453654', 'type': 'DERIVED', 'citation': 'Hendriks JM, de Wit R, Crijns HJ, Vrijhoef HJ, Prins MH, Pisters R, Pison LA, Blaauw Y, Tieleman RG. Nurse-led care vs. usual care for patients with atrial fibrillation: results of a randomized trial of integrated chronic care vs. routine clinical care in ambulatory patients with atrial fibrillation. Eur Heart J. 2012 Nov;33(21):2692-9. doi: 10.1093/eurheartj/ehs071. Epub 2012 Mar 27.'}, {'pmid': '20089253', 'type': 'DERIVED', 'citation': 'Hendriks JM, de Wit R, Vrijhoef HJ, Tieleman RG, Crijns HJ. An integrated chronic care program for patients with atrial fibrillation: study protocol and methodology for an ongoing prospective randomised controlled trial. Int J Nurs Stud. 2010 Oct;47(10):1310-6. doi: 10.1016/j.ijnurstu.2009.12.017. Epub 2010 Jan 20.'}]}, 'descriptionModule': {'briefSummary': "* Randomized controlled trial comparing specialized AF Clinic with 'care as usual'\n* Hypothesis: treatment of AF patients in the AF-Clinic by a nurse, specialised in AF, using guideline-based dedicated software, under supervision of a cardiologist, is efficient, safe and not inferior to care as usual by a cardiologists."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Newly diagnosed atrial fibrillation\n\nExclusion Criteria:\n\n* Age \\< 18 years\n* unwillingness to participate'}, 'identificationModule': {'nctId': 'NCT00753259', 'acronym': 'AFClinic', 'briefTitle': 'Atrial Fibrillation (AF) Clinic to Improve the Treatment of Patients With Atrial Fibrillation.', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University Medical Center'}, 'officialTitle': 'The Effect of a Nurse-driven ICT-supported Disease Management Program to Improve the Treatment of Patients With Atrial Fibrillation.', 'orgStudyIdInfo': {'id': 'MEC 06-4-043'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AF Clinic', 'interventionNames': ['Other: AF Clinic']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Care as Usual', 'interventionNames': ['Other: Care as Usual']}], 'interventions': [{'name': 'AF Clinic', 'type': 'OTHER', 'description': 'Treatment of atrial fibrillation patients by specialized nurses, supervised by cardiologists, using dedicated software to ensure maximal adherence to AHA/ACC/ESC guidelines on atrial fibrillation treatment', 'armGroupLabels': ['AF Clinic']}, {'name': 'Care as Usual', 'type': 'OTHER', 'description': 'Routine clinical care of atrial fibrillation patients, provided by cardiologists, without the help of specialized nurses or dedicated software.', 'armGroupLabels': ['Care as Usual']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9700 RM', 'city': 'Groningen', 'country': 'Netherlands', 'facility': 'Martini Hospital Groningen', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}, {'zip': '6202 AZ', 'city': 'Maastricht', 'country': 'Netherlands', 'facility': 'MaastrichtUMC', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}], 'overallOfficials': [{'name': 'Robert G Tieleman, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maastricht UMC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr RG Tieleman, MD, PhD', 'oldOrganization': 'Dept of Cardiology, Maastricht University Medical Center'}}}}