Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2026-03-08 @ 1:07 AM
Study NCT ID:
NCT02599857
Status:
WITHDRAWN
Last Update Posted:
2017-05-24
First Post:
2015-11-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of a CONCOR Smartphone Application
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'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': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'never started', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2017-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2017-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-05-23', 'studyFirstSubmitDate': '2015-11-05', 'studyFirstSubmitQcDate': '2015-11-06', 'lastUpdatePostDateStruct': {'date': '2017-05-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-11-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite of arrhythmia and heart failure events', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Quality of life questionnaire', 'timeFrame': '1 year'}, {'measure': 'Mortality', 'timeFrame': '1 year'}, {'measure': 'Medication adherence questionnaire', 'timeFrame': '1 year'}, {'measure': 'Usability and learnability questionnaire', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Congenital Heart Disease', 'Smartphone Application', 'Arrhythmia', 'Heart Failure', 'mHealth', 'Mobile Health']}, 'descriptionModule': {'briefSummary': 'Life expectancy of children with congenital heart disease (CHD) has increased dramatically during the past years, due to the successes of cardiac surgery. Nearly all of these children with CHD can be operated at young age and more than 90% reach adulthood. However, many adults with CHD are life-long affected by cardiac events, particularly arrhythmias and heart failure, putting them at risk of premature death. These events have a large impact on quality of life of patients and their families and merit life-long hospital visits in a medical center specialized in adult CHD. Especially for adults with CHD patient care with a smartphone is suited because of their young age and chronic condition. So far, data are lacking on smartphone interventions in patients with CHD.', 'detailedDescription': 'The investigators aim to determine feasibility of CONCOR smartphone application management in adults with CHD. Moreover, during a twelve months follow up period the investigators aim to evaluate whether management with a CONCOR smartphone application results in a lower rate of heart failure events and arrhythmia as well as a better quality of life than usual care, because of increased patient awareness, behavioral stimuli, healthy life style reminders and more precise medical treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults with CHD being an Academic Medical Center (AMC) patient and/ or patients registered in the Dutch CONCOR registry\n* Owning a smartphone\n\nExclusion Criteria:\n\n* Mental retardation and/ or Down syndrome'}, 'identificationModule': {'nctId': 'NCT02599857', 'briefTitle': 'The Effects of a CONCOR Smartphone Application', 'organization': {'class': 'OTHER', 'fullName': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}, 'officialTitle': 'The Effects of a CONCOR Smartphone Application on Arrhythmia, Heart Failure Events and Quality of Life in Patients With Congenital Heart Disease: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2015-126481'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CONCOR smartphone application', 'description': 'Use of CONCOR smartphone application', 'interventionNames': ['Device: CONCOR smartphone application']}, {'type': 'NO_INTERVENTION', 'label': 'Standard care (no CONCOR smartphone application)', 'description': 'No CONCOR smartphone application'}], 'interventions': [{'name': 'CONCOR smartphone application', 'type': 'DEVICE', 'armGroupLabels': ['CONCOR smartphone application']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Academic Medical Center', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD PhD', 'investigatorFullName': 'Mark Schuuring', 'investigatorAffiliation': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}}}}