Percutaneous Coronary InterventionNCT03059784
APP-based Multifaceted Management After PCI
A study testing APP-based multifaceted management in people with Percutaneous Coronary Intervention, run by Chinese Academy of Medical Sciences, Fuwai Hospital.
Trial summary
High rates of recurrent cardiovascular events and readmission after percutaneous coronary intervention (PCI) are important issues. Guidelines emphasize rehabilitation and secondary prevention. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Percutaneous Coronary Intervention
- What is being tested?
- APP-based multifaceted management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,100 participants
- Where
- No sites listed yet
- Study dates
- Mar 2017to Aug 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients who have received percutaneous coronary intervention and are discharged alive in the study centers;
- patients who are able to use APP;
- patients who provide informed consent.
Who cannot join
- patients who are not able to use APP;
- dementia;
- mental disturbed;
- patients who are not willing to receive management and follow up.
Trial locations and contacts
No sites are listed yet.
HAIYAN XU contact
About this study
Official title: Mobile Application-based Multifaceted Management to Improve Long-term Care After Percutaneous Coronary Intervention
High rates of recurrent cardiovascular events and readmission after percutaneous coronary intervention (PCI) are important issues. Guidelines emphasize rehabilitation and secondary prevention. But many patients are lack of effective management after PCI.This study is aimed to examine the effect of mobile application (APP)-based multifaceted management on the improvement of long-term care after PCI.
Read the detailed description
This is a cluster-randomized controlled trial to evaluate the effect of APP-based multifaceted management strategy on improvement of long-term care for medication adherence,risk factor control, and reduction of adverse events, readmission rate and mortality after PCI.It includes knowledge education, medication reminder,advice provision, support to change lifestyle behaviors. The program is interactive between care provider and patients. A total of 20 wards will be randomly assigned to intervention or usual care.Anticipated 1100 patients after PCI will be participated in the trial. All the participants will be followed up until 12 months.
- Conditions
- Percutaneous Coronary Intervention
- Being tested
- APP-based multifaceted management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APP-based multifaceted managementOther
Patients after PCI will be regularly given education materials, medication reminders, life-style behaviors instruction through APP. Cardiologists can interact with patients on advice provision and clinical support after discharge through APP.
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | APP-based multifaceted management, including sending education material, everyday medication reminder, giving risk factor control support, clinical support to patients after PCI through APP. Receives: Other: APP-based multifaceted management |
| control | No intervention | usual care without APP |
What is being measured
The primary outcome is the main question the study is designed to answer.
evidence-based medication adherence (the proportion of participants taking 3 medications (aspirin, P2Y12 receptor inhibitor, statin) without contraindications)
the proportion of participants taking 3 medications (aspirin, P2Y12 receptor inhibitor, statin) without contraindications
Measured: at 12 months after PCI
Secondary outcomes (3)
rate of LDL-C achieving target
rate of LDL-C achieving target based on guideline
Measured: at 12 months after PCI
rate of systolic blood pressure achieving target
rate of systolic blood pressure achieving target based on guideline
Measured: at 12 months after PCI
readmission rate
readmission rate after PCI
Measured: 12 months after PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study startMar 2017 (estimated)
- Primary completionJul 2018 (estimated)
- Study completionAug 2018 (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 Percutaneous Coronary InterventionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yongjian Wu, Chinese Academy of Medical Sciences, Fuwai Hospital
- Investigators
- Yongjian Wu, Study chair, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03059784
- Sponsor's protocol ID
- 2016-ZX16
- Status last verified
- Feb 2017
- First submitted
- 17 Feb 2017
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: management methods,outcomes including medication use, events of patients can be available on request.
Publications
Tian M, Ajay VS, Dunzhu D, Hameed SS, Li X, Liu Z, Li C, Chen H, Cho K, Li R, Zhao X, Jindal D, Rawal I, Ali MK, Peterson ED, Ji J, Amarchand R, Krishnan A, Tandon N, Xu LQ, Wu Y, Prabhakaran D, Yan LL. A Cluster-Randomized, Controlled Trial of a Simplified Multifaceted Management Program for Individuals at High Cardiovascular Risk (SimCard Trial) in Rural Tibet, China, and Haryana, India. Circulation. 2015 Sep 1;132(9):815-24. doi: 10.1161/CIRCULATIONAHA.115.015373. Epub 2015 Jul 17.
PubMed 26187183
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Application-based Multifaceted Management to Improve Long-term Care After Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT03059784
- Acronym / sponsor ID
- 2016-ZX16
- Conditions
- Percutaneous Coronary Intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,100 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Study start
- Mar 2017 (estimated)
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 23 Feb 2017 (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.
High rates of recurrent cardiovascular events and readmission after percutaneous coronary intervention (PCI) are important issues. Guidelines emphasize rehabilitation and secondary prevention. But many patients are lack of effective management after PCI.This study is aimed to examine the effect of mobile application (APP)-based multifaceted management on the improvement of long-term care after PCI.
Detailed description
This is a cluster-randomized controlled trial to evaluate the effect of APP-based multifaceted management strategy on improvement of long-term care for medication adherence,risk factor control, and reduction of adverse events, readmission rate and mortality after PCI.It includes knowledge education, medication reminder,advice provision, support to change lifestyle behaviors. The program is interactive between care provider and patients. A total of 20 wards will be randomly assigned to intervention or usual care.Anticipated 1100 patients after PCI will be participated in the trial. All the participants will be followed up until 12 months.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Other: APP-based multifaceted managementAPP-based multifaceted management, including sending education material, everyday medication reminder, giving risk factor control support, clinical support to patients after PCI through APP. |
| control | No intervention | –usual care without APP |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- patients who have received percutaneous coronary intervention and are discharged alive in the study centers;
- patients who are able to use APP;
- patients who provide informed consent.
Key exclusion criteria (4 listed)
- patients who are not able to use APP;
- dementia;
- mental disturbed;
- patients who are not willing to receive management and follow up.
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 |
|---|---|---|
| APP-based multifaceted managementPatients after PCI will be regularly given education materials, medication reminders, life-style behaviors instruction through APP. Cardiologists can interact with patients on advice provision and clinical support after discharge through APP. | Other | intervention |
Primary outcome
evidence-based medication adherence (the proportion of participants taking 3 medications (aspirin, P2Y12 receptor inhibitor, statin) without contraindications)
Time frame: at 12 months after PCI
the proportion of participants taking 3 medications (aspirin, P2Y12 receptor inhibitor, statin) without contraindications
3 secondary outcomes
rate of LDL-C achieving target
Time frame: at 12 months after PCI
rate of systolic blood pressure achieving target
Time frame: at 12 months after PCI
readmission rate
Time frame: 12 months after PCI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
- Background: PubMed 26187183Tian M, Ajay VS, Dunzhu D, Hameed SS, Li X, Liu Z, Li C, Chen H, Cho K, Li R, Zhao X, Jindal D, Rawal I, Ali MK, Peterson ED, Ji J, Amarchand R, Krishnan A, Tandon N, Xu LQ, Wu Y, Prabhakaran D, Yan LL. A Cluster-Randomized, Controlled Trial of a Simplified Multifaceted Management Program for Individuals at High Cardiovascular Risk (SimCard Trial) in Rural Tibet, China, and Haryana, India. Circulation. 2015 Sep 1;132(9):815-24. doi: 10.1161/CIRCULATIONAHA.115.015373. Epub 2015 Jul 17.
- Individual participant dataSharing planned: Yes. management methods,outcomes including medication use, events of patients can be available on request.
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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.
HAIYAN XU contact
Yongjian Wu study chair
Chinese Academy of Medical Sciences, Fuwai Hospital
Questions about this trial
What is this clinical trial studying?
A study testing APP-based multifaceted management in people with Percutaneous Coronary Intervention, run by Chinese Academy of Medical Sciences, Fuwai Hospital.
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 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
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 HAIYAN XU (hyxu@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evidence-based medication adherence (the proportion of participants taking 3 medications (aspirin, P2Y12 receptor inhibitor, statin) without contraindications) (time frame: at 12 months after PCI). 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 NCT03059784, 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 23 Feb 2017.