Stable Chronic AnginaCHIPCHATNCT04795505
Effect of Tertiary A-level Hospital Remote Intervention on MACCE, Adherence to Drugs and Risk Factors Control in Patients With Stable Coronary Artery Disease Compared With Traditional Community Hospital Follow-up
An observational study of Stable Chronic Angina and Ischemic Heart Disease, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.
Trial summary
The study was a multicenter, two-arm, parallel, open label, prospective study intended for to compare effect of offline community hospital intervention on adherence to drugs and risk factors control in patients with stable coronary artery disease compared with tertiary A-level hospital WeChat-based intervention. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Stable Chronic Angina, Ischemic Heart Disease, Acute Coronary Syndrome
- What is being tested?
- Intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,424 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2018to 1 Jan 2023
- Phase
- Observational
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants are screened from several community hospitals and tertiary-A hospitals in Beijing
Who may be able to join
- aged between 18-99 years
- diagnosed with SCAD according to guidelines by coronary CTA or coronary angiography (including stable angina, ischemic cardiomyopathy, and the stable course after acute coronary syndrome)
- have sufficient Chinese language proficiency to reading, speaking and listening
- live with at least one caregiver or guardian in the household
- presence of stable hemodynamics without using vasopressor
- able to individually consent
- not participating in any other clinical trial
Who cannot join
- unable to provide informed consent
- unable to be involved in clinical follow up and treatment
- suffered comorbidity with a life expectancy of less than 1 year
- have contra-indication to cardiac rehabilitation
- acute coronary syndrome
Trial locations and contacts
1 site in 1 country.
China1 site
Fuwai Hospital, Chinese Academy of Medical Science; National Center for Cardiovascular Diseases
Beijing, Beijing Municipality, 100000
About this study
The study was a multicenter, two-arm, parallel, open label, prospective study intended for to compare effect of offline community hospital intervention on adherence to drugs and risk factors control in patients with stable coronary artery disease compared with tertiary A-level hospital WeChat-based intervention.
Read the detailed description
Objective: This study is intended for to compare effect of offline community hospital intervention on adherence to drugs and risk factors control in patients with stable coronary artery disease compared with tertiary A-level hospital WeChat-based intervention.
Study design: The study was a multicenter, two-arm, parallel, open label, prospective study that evaluated a WeChat-based intervention offered by tertiary A-level hospital with 1 year of follow-up.
Study intervention: All patients received lifestyle intervention and drug adjustment at 1 month, 3 months, 6 months and 1 year follow-up. In the control group, the subsequent visit was through an offline outpatient clinic at 4 different community hospitals. Participants in this group received standard outpatient cardiology follow-up with formal cardiac rehabilitation and secondary prevention. While in the intervention group, the subsequent visit was through WeChat-based online consultations.
Outcome measures: The primary outcome was MACCE. Secondary outcome included blood pressure, heart rates, smoking cessation, drinking cessation, body mass index, and medications adherence.
Statistical analysis: Values of analyzed endpoints between intervention group and control group will be compared according to the analysis plan. We'll follow a prespecified analysis plan and subgroup analysis will be conducted accordingly.
- Being tested
- Intervention, Control
- Medical subject headings
- Angina, Stable, Myocardial Ischemia, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionBehavioural
The subsequent visit was through WeChat-based online consultations. Follow-up, assessments and feedback were done at each visit. After follow-up, medication adherence and risk factor modification status were assessed, then individualized feedback, encouragement and recommendations were provided.
ControlBehavioural
The subsequent visit was through an offline outpatient clinic at 4 different community hospitals. Participants in this group received standard outpatient cardiology follow-up with formal cardiac rehabilitation and secondary prevention
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | A tertiary A-level hospital WeChat-based intervention Receives: Behavioral: Intervention | |
| Control group | Traditional community hospital intervention Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
MACCE
acute myocardial infarction, acute heart failure, stroke, rehospitalization for cardiovascular event, death from a cardiovascular cause and unplanned revascularization
Measured: 1 year
Secondary outcomes (8)
blood pressure
BP was measured twice by an electronic device after 10 min of seated rest and calculated as the mean of 2 measurements.
Measured: 1 year
heart rates
standard protocol
Measured: 1 year
smoking cessation
self-reported
Measured: 1 year
drinking cessation
self-reported
Measured: 1 year
body mass index
standard protocol
Measured: 1 year
medications adherence
self-reported
Measured: 1 year
LDL
standard protocol
Measured: 1 year
HbA1c
standard protocol
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 posted12 Mar 2021
- Study start1 Sep 2018
- Primary completion1 Jan 2023
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Stable Chronic AnginaStudies of the same condition, open and under way.
- More trials run by Chinese Academy of Medical Sciences, Fuwai 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,424 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weihua Song, Chinese Academy of Medical Sciences, Fuwai Hospital
- Investigators
- Weihua Song, MD, Principal investigator, Fuwai Hospital, Chinese Academy of Medical Science; National Center for Cardiovascular Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04795505
- Sponsor's protocol ID
- CHIPCHAT
- Acronym
- CHIPCHAT
- Status last verified
- Feb 2023
- First submitted
- 9 Mar 2021
- Last updated
- 16 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zheng X, Spatz ES, Bai X, Huo X, Ding Q, Horak P, Wu X, Guan W, Chow CK, Yan X, Sun Y, Wang X, Zhang H, Liu J, Li J, Li X, Spertus JA, Masoudi FA, Krumholz HM. Effect of Text Messaging on Risk Factor Management in Patients With Coronary Heart Disease: The CHAT Randomized Clinical Trial. Circ Cardiovasc Qual Outcomes. 2019 Apr;12(4):e005616. doi: 10.1161/CIRCOUTCOMES.119.005616.
PubMed 30998400Yu C, Liu C, Du J, Liu H, Zhang H, Zhao Y, Yang L, Li X, Li J, Wang J, Wang H, Liu Z, Rao C, Zheng Z; MISSION-2 Collaborative Group. Smartphone-based application to improve medication adherence in patients after surgical coronary revascularization. Am Heart J. 2020 Oct;228:17-26. doi: 10.1016/j.ahj.2020.06.019. Epub 2020 Jul 4.
PubMed 32745732Chen X, Zhou X, Li H, Li J, Jiang H. The value of WeChat application in chronic diseases management in China. Comput Methods Programs Biomed. 2020 Nov;196:105710. doi: 10.1016/j.cmpb.2020.105710. Epub 2020 Aug 14.
PubMed 32858284Shi B, Liu X, Dong Q, Yang Y, Cai Z, Wang H, Yin D, Wang H, Dou K, Song W. The Effect of a WeChat-Based Tertiary A-Level Hospital Intervention on Medication Adherence and Risk Factor Control in Patients With Stable Coronary Artery Disease: Multicenter Prospective Study. JMIR Mhealth Uhealth. 2021 Oct 27;9(10):e32548. doi: 10.2196/32548.
PubMed 34569467
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Tertiary A-level Hospital Remote Intervention on MACCE, Adherence to Drugs and Risk Factors Control in Patients With Stable Coronary Artery Disease Compared With Traditional Community Hospital Follow-up
- ClinicalTrials.gov ID
- NCT04795505
- Acronym / sponsor ID
- CHIPCHAT / CHIPCHAT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,424 participants (actual)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 12 Mar 2021 (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 study was a multicenter, two-arm, parallel, open label, prospective study intended for to compare effect of offline community hospital intervention on adherence to drugs and risk factors control in patients with stable coronary artery disease compared with tertiary A-level hospital WeChat-based intervention.
Detailed description
Objective: This study is intended for to compare effect of offline community hospital intervention on adherence to drugs and risk factors control in patients with stable coronary artery disease compared with tertiary A-level hospital WeChat-based intervention.
Study design: The study was a multicenter, two-arm, parallel, open label, prospective study that evaluated a WeChat-based intervention offered by tertiary A-level hospital with 1 year of follow-up.
Study intervention: All patients received lifestyle intervention and drug adjustment at 1 month, 3 months, 6 months and 1 year follow-up. In the control group, the subsequent visit was through an offline outpatient clinic at 4 different community hospitals. Participants in this group received standard outpatient cardiology follow-up with formal cardiac rehabilitation and secondary prevention. While in the intervention group, the subsequent visit was through WeChat-based online consultations.
Outcome measures: The primary outcome was MACCE. Secondary outcome included blood pressure, heart rates, smoking cessation, drinking cessation, body mass index, and medications adherence.
Statistical analysis: Values of analyzed endpoints between intervention group and control group will be compared according to the analysis plan. We'll follow a prespecified analysis plan and subgroup analysis will be conducted accordingly.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | – | Behavioral: InterventionA tertiary A-level hospital WeChat-based intervention |
| Control group | – | Behavioral: ControlTraditional community hospital intervention |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants are screened from several community hospitals and tertiary-A hospitals in Beijing
Key inclusion criteria (7 listed)
- aged between 18-99 years
- diagnosed with SCAD according to guidelines by coronary CTA or coronary angiography (including stable angina, ischemic cardiomyopathy, and the stable course after acute coronary syndrome)
- have sufficient Chinese language proficiency to reading, speaking and listening
- live with at least one caregiver or guardian in the household
- presence of stable hemodynamics without using vasopressor
Key exclusion criteria (5 listed)
- unable to provide informed consent
- unable to be involved in clinical follow up and treatment
- suffered comorbidity with a life expectancy of less than 1 year
- have contra-indication to cardiac rehabilitation
- acute coronary syndrome
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 |
|---|---|---|
| InterventionThe subsequent visit was through WeChat-based online consultations. Follow-up, assessments and feedback were done at each visit. After follow-up, medication adherence and risk factor modification status were assessed, then individualized feedback, encouragement and recommendations were provided. | Behavioural | Intervention group |
| ControlThe subsequent visit was through an offline outpatient clinic at 4 different community hospitals. Participants in this group received standard outpatient cardiology follow-up with formal cardiac rehabilitation and secondary prevention | Behavioural | Control group |
Primary outcome
MACCE
Time frame: 1 year
acute myocardial infarction, acute heart failure, stroke, rehospitalization for cardiovascular event, death from a cardiovascular cause and unplanned revascularization
8 secondary outcomes
blood pressure
Time frame: 1 year
heart rates
Time frame: 1 year
smoking cessation
Time frame: 1 year
drinking cessation
Time frame: 1 year
body mass index
Time frame: 1 year
medications adherence
Time frame: 1 year
LDL
Time frame: 1 year
HbA1c
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
- Background: PubMed 30998400Zheng X, Spatz ES, Bai X, Huo X, Ding Q, Horak P, Wu X, Guan W, Chow CK, Yan X, Sun Y, Wang X, Zhang H, Liu J, Li J, Li X, Spertus JA, Masoudi FA, Krumholz HM. Effect of Text Messaging on Risk Factor Management in Patients With Coronary Heart Disease: The CHAT Randomized Clinical Trial. Circ Cardiovasc Qual Outcomes. 2019 Apr;12(4):e005616. doi: 10.1161/CIRCOUTCOMES.119.005616.
- Background: PubMed 32745732Yu C, Liu C, Du J, Liu H, Zhang H, Zhao Y, Yang L, Li X, Li J, Wang J, Wang H, Liu Z, Rao C, Zheng Z; MISSION-2 Collaborative Group. Smartphone-based application to improve medication adherence in patients after surgical coronary revascularization. Am Heart J. 2020 Oct;228:17-26. doi: 10.1016/j.ahj.2020.06.019. Epub 2020 Jul 4.
- Background: PubMed 32858284Chen X, Zhou X, Li H, Li J, Jiang H. The value of WeChat application in chronic diseases management in China. Comput Methods Programs Biomed. 2020 Nov;196:105710. doi: 10.1016/j.cmpb.2020.105710. Epub 2020 Aug 14.
- Derived from this study: PubMed 34569467Shi B, Liu X, Dong Q, Yang Y, Cai Z, Wang H, Yin D, Wang H, Dou K, Song W. The Effect of a WeChat-Based Tertiary A-Level Hospital Intervention on Medication Adherence and Risk Factor Control in Patients With Stable Coronary Artery Disease: Multicenter Prospective Study. JMIR Mhealth Uhealth. 2021 Oct 27;9(10):e32548. doi: 10.2196/32548.
- Number of monthly active WeChat users from 2nd quarter 2011 to 2nd quarter 2020(in millions)Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Weihua Song, MD principal investigator
Fuwai Hospital, Chinese Academy of Medical Science; National Center for Cardiovascular Diseases
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stable Chronic Angina and Ischemic Heart Disease, run by Chinese Academy of Medical Sciences, Fuwai 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 7 inclusion and 5 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: finished, as of the sponsor's last update on 16 Feb 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MACCE (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 NCT04795505, which also lists 4 linked publications.
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 16 Feb 2023.