Web basEd soCial Media tecHnology to Improvement in Adherence to Dual anTiplatelet Therapy Following Drug-Eluting Stent Implantation (WeChat)
Primary Purpose
Coronary Disease
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Usual Text Messages
Personalized Reminders
Interactive Responses
Sponsored by
About this trial
This is an interventional health services research trial for Coronary Disease focused on measuring Dual antiplatelet therapy, Mobile health, Discontinuation rate, Drug-eluting stent implantation, Randomized controlled trial
Eligibility Criteria
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
Sites / Locations
- Guangdong General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Intervention Group
Control Group
Arm Description
The intervention group will receive usual text messages, personalized reminders and interactive responses.
The control group will receive usual text messages only.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Medication Adherence
Dual antiplatelet therapy (DAPT) adherence according to proportion of days covered (PDC) by prescription.
Number of Participants with Major Adverse Cardiovascular Events
All-cause mortality,target vessel revascularization, non-fatal myocardial infarction, and stroke
Full Information
NCT ID
NCT03732066
First Posted
November 4, 2018
Last Updated
August 23, 2020
Sponsor
Guangdong Provincial People's Hospital
Collaborators
Dongguan People's Hospital, First People's Hospital, Shunde China, Guangzhou Panyu Central Hospital, Maoming People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03732066
Brief Title
Web basEd soCial Media tecHnology to Improvement in Adherence to Dual anTiplatelet Therapy Following Drug-Eluting Stent Implantation
Acronym
WeChat
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 14, 2019 (Actual)
Primary Completion Date
March 30, 2021 (Anticipated)
Study Completion Date
September 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangdong Provincial People's Hospital
Collaborators
Dongguan People's Hospital, First People's Hospital, Shunde China, Guangzhou Panyu Central Hospital, Maoming People's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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..
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Disease
Keywords
Dual antiplatelet therapy, Mobile health, Discontinuation rate, Drug-eluting stent implantation, Randomized controlled trial
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomization will be performed using a centralized, computerized randomization program in a uniform 1:1 allocation ratio.
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
760 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
The intervention group will receive usual text messages, personalized reminders and interactive responses.
Arm Title
Control Group
Arm Type
Other
Arm Description
The control group will receive usual text messages only.
Intervention Type
Behavioral
Intervention Name(s)
Usual Text Messages
Intervention 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.
Intervention Type
Behavioral
Intervention Name(s)
Personalized Reminders
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Interactive Responses
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rate of Discontinuation of Dual Antiplatelet Drug
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
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Medication Adherence
Description
Dual antiplatelet therapy (DAPT) adherence according to proportion of days covered (PDC) by prescription.
Time Frame
1 year
Title
Number of Participants with Major Adverse Cardiovascular Events
Description
All-cause mortality,target vessel revascularization, non-fatal myocardial infarction, and stroke
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yong Liu, MD
Phone
86-15920172292
Email
liuyong2099@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yong Liu, MD
Organizational Affiliation
Guangdong Cardiovascular Institute,Guangdong General Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Guangdong General Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yong Liu, MD
Phone
86-020-83827812
Ext
10528
Email
liuyong2099@126.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
31915170
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.
Results Reference
derived
Learn more about this trial
Web basEd soCial Media tecHnology to Improvement in Adherence to Dual anTiplatelet Therapy Following Drug-Eluting Stent Implantation
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