Ignite Creation Date:
2025-12-24 @ 4:04 PM
Ignite Modification Date:
2026-01-05 @ 5:51 PM
Study NCT ID:
NCT03732066
Status:
UNKNOWN
Last Update Posted:
2020-08-26
First Post:
2018-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Web basEd soCial Media tecHnology to Improvement in Adherence to Dual anTiplatelet Therapy Following Drug-Eluting Stent Implantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003327', 'term': 'Coronary Disease'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The patients (but not their care providers), research personnel, and investigators will be unaware of their allocation. Study coordinators and research assistants conducting the assessments and statisticians will also be blinded.'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomization will be performed using a centralized, computerized randomization program in a uniform 1:1 allocation ratio.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 760}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-01-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2021-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-08-23', 'studyFirstSubmitDate': '2018-11-04', 'studyFirstSubmitQcDate': '2018-11-04', 'lastUpdatePostDateStruct': {'date': '2020-08-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of Discontinuation of Dual Antiplatelet Drug', 'timeFrame': '1 year', 'description': "Defined as discontinuation of any dual antiplatelet drug owing to patients' own discretion, including bleeding or non-compliance rather than doctors' advice. Changing of DAPT medication between ticagrelor and clopidogrel under doctors' advice will not be identified as dual antiplatelet drug discontinuation; changing of such under own discretion will be identified as such"}], 'secondaryOutcomes': [{'measure': 'Medication Adherence', 'timeFrame': '1 year', 'description': 'Dual antiplatelet therapy (DAPT) adherence according to proportion of days covered (PDC) by prescription.'}, {'measure': 'Number of Participants with Major Adverse Cardiovascular Events', 'timeFrame': '1 year', 'description': 'All-cause mortality,target vessel revascularization, non-fatal myocardial infarction, and stroke'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dual antiplatelet therapy', 'Mobile health', 'Discontinuation rate', 'Drug-eluting stent implantation', 'Randomized controlled trial'], 'conditions': ['Coronary Disease']}, 'referencesModule': {'references': [{'pmid': '31915170', 'type': 'DERIVED', 'citation': 'Sun GL, Lei L, Liu L, Liu J, He Y, Guo Z, Dai X, He L, Chen SQ, Liang Y, Ye J, Hu Y, Chen G, Chen JY, Liu Y. Rationale and design of the Web-basEd soCial media tecHnology to improvement in Adherence to dual anTiplatelet Therapy following Drug-Eluting Stent Implantation (WECHAT): protocol for a randomised controlled study. BMJ Open. 2020 Jan 7;10(1):e033017. doi: 10.1136/bmjopen-2019-033017.'}]}, 'descriptionModule': {'briefSummary': 'Few studies have attempt to improve DAPT adherence through social media. The investigators will explore the prevalence of DAPT discontinuation and prove the hypothesis that using social media will improve DAPT adherence among patients requiring DAPT following DES implantation.', 'detailedDescription': 'Dual antiplatelet therapy (DAPT) is frequently discontinued after drug-eluting stent (DES) implantation, which could lead to many major adverse cardiovascular events (MACEs). Social media have been proven effective in improving lifestyles and blood pressures control, but few studies have attempt to improve DAPT adherence through social media.Therefore, eligible patients will be enrolled through scanning QR code and randomized in a 1:1 ratio to an intervention group or control group with 12 months of follow-up.The investigators will find out the prevalence of DAPT discontinuation and prove the hypothesis that using social media will improve DAPT adherence among patients requiring DAPT following DES implantation..'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged ≥18 years\n* diagnosed CHD and underwent DES implantation\n* provide written informed consent\n\nExclusion Criteria:\n\n* pregnancy\n* malignant tumor or end-stage disease with a life expectancy of \\<1 year;\n* refusal to use social media\n* refusal to provide written informed consent for this study'}, 'identificationModule': {'nctId': 'NCT03732066', 'acronym': 'WeChat', 'briefTitle': 'Web basEd soCial Media tecHnology to Improvement in Adherence to Dual anTiplatelet Therapy Following Drug-Eluting Stent Implantation', 'organization': {'class': 'OTHER', 'fullName': "Guangdong Provincial People's Hospital"}, 'officialTitle': 'Web basEd soCial Media tecHnology to Improvement in Adherence to Dual anTiplatelet Therapy Following Drug-Eluting Stent Implantation (WeChat), a Randomized Controlled Branch on Antiplatelet of RESCIND Study', 'orgStudyIdInfo': {'id': 'GDREC2018327H'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Group', 'description': 'The intervention group will receive usual text messages, personalized reminders and interactive responses.', 'interventionNames': ['Behavioral: Usual Text Messages', 'Behavioral: Personalized Reminders', 'Behavioral: Interactive Responses']}, {'type': 'OTHER', 'label': 'Control Group', 'description': 'The control group will receive usual text messages only.', 'interventionNames': ['Behavioral: Usual Text Messages']}], 'interventions': [{'name': 'Usual Text Messages', 'type': 'BEHAVIORAL', 'description': 'Usual text messages four times a week, including cardiovascular knowledge and follow-up reminders, such as risk factors for CHD and typical symptoms of myocardial infarction.', 'armGroupLabels': ['Control Group', 'Intervention Group']}, {'name': 'Personalized Reminders', 'type': 'BEHAVIORAL', 'description': "1. The mHealth tools will provide special interventions according to the patients' medical history. For example, patients with hypertension will receive daily reminders on blood pressure measurement and medication. They will also receive early warning on hypertension with a systolic blood pressure of \\>180 mmHg or \\<90 mmHg. Patients who smoke will be required to quit smoking. Every patient will receive a Health Report monthly, which will reflect their drug compliance, blood pressure and so on.\n2. Drug Reminders: Patients' medication information will be recorded by obtaining pictures of their medication. Patients will be asked to punch time clocks simply in the mHealth tools. If they forget to punch cards, they can punch cards whenever they think of it. If there is no record of medication for 3 days, SMS alerts will be received, and phone calls will be received over 7 days.", 'armGroupLabels': ['Intervention Group']}, {'name': 'Interactive Responses', 'type': 'BEHAVIORAL', 'description': '1. Auto-Response: After sending personal or discomfort symptom questions, the patients will be provided with an automatic response pushed by the back-end database by crawling the keywords. It is suggested that the answer is just for reference. In case of urgent questions, they will be advised to consult the clinicians.\n2. The researchers will communicate with the patients every month.', 'armGroupLabels': ['Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510080', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yong Liu, MD', 'role': 'CONTACT', 'email': 'liuyong2099@126.com', 'phone': '86-020-83827812', 'phoneExt': '10528'}], 'facility': 'Guangdong General Hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Yong Liu, MD', 'role': 'CONTACT', 'email': 'liuyong2099@126.com', 'phone': '86-15920172292'}], 'overallOfficials': [{'name': 'Yong Liu, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Guangdong Cardiovascular Institute,Guangdong General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Guangdong Provincial People's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': "Dongguan People's Hospital", 'class': 'OTHER_GOV'}, {'name': "First People's Hospital, Shunde China", 'class': 'OTHER'}, {'name': 'Guangzhou Panyu Central Hospital', 'class': 'OTHER'}, {'name': "Maoming People's Hospital", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Liu yong', 'investigatorAffiliation': "Guangdong Provincial People's Hospital"}}}}