NCT03732066

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
760

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 4, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 6, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

January 14, 2019

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
Last Updated

August 26, 2020

Status Verified

August 1, 2020

Enrollment Period

2.2 years

First QC Date

November 4, 2018

Last Update Submit

August 23, 2020

Conditions

Keywords

Dual antiplatelet therapyMobile healthDiscontinuation rateDrug-eluting stent implantationRandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Medication Adherence

    1 year

  • Number of Participants with Major Adverse Cardiovascular Events

    1 year

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Behavioral: Usual Text MessagesBehavioral: Personalized RemindersBehavioral: Interactive Responses

Control Group

OTHER

The control group will receive usual text messages only.

Behavioral: Usual Text Messages

Interventions

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.

Control GroupIntervention Group

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 Group

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 Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangdong General Hospital

Guangzhou, Guangdong, 510080, China

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Yong Liu, MD

    Guangdong Cardiovascular Institute,Guangdong General Hospital

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Randomization will be performed using a centralized, computerized randomization program in a uniform 1:1 allocation ratio.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

November 4, 2018

First Posted

November 6, 2018

Study Start

January 14, 2019

Primary Completion

March 30, 2021

Study Completion

September 30, 2021

Last Updated

August 26, 2020

Record last verified: 2020-08

Locations