Ignite Creation Date:
2025-12-24 @ 2:33 PM
Ignite Modification Date:
2026-02-03 @ 4:01 AM
Study NCT ID:
NCT03392259
Status:
UNKNOWN
Last Update Posted:
2018-03-26
First Post:
2018-01-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Usefulness of Cardiovascular Disease (CVD) Management Solution
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 666}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-02-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2019-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-03-23', 'studyFirstSubmitDate': '2018-01-01', 'studyFirstSubmitQcDate': '2018-01-01', 'lastUpdatePostDateStruct': {'date': '2018-03-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of 10-year ASCVD risk (10-year ASCVD risk at 6 months - 10-year ASCVD risk at baseline)', 'timeFrame': '6 months', 'description': 'delta 10-year ASCVD risk between baseline and 6months, %'}], 'secondaryOutcomes': [{'measure': 'Systolic blood pressure', 'timeFrame': '3 & 6 months', 'description': 'automated blood pressure, mmHg'}, {'measure': 'Diastolic blood pressure', 'timeFrame': '3 & 6 months', 'description': 'automated blood pressure, mmHg'}, {'measure': 'lipid profiles (total cholesterol, LDL, HDL)', 'timeFrame': '6 months', 'description': 'lipid profiles at 6 months, mg/dL'}, {'measure': 'body mass index', 'timeFrame': '6 months', 'description': 'body mass index at 6 months, kg/m2'}, {'measure': 'smoking rate', 'timeFrame': '6 months', 'description': 'smoking rate at 6 months, %'}, {'measure': 'degree of moderate physical activity', 'timeFrame': '6 months', 'description': 'Godin Leisure-Time Exercise Questionnaire, total score (0-7)'}, {'measure': 'depression scale questionnaire', 'timeFrame': '6 months', 'description': 'Patient Health Questionanaire-9, total score 27 (0-27)'}, {'measure': 'drug compliance', 'timeFrame': '6 months', 'description': 'Medication Adherence Rating Scale (MARS), total score 10 (0-10)'}, {'measure': 'App service satisfaction survey', 'timeFrame': '6 months', 'description': 'Patient Activation Measure-13, total score 39 (0-39)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiovascular Diseases']}, 'referencesModule': {'references': [{'pmid': '34862449', 'type': 'DERIVED', 'citation': 'Kang SH, Baek H, Cho J, Kim S, Hwang H, Lee W, Park JJ, Yoon YE, Yoon CH, Cho YS, Youn TJ, Cho GY, Chae IH, Choi DJ, Yoo S, Suh JW. Management of cardiovascular disease using an mHealth tool: a randomized clinical trial. NPJ Digit Med. 2021 Dec 3;4(1):165. doi: 10.1038/s41746-021-00535-z.'}]}, 'descriptionModule': {'briefSummary': 'We previously developed the smartphone app (Heart4U) which is coupled with electronic medical record system in Seoul National University Bundang Hospital. In this study, we aim to evaluate clinical usefulness of smartphone app regarding the control of conventional risk factors in patients with history of cardiovascular disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with atherosclerotic cardiovascular diseae\n\n 1. history of cardiovascular disease (acute myocardial infarction, unstable angina, stable angina)\n 2. history of revascularization including percutaneous coronary intervention, peripheral angioplasty or bypass surgery\n 3. history of stroke\n 4. history of peripheral arterial disease presumed to be of atherosclerotic origin\n* Patients who have smartphone and can use app by themselves\n* Patients who can speak and read Korean language\n\nExclusion Criteria:\n\n* Patients with evidences of delirium, confusion or impaired consciousness\n* Patients who are not familiar to smartphone or app\n* Patients who are not supposed to follow the study protocol adequately.'}, 'identificationModule': {'nctId': 'NCT03392259', 'briefTitle': 'Usefulness of Cardiovascular Disease (CVD) Management Solution', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Prospective Validation of Usefulness in Cardiovascular Disease (CVD) Management With CVD Management Solution Based on Interconnection to Hospital Examination', 'orgStudyIdInfo': {'id': 'B-1712-438-307'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'conventional treatment'}, {'type': 'EXPERIMENTAL', 'label': 'App group', 'description': 'conventional treatment + use of smartphone app.', 'interventionNames': ['Behavioral: Smartphone app']}], 'interventions': [{'name': 'Smartphone app', 'type': 'BEHAVIORAL', 'description': 'Installment and use of smartphone app', 'armGroupLabels': ['App group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '463707', 'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jung-Won Suh', 'role': 'CONTACT', 'email': 'suhjw1@gmail.com', 'phone': '82-31-787-7016'}], 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}, {'zip': '463707', 'city': 'Seongnam', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Ji-Hyun Lee', 'role': 'CONTACT', 'email': '94306@snubh.org', 'phone': '82-31-787-8805'}], 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 35.54127, 'lon': 127.39683}}], 'centralContacts': [{'name': 'Si-Hyuck Kang', 'role': 'CONTACT', 'email': 'eandp303@gmail.com', 'phone': '82317877027'}], 'overallOfficials': [{'name': 'Jung-Won Suh, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Bundang Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jung-Won Suh', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}