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

NCT ID: NCT03732066

Last Updated: 2020-08-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 760 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-14
• Study Completion Date: 2021-09-30

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..

Conditions

Coronary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: TRIPLE

Study Groups

Intervention Group

The intervention group will receive usual text messages, personalized reminders and interactive responses.

Group Type: EXPERIMENTAL

Usual Text Messages

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

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.

2. 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

Intervention Type: BEHAVIORAL

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.

2. The researchers will communicate with the patients every month.

Control Group

The control group will receive usual text messages only.

Group Type: OTHER

Usual Text Messages

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Personalized Reminders

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.

2. 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

Interactive Responses

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.

2. The researchers will communicate with the patients every month.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dongguan People's Hospital

OTHER_GOV

Sponsor Role: collaborator

First People's Hospital, Shunde China

OTHER

Sponsor Role: collaborator

Guangzhou Panyu Central Hospital

OTHER

Sponsor Role: collaborator

Maoming People's Hospital

OTHER

Sponsor Role: collaborator

Guangdong Provincial People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Liu yong

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yong Liu, MD

Role: STUDY_CHAIR

Guangdong Cardiovascular Institute,Guangdong General Hospital

Locations

Guangdong General Hospital

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yong Liu, MD

Role: CONTACT

liuyong2099@126.com

86-15920172292

Facility Contacts

Yong Liu, MD

Role: primary

liuyong2099@126.com

86-020-83827812 ext. 10528

References

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.

Reference Type: DERIVED

PMID: 31915170 (View on PubMed)

Other Identifiers

GDREC2018327H

Identifier Type: -

Identifier Source: org_study_id