Web basEd soCial Media tecHnology to Improvement in Adherence to Dual anTiplatelet Therapy Following Drug-Eluting Stent Implantation (WeChat)

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

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.

Study Overview

• Status: Unknown
• Conditions: Coronary Disease
• Intervention / Treatment: Behavioral: Usual Text Messages; Behavioral: Personalized Reminders; Behavioral: Interactive Responses

Detailed Description

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..

• Study Type: Interventional
• Enrollment (Anticipated): 760
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yong Liu, MD; Phone Number: 86-15920172292; Email: liuyong2099@126.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Recruiting
      • Guangdong General Hospital
      • Contact: Yong Liu, MD; Phone Number: 10528 86-020-83827812; Email: liuyong2099@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• aged ≥18 years
• diagnosed CHD and underwent DES implantation
• provide written informed consent

Exclusion Criteria:

• pregnancy
• malignant tumor or end-stage disease with a life expectancy of <1 year;
• refusal to use social media
• refusal to provide written informed consent for this study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; The intervention group will receive usual text messages, personalized reminders and interactive responses.	Behavioral: Usual Text Messages; 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.; Behavioral: Personalized Reminders; 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.; 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.; Behavioral: Interactive Responses; 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.; The researchers will communicate with the patients every month.
Other: Control Group; The control group will receive usual text messages only.	Behavioral: Usual Text Messages; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Discontinuation of Dual Antiplatelet Drug	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	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication Adherence	Dual antiplatelet therapy (DAPT) adherence according to proportion of days covered (PDC) by prescription.	1 year
Number of Participants with Major Adverse Cardiovascular Events	All-cause mortality,target vessel revascularization, non-fatal myocardial infarction, and stroke	1 year

Collaborators and Investigators

• Sponsor: Guangdong Provincial People's Hospital
• Collaborators: Dongguan People's Hospital; Guangzhou Panyu Central Hospital; First People's Hospital, Shunde China; Maoming People's Hospital
• Investigators: Study Chair: Yong Liu, MD, Guangdong Cardiovascular Institute,Guangdong General Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2019
• Primary Completion (Anticipated): March 30, 2021
• Study Completion (Anticipated): September 30, 2021

Study Registration Dates

• First Submitted: November 4, 2018
• First Submitted That Met QC Criteria: November 4, 2018
• First Posted (Actual): November 6, 2018

Study Record Updates

• Last Update Posted (Actual): August 26, 2020
• Last Update Submitted That Met QC Criteria: August 23, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Randomized controlled trial; Dual antiplatelet therapy; Mobile health; Discontinuation rate; Drug-eluting stent implantation
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease
• Other Study ID Numbers: GDREC2018327H

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No