Coronary Artery DiseaseNCT04119726
The Study Design of a Mobile Health (mHealth) Technology Associated Improvement of Drug Adherence in Patients With Acute Myocardial Infarction and Protocol for the Randomized, Controlled Trial（RESCIND-3)
A study testing Usual Text Messages, Personalized reminders and Internet-based counselling in people with Coronary Artery Disease, run by Guangdong Provincial People's Hospital at 1 site in China.
Trial summary
The RESCIND-3 study is a multicenter, double-blind, randomized controlled trial. It will be conducted in the departments of cardiology in 5 hospitals. Guangdong General Hospital ethics review board approved the study's design. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Usual Text Messages, Personalized reminders and Internet-based counselling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to Jul 2020
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥18 years
- Diagnosed with acute myocardial infarction
- Taking four kinds of cardioprotective medications(antiplatelet, ACEI/ARB, beta-blockers, and statins)
- Wechat and smartphone users
- Provide written informed consent
Who cannot join
- Pregnancy
- Malignant tumor or end-stage disease with a life expectancy of <1 year
- Unable to use mobile phone network applet
- Refuse to sign the informed consent
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
The RESCIND-3 study is a multicenter, double-blind, randomized controlled trial. It will be conducted in the departments of cardiology in 5 hospitals. Guangdong General Hospital ethics review board approved the study's design. 400 patients with AMI on admission will be continuously enrolled and randomly allocated to either the control or intervention group. The intervention group will receive internet-based counseling, individual drug reminders, recommendations for healthy lifestyles, cardiovascular education about AMI, and follow-up reminders four times a week, while the control group will only receive cardiology knowledge and follow-up reminders four times a week. Mobile health tools (WeChat applet) were developed through cooperation with a technology company to establish appropriate It will be blinding for investigators but all participants will be aware of whether their intervention is the 'experimental' treatment. Trained research nurses will conduct the follow up in the 4th, 8th, 12th months by telephone or face-to-face visit. All the adverse events will be collected through a self-reported section in the mobile health tools. The study will evaluate the acceptability, utility of the intervention based on Internet consulting management.
Read the detailed description
Background：Antithrombotic drugs, β-blockers, statins and angiotensin converting enzyme inhibitor (ACEI)/angiotensin II receptor blockers (ARB) are recommended for patients with acute myocardial infarction(AMI). However, discontinuation of the drugs was associated with higher mortality. Few studies focused on the improvement of drug compliance through mHealth tools.
Objective：To investigate whether internet-based counseling could improve drug(Antithrombotic drugs, β-blockers, statins an ACEI/ARB) compliance following percutaneous coronary intervention(PCI) among patients with AMI within 1year's follow-up.
Study design：The study is a multicenter, randomized, prospective, double-blinded study. A total of 400 AMI patients following PCI will be randomized to intervention group or control group in addition to usual post-MI care. The intervention group will receive internet-based counseling, personalized reminders(drug information, healthy lifestyles advise) and educational message (cardiovascular knowledge and follow-up reminders) four times a week. It will be only usual messages (cardiovascular knowledge and follow-up reminders) supported four times a week in the control group. The primary endpoint is the discontinuation rate of coronary heart disease secondary prevention drugs (antiplatelet, ACEI/ARB, beta-blockers, and statins). The second endpoints include drug adherence scores assessed by the proportion of days covered(PDC) and major adverse cardiovascular events. Both groups will be followed up within 1year after PCI.
Summary：The multicentre randomized trial(RESCIND-3) will provide new evidence of the effectiveness of mHealth tools on improving 12-month drug compliance following PCI among patients with AMI.
- Conditions
- Coronary Artery Disease
- Being tested
- Usual Text Messages, Personalized reminders, Internet-based counselling
- Keywords
- Mobile health, Acute myocardial infarction, Cardioprotective medications, Randomized Controlled Trial
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual Text MessagesBehavioural
Regular messages about prevention and cure of CHD will be sent to both groups four times a week. The short texts will be selected from the guidelines in China to avoid misinformation. There are also some pictures or videos that help patients change their behaviour.
Personalized remindersBehavioural
Personal information, life behavior and risk factors will be registered when patients are enrolled. According to the baseline information, personalized knowledge will be sent to patients in the intervention group. Besides, patients will receive drug information and regular medication adherence reminders daily according to patients' baseline prescription drugs and modifications.
Internet-based counsellingBehavioural
The internet-based counselling is the key module of social media in the intervention group. The consultation content mainly includes the feedback of coronary heart disease secondary prevention drug compliance, the feedback of risk factor level control, the feedback of life and behaviour habits, the feedback of adverse events, the feedback of health education knowledge improvement, the reminders of data upload, behaviour change, and health education learning.
When the patient has questions or discomfort during the medication, they can consult the applet and the applet will perform internet-based answers on the large database built by cardiologists. Meanwhile, social media will upload the question of consultation and report to the doctor according to individual differences in disease. If the patient is not satisfied with the auto-response, the patient can further consult his doctor and the doctor's response will be collected to improve the auto-response database
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Other | The control group will receive a simplified tool including only the education message. The methodology will ensure that potential confounders by differences in nonspecific support and attention could be adjusted. Regular messages about prevention and cure of CHD will be sent to both groups four times a week. The short texts will be selected from the guidelines in China to avoid misinformation. There are also some pictures or videos that help patients change their behavior. Patients will be followed up for 4/8/12 months after admission through mHealth tools or telephone. Receives: Behavioral: Usual Text Messages |
| Intervention Group | Experimental | The intervention group will receive a complete social medial tool (web-based application ) installed on mobile phones including general education about coronary disease、personalized reminders and internet-based counseling. Patients will be followed up for 4/8/12 months after admission through mHealth tools or telephone. Receives: Behavioral: Usual Text Messages; Behavioral: Personalized reminders; Behavioral: Internet-based counselling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of discontinuation of drug
The discontinuation rate of each 4 kinds of coronary heart disease secondary prevention drug (antiplatelet drugs, ACEI/ARB, beta-blockers, and statins) without any professional permission. The continuous withdrawal time will be divided into three groups: ≤7 days, 8-30 days, more than 30 days.
Measured: 1 year
Secondary outcomes (4)
Acute myocardial infarction
Clinical evidence of acute myocardial injury(typical rise and fall of biochemical markers of myocardial necrosis to greater than twice the ULN or if markers were already elevated, further elevation of a marker to >50% of a previous value that was decreasing and >2× ULN, with ≥ 1 of the following) and myocardial ischemia, including: Myocardial ischemia; New ischemic ECG changes; Pathological Q wave appears; Imaging evidence and ischemic aetiology of new myocardium loss or abnormal local ventricular wall movement; Coronary thrombosis is determined by angiography or autopsy.
Measured: 1 year
Medication discontinuance
Stop taking any one of antiplatelet drugs, β blockers, statins and ACEI/ARB without doctor's advice within one year of the onset of AMI.
Measured: 1 year
Good drug compliance
It will be measured by the proportion of days covered (PDC) during one year following hospital discharge. Patients are classified as good compliance (PDC >80%) or no-good compliance (<80%) separately to each of the 4 preventive therapies.
Measured: 1 year
Number of Participants with Major Adverse Cardiovascular Events. Target vascular revascularization (TVR)
All-cause mortality, defined as any death recorded between the date of the interview and the end of data linkage on 31 October 2016. Rehospitalization, stroke, target vascular revascularization (TVR). TVR is defined as any revascularization procedure (PCI or CABG) involving the vessel treated during the index PCI procedure for STEMI.
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 posted8 Oct 2019
- Study start1 Jan 2019
- Primary completionJun 2020 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery 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
- 400 patients with AMI on admission will be continuously enrolled and randomly allocated to either the control or intervention group. The intervention group will receive internet-based counseling, individual drug reminders, recommendations for healthy lifestyles, cardiovascular education about AMI, and follow-up reminders four times a week, while the control group will only receive cardiology knowledge and follow-up reminders four times a week. Mobile health tools (WeChat applet) were developed through cooperation with a technology company to establish appropriately. Trained research nurses will conduct the follow up in the 4th, 8th, 12th months by telephone or face-to-face visit. All the adverse events will be collected through a self-reported section in the mobile health tools. The study will evaluate the acceptability, utility of the intervention based on Internet consulting management.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Maoming People's Hospital, Dongguan People's Hospital, First People's Hospital, Shunde China, Guangzhou Panyu Central 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
- NCT04119726
- Sponsor's protocol ID
- GDREC2018328H
- Status last verified
- Oct 2019
- First submitted
- 7 Oct 2019
- Last updated
- 10 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study Design of a Mobile Health (mHealth) Technology Associated Improvement of Drug Adherence in Patients With Acute Myocardial Infarction and Protocol for the Randomized, Controlled Trial（RESCIND-3)
- ClinicalTrials.gov ID
- NCT04119726
- Acronym / sponsor ID
- GDREC2018328H
- Conditions
- Coronary Artery Disease
- Keywords
- Mobile health, Acute myocardial infarction, Cardioprotective medications, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Collaborators
- Maoming People's Hospital, Dongguan People's Hospital, First People's Hospital, Shunde China, Guangzhou Panyu Central Hospital
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 8 Oct 2019 (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.
The RESCIND-3 study is a multicenter, double-blind, randomized controlled trial. It will be conducted in the departments of cardiology in 5 hospitals. Guangdong General Hospital ethics review board approved the study's design. 400 patients with AMI on admission will be continuously enrolled and randomly allocated to either the control or intervention group. The intervention group will receive internet-based counseling, individual drug reminders, recommendations for healthy lifestyles, cardiovascular education about AMI, and follow-up reminders four times a week, while the control group will only receive cardiology knowledge and follow-up reminders four times a week. Mobile health tools (WeChat applet) were developed through cooperation with a technology company to establish appropriate It will be blinding for investigators but all participants will be aware of whether their intervention is the 'experimental' treatment. Trained research nurses will conduct the follow up in the 4th, 8th, 12th months by telephone or face-to-face visit. All the adverse events will be collected through a self-reported section in the mobile health tools. The study will evaluate the acceptability, utility of the intervention based on Internet consulting management.
Detailed description
Background：Antithrombotic drugs, β-blockers, statins and angiotensin converting enzyme inhibitor (ACEI)/angiotensin II receptor blockers (ARB) are recommended for patients with acute myocardial infarction(AMI). However, discontinuation of the drugs was associated with higher mortality. Few studies focused on the improvement of drug compliance through mHealth tools.
Objective：To investigate whether internet-based counseling could improve drug(Antithrombotic drugs, β-blockers, statins an ACEI/ARB) compliance following percutaneous coronary intervention(PCI) among patients with AMI within 1year's follow-up.
Study design：The study is a multicenter, randomized, prospective, double-blinded study. A total of 400 AMI patients following PCI will be randomized to intervention group or control group in addition to usual post-MI care. The intervention group will receive internet-based counseling, personalized reminders(drug information, healthy lifestyles advise) and educational message (cardiovascular knowledge and follow-up reminders) four times a week. It will be only usual messages (cardiovascular knowledge and follow-up reminders) supported four times a week in the control group. The primary endpoint is the discontinuation rate of coronary heart disease secondary prevention drugs (antiplatelet, ACEI/ARB, beta-blockers, and statins). The second endpoints include drug adherence scores assessed by the proportion of days covered(PDC) and major adverse cardiovascular events. Both groups will be followed up within 1year after PCI.
Summary：The multicentre randomized trial(RESCIND-3) will provide new evidence of the effectiveness of mHealth tools on improving 12-month drug compliance following PCI among patients with AMI.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 400 patients with AMI on admission will be continuously enrolled and randomly allocated to either the control or intervention group. The intervention group will receive internet-based counseling, individual drug reminders, recommendations for healthy lifestyles, cardiovascular education about AMI, and follow-up reminders four times a week, while the control group will only receive cardiology knowledge and follow-up reminders four times a week. Mobile health tools (WeChat applet) were developed through cooperation with a technology company to establish appropriately. Trained research nurses will conduct the follow up in the 4th, 8th, 12th months by telephone or face-to-face visit. All the adverse events will be collected through a self-reported section in the mobile health tools. The study will evaluate the acceptability, utility of the intervention based on Internet consulting management.
| Arm | Type | Receives |
|---|---|---|
| Control Group | Other | Behavioral: Usual Text MessagesThe control group will receive a simplified tool including only the education message. The methodology will ensure that potential confounders by differences in nonspecific support and attention could be adjusted. Regular messages about prevention and cure of CHD will be sent to both groups four times a week. The short texts will be selected from the guidelines in China to avoid misinformation. There are also some pictures or videos that help patients change their behavior. Patients will be followed up for 4/8/12 months after admission through mHealth tools or telephone. |
| Intervention Group | Experimental | Behavioral: Usual Text Messages, Behavioral: Personalized reminders, Behavioral: Internet-based counsellingThe intervention group will receive a complete social medial tool (web-based application ) installed on mobile phones including general education about coronary disease、personalized reminders and internet-based counseling. Patients will be followed up for 4/8/12 months after admission through mHealth tools or telephone. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged ≥18 years
- Diagnosed with acute myocardial infarction
- Taking four kinds of cardioprotective medications(antiplatelet, ACEI/ARB, beta-blockers, and statins)
- Wechat and smartphone users
- Provide written informed consent
Key exclusion criteria (4 listed)
- Pregnancy
- Malignant tumor or end-stage disease with a life expectancy of <1 year
- Unable to use mobile phone network applet
- Refuse to sign the informed consent
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 MessagesRegular messages about prevention and cure of CHD will be sent to both groups four times a week. The short texts will be selected from the guidelines in China to avoid misinformation. There are also some pictures or videos that help patients change their behaviour. | Behavioural | Control Group, Intervention Group |
| Personalized remindersPersonal information, life behavior and risk factors will be registered when patients are enrolled. According to the baseline information, personalized knowledge will be sent to patients in the intervention group. Besides, patients will receive drug information and regular medication adherence reminders daily according to patients' baseline prescription drugs and modifications. | Behavioural | Intervention Group |
| Internet-based counsellingThe internet-based counselling is the key module of social media in the intervention group. The consultation content mainly includes the feedback of coronary heart disease secondary prevention drug compliance, the feedback of risk factor level control, the feedback of life and behaviour habits, the feedback of adverse events, the feedback of health education knowledge improvement, the reminders of data upload, behaviour change, and health education learning. When the patient has questions or discomfort during the medication, they can consult the applet and the applet will perform internet-based answers on the large database built by cardiologists. Meanwhile, social media will upload the question of consultation and report to the doctor according to individual differences in disease. If the patient is not satisfied with the auto-response, the patient can further consult his doctor and the doctor's response will be collected to improve the auto-response database | Behavioural | Intervention Group |
Primary outcome
Rate of discontinuation of drug
Time frame: 1 year
The discontinuation rate of each 4 kinds of coronary heart disease secondary prevention drug (antiplatelet drugs, ACEI/ARB, beta-blockers, and statins) without any professional permission. The continuous withdrawal time will be divided into three groups: ≤7 days, 8-30 days, more than 30 days.
4 secondary outcomes
Acute myocardial infarction
Time frame: 1 year
Medication discontinuance
Time frame: 1 year
Good drug compliance
Time frame: 1 year
Number of Participants with Major Adverse Cardiovascular Events. Target vascular revascularization (TVR)
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 10 Oct 2019.
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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 Internet-based counselling in people with Coronary Artery 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 5 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 10 Oct 2019. 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 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?
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 10 Oct 2019.