Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:11 AM
Study NCT ID:
NCT04795505
Status:
COMPLETED
Last Update Posted:
2023-02-16
First Post:
2021-03-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Tertiary A-level Hospital Remote Intervention on MACCE, Adherence to Drugs and Risk Factors Control in Patients With Stable Coronary Artery Disease Compared With Traditional Community Hospital Follow-up
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060050', 'term': 'Angina, Stable'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D054058', 'term': 'Acute Coronary Syndrome'}], 'ancestors': [{'id': 'D000787', 'term': 'Angina Pectoris'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008722', 'term': 'Methods'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1424}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-15', 'studyFirstSubmitDate': '2021-03-09', 'studyFirstSubmitQcDate': '2021-03-11', 'lastUpdatePostDateStruct': {'date': '2023-02-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MACCE', 'timeFrame': '1 year', 'description': 'acute myocardial infarction, acute heart failure, stroke, rehospitalization for cardiovascular event, death from a cardiovascular cause and unplanned revascularization'}], 'secondaryOutcomes': [{'measure': 'blood pressure', 'timeFrame': '1 year', 'description': 'BP was measured twice by an electronic device after 10 min of seated rest and calculated as the mean of 2 measurements.'}, {'measure': 'heart rates', 'timeFrame': '1 year', 'description': 'standard protocol'}, {'measure': 'smoking cessation', 'timeFrame': '1 year', 'description': 'self-reported'}, {'measure': 'drinking cessation', 'timeFrame': '1 year', 'description': 'self-reported'}, {'measure': 'body mass index', 'timeFrame': '1 year', 'description': 'standard protocol'}, {'measure': 'medications adherence', 'timeFrame': '1 year', 'description': 'self-reported'}, {'measure': 'LDL', 'timeFrame': '1 year', 'description': 'standard protocol'}, {'measure': 'HbA1c', 'timeFrame': '1 year', 'description': 'standard protocol'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stable Chronic Angina', 'Ischemic Heart Disease', 'Acute Coronary Syndrome']}, 'referencesModule': {'references': [{'pmid': '30998400', 'type': 'BACKGROUND', 'citation': 'Zheng X, Spatz ES, Bai X, Huo X, Ding Q, Horak P, Wu X, Guan W, Chow CK, Yan X, Sun Y, Wang X, Zhang H, Liu J, Li J, Li X, Spertus JA, Masoudi FA, Krumholz HM. Effect of Text Messaging on Risk Factor Management in Patients With Coronary Heart Disease: The CHAT Randomized Clinical Trial. Circ Cardiovasc Qual Outcomes. 2019 Apr;12(4):e005616. doi: 10.1161/CIRCOUTCOMES.119.005616.'}, {'pmid': '32745732', 'type': 'BACKGROUND', 'citation': 'Yu C, Liu C, Du J, Liu H, Zhang H, Zhao Y, Yang L, Li X, Li J, Wang J, Wang H, Liu Z, Rao C, Zheng Z; MISSION-2 Collaborative Group. Smartphone-based application to improve medication adherence in patients after surgical coronary revascularization. Am Heart J. 2020 Oct;228:17-26. doi: 10.1016/j.ahj.2020.06.019. Epub 2020 Jul 4.'}, {'pmid': '32858284', 'type': 'BACKGROUND', 'citation': 'Chen X, Zhou X, Li H, Li J, Jiang H. The value of WeChat application in chronic diseases management in China. Comput Methods Programs Biomed. 2020 Nov;196:105710. doi: 10.1016/j.cmpb.2020.105710. Epub 2020 Aug 14.'}, {'pmid': '34569467', 'type': 'DERIVED', 'citation': 'Shi B, Liu X, Dong Q, Yang Y, Cai Z, Wang H, Yin D, Wang H, Dou K, Song W. The Effect of a WeChat-Based Tertiary A-Level Hospital Intervention on Medication Adherence and Risk Factor Control in Patients With Stable Coronary Artery Disease: Multicenter Prospective Study. JMIR Mhealth Uhealth. 2021 Oct 27;9(10):e32548. doi: 10.2196/32548.'}], 'seeAlsoLinks': [{'url': 'https://www.statista.com/statistics/255778/number-of-active-wechat-messenger-accounts/#statisticContainer', 'label': 'Number of monthly active WeChat users from 2nd quarter 2011 to 2nd quarter 2020(in millions)'}]}, 'descriptionModule': {'briefSummary': 'The study was a multicenter, two-arm, parallel, open label, prospective study intended for to compare effect of offline community hospital intervention on adherence to drugs and risk factors control in patients with stable coronary artery disease compared with tertiary A-level hospital WeChat-based intervention.', 'detailedDescription': "Objective: This study is intended for to compare effect of offline community hospital intervention on adherence to drugs and risk factors control in patients with stable coronary artery disease compared with tertiary A-level hospital WeChat-based intervention.\n\nStudy design: The study was a multicenter, two-arm, parallel, open label, prospective study that evaluated a WeChat-based intervention offered by tertiary A-level hospital with 1 year of follow-up.\n\nStudy intervention: All patients received lifestyle intervention and drug adjustment at 1 month, 3 months, 6 months and 1 year follow-up. In the control group, the subsequent visit was through an offline outpatient clinic at 4 different community hospitals. Participants in this group received standard outpatient cardiology follow-up with formal cardiac rehabilitation and secondary prevention. While in the intervention group, the subsequent visit was through WeChat-based online consultations.\n\nOutcome measures: The primary outcome was MACCE. Secondary outcome included blood pressure, heart rates, smoking cessation, drinking cessation, body mass index, and medications adherence.\n\nStatistical analysis: Values of analyzed endpoints between intervention group and control group will be compared according to the analysis plan. We'll follow a prespecified analysis plan and subgroup analysis will be conducted accordingly."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants are screened from several community hospitals and tertiary-A hospitals in Beijing', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. aged between 18-99 years\n2. diagnosed with SCAD according to guidelines by coronary CTA or coronary angiography (including stable angina, ischemic cardiomyopathy, and the stable course after acute coronary syndrome)\n3. have sufficient Chinese language proficiency to reading, speaking and listening\n4. live with at least one caregiver or guardian in the household\n5. presence of stable hemodynamics without using vasopressor\n6. able to individually consent\n7. not participating in any other clinical trial\n\nExclusion Criteria:\n\n1. unable to provide informed consent\n2. unable to be involved in clinical follow up and treatment\n3. suffered comorbidity with a life expectancy of less than 1 year\n4. have contra-indication to cardiac rehabilitation\n5. acute coronary syndrome'}, 'identificationModule': {'nctId': 'NCT04795505', 'acronym': 'CHIPCHAT', 'briefTitle': 'Effect of Tertiary A-level Hospital Remote Intervention on MACCE, Adherence to Drugs and Risk Factors Control in Patients With Stable Coronary Artery Disease Compared With Traditional Community Hospital Follow-up', 'organization': {'class': 'OTHER', 'fullName': 'Chinese Academy of Medical Sciences, Fuwai Hospital'}, 'officialTitle': 'Effect of Tertiary A-level Hospital Remote Intervention on MACCE, Adherence to Drugs and Risk Factors Control in Patients With Stable Coronary Artery Disease Compared With Traditional Community Hospital Follow-up', 'orgStudyIdInfo': {'id': 'CHIPCHAT'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Intervention group', 'description': 'A tertiary A-level hospital WeChat-based intervention', 'interventionNames': ['Behavioral: Intervention']}, {'label': 'Control group', 'description': 'Traditional community hospital intervention', 'interventionNames': ['Behavioral: Control']}], 'interventions': [{'name': 'Intervention', 'type': 'BEHAVIORAL', 'description': 'The subsequent visit was through WeChat-based online consultations. Follow-up, assessments and feedback were done at each visit. After follow-up, medication adherence and risk factor modification status were assessed, then individualized feedback, encouragement and recommendations were provided.', 'armGroupLabels': ['Intervention group']}, {'name': 'Control', 'type': 'BEHAVIORAL', 'description': 'The subsequent visit was through an offline outpatient clinic at 4 different community hospitals. Participants in this group received standard outpatient cardiology follow-up with formal cardiac rehabilitation and secondary prevention', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100000', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Fuwai Hospital, Chinese Academy of Medical Science; National Center for Cardiovascular Diseases', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Weihua Song, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fuwai Hospital, Chinese Academy of Medical Science; National Center for Cardiovascular Diseases'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese Academy of Medical Sciences, Fuwai Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Weihua Song', 'investigatorAffiliation': 'Chinese Academy of Medical Sciences, Fuwai Hospital'}}}}