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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03732066
Other study ID # GDREC2018327H
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 14, 2019
Est. completion date September 30, 2021

Study information

Verified date August 2020
Source Guangdong Provincial People's Hospital
Contact Yong Liu, MD
Phone 86-15920172292
Email liuyong2099@126.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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..


Recruitment information / eligibility

Status Recruiting
Enrollment 760
Est. completion date September 30, 2021
Est. primary completion date March 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.
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.

Locations

Country Name City State
China Guangdong General Hospital Guangzhou Guangdong

Sponsors (5)

Lead Sponsor Collaborator
Guangdong Provincial People's Hospital Dongguan People's Hospital, First People's Hospital, Shunde China, Guangzhou Panyu Central Hospital, Maoming General Hospital

Country where clinical trial is conducted

China, 

Outcome

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