Coronary DiseaseWeChatNCT03732066
Web basEd soCial Media tecHnology to Improvement in Adherence to Dual anTiplatelet Therapy Following Drug-Eluting Stent Implantation
A study testing Usual Text Messages, Personalized Reminders and Interactive Responses in people with Coronary Disease, run by Guangdong Provincial People's Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Disease
- What is being tested?
- Usual Text Messages, Personalized Reminders and Interactive Responses
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 760 participants
- Where
- 1 siteChina
- Study dates
- 14 Jan 2019to 30 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged ≥18 years
- diagnosed CHD and underwent DES implantation
- provide written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangdong General Hospital
Guangzhou, Guangdong, 510080
Yong Liu, MD, 86-020-83827812 ext. 10528, liuyong2099@126.com
About this study
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
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.
Read the 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
- Being tested
- Usual Text Messages, Personalized Reminders, Interactive Responses
- Keywords
- Dual antiplatelet therapy, Mobile health, Discontinuation rate, Drug-eluting stent implantation, Randomized controlled trial
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual Text MessagesBehavioural
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 RemindersBehavioural
- 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 ResponsesBehavioural
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | The intervention group will receive usual text messages, personalized reminders and interactive responses. Receives: Behavioral: Usual Text Messages; Behavioral: Personalized Reminders; Behavioral: Interactive Responses |
| Control Group | Other | The control group will receive usual text messages only. Receives: Behavioral: Usual Text Messages |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (2)
Medication Adherence
Dual antiplatelet therapy (DAPT) adherence according to proportion of days covered (PDC) by prescription.
Measured: 1 year
Number of Participants with Major Adverse Cardiovascular Events
All-cause mortality,target vessel revascularization, non-fatal myocardial infarction, and stroke
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2018
- Study start14 Jan 2019
- Primary completion30 Mar 2021 (estimated)
- Study completion30 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary DiseaseStudies of the same condition, open and under way.
- More trials run by Guangdong Provincial People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization will be performed using a centralized, computerized randomization program in a uniform 1:1 allocation ratio.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 760 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Dongguan People's Hospital, First People's Hospital, Shunde China, Guangzhou Panyu Central Hospital, Maoming People's Hospital
- Responsible party
- Principal investigator, Liu yong, Guangdong Provincial People's Hospital
- Investigators
- Yong Liu, MD, Study chair, Guangdong Cardiovascular Institute,Guangdong General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03732066
- Sponsor's protocol ID
- GDREC2018327H
- Acronym
- Status last verified
- Aug 2020
- First submitted
- 4 Nov 2018
- Last updated
- 26 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 31915170
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03732066
- Acronym / sponsor ID
- WeChat / GDREC2018327H
- Conditions
- Coronary Disease
- Keywords
- Dual antiplatelet therapy, Mobile health, Discontinuation rate, Drug-eluting stent implantation, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 760 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Collaborators
- Dongguan People's Hospital, First People's Hospital, Shunde China, Guangzhou Panyu Central Hospital, Maoming People's Hospital
- Study start
- 14 Jan 2019 (actual)
- Primary completion
- 30 Mar 2021 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 6 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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..
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomization will be performed using a centralized, computerized randomization program in a uniform 1:1 allocation ratio.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Usual Text Messages, Behavioral: Personalized Reminders, Behavioral: Interactive ResponsesThe intervention group will receive usual text messages, personalized reminders and interactive responses. |
| Control Group | Other | Behavioral: Usual Text MessagesThe control group will receive usual text messages only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- aged ≥18 years
- diagnosed CHD and underwent DES implantation
- provide written informed consent
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual Text MessagesUsual 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. | Behavioural | Control Group, Intervention Group |
| Personalized Reminders1. 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. | Behavioural | Intervention Group |
| Interactive Responses1. 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. | Behavioural | Intervention Group |
Primary outcome
Rate of Discontinuation of Dual Antiplatelet Drug
Time frame: 1 year
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
2 secondary outcomes
Medication Adherence
Time frame: 1 year
Number of Participants with Major Adverse Cardiovascular Events
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2020.
- Derived from this study: PubMed 31915170Sun 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yong Liu, MD study chair
Guangdong Cardiovascular Institute,Guangdong General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Usual Text Messages, Personalized Reminders and Interactive Responses in people with Coronary Disease, run by Guangdong Provincial People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yong Liu, MD (86-15920172292, liuyong2099@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Discontinuation of Dual Antiplatelet Drug (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03732066, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2020.