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| Name | Class |
|---|---|
| Fujian Medical University | OTHER |
| The Second Affiliated Hospital of Harbin Medical University | OTHER |
| Xi'an Jiaotong University | OTHER |
| The Luhe Teaching Hospital of the Capital Medical University |
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Among the patients with coronary heart disease, those with ACS (acute coronary syndrome) are extremely high-risk patients. Therefore, management outside hospital, especially the regular administration of drugs, is vital to prevent the recurrence of cardiovascular events. However, most patients often fail to stay on a long-term administration regimen, especially the administration of statins. According to the statistics, the average duration adhered with statin in patients with ACS is less than 3 months, use of statin at hospital discharge was only 80% and 65% in 6 month, with a very low LDL-C control rate (about 11% at 6 months), which poses a threat to the recurrence rate of cardiovascular events in patients with ACS.
It was found in previous studies that there were many factors influencing patients' compliance, in which patients' refusing to take medicine accounted for a higher proportion. It suggests that patient had not recognized the importance of long-term administration. Therefore, it is extremely important for physicians to strengthen patient education and regular follow-up visits during disease management. Moreover, the effectiveness of patient education during chronic disease management has already been proved in some studies abroad, and the interventional effect of multiple patient education process outweighs that of single approach education.
Thus, we intend to conduct a randomized and controlled study to explore the effect of multi-channel intensive patient education on LDL-C target achieving rate and statin adherence in patients with ACS in China.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intensive Educational Group | Experimental | The Intensive Educational Group will receive 5 visits, including 2 visits via phone contacts. The expected dates for each visit will be stamped on the follow-up brochure for convenience. Patient education in this group includes routine education at discharge; 4 educational brochures, a calendar with health tips, and follow-up brochure with medical expert letter sent to patients at the day for discharge (baseline); and educational short messages through message platform once a week. Dosage and adjustment of statins, and concomitant medications in all the treated patients will be recorded. |
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| Control Group | Sham Comparator | The Control Group will receive 3 visits and receive care as per usual practice by the treating doctor and a follow-up brochure without medical expert letter. Dosage and adjustment of statins, and concomitant medications in all the treated patients will be recorded. Blood lipid panel (4 items), hepato-renal functions, and creatine kinase will be examined; while, Morisky 8-item questionnaire will be used to evaluate medication compliance at outpatient visits. In addition, the occurrence of major cardiovascular events and AE/SAE will be collected during the study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intensive Education | Behavioral | Statin Treatment:The investigator will be suggested to increase the dose of atorvastatin according to guideline if a patient's LDL-C does not achieve target level. Patient education:
At discharge, patients will be given a brochure for future follow up. |
| Measure | Description | Time Frame |
|---|---|---|
| LDL-C target achieving rate | at Week 24 post-discharge |
| Measure | Description | Time Frame |
|---|---|---|
| LDL-C target achieving rate | at Week 12 post-discharge | |
| the proportions of patients with statin persistence | at Week 12 post-discharge | |
| the proportions of patients with statin persistence |
| Measure | Description | Time Frame |
|---|---|---|
| the major adverse cardiovascular events | at 24 weeks follow up |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bingqing Huang | Contact | 86-13816586495 | huang.bingqing@zs-hospital.sh.cn |
| Name | Affiliation | Role |
|---|---|---|
| Junbo Ge, Professor | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Medical University Union Hospital | Fuzhou | Fujian | China |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| OTHER |
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| Control | Other | Statin Treatment:The recommended dosage of atorvastatin will be adjusted at the physician's discretion. Patient education:
At discharge, patients will be given a brochure for future follow up. |
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| at Week 24 post-discharge |
| statin compliance | at Week 12 post-discharge |
| statin compliance | at Week 24 post-discharge |
| the relationship of LDL-C target achieving rate and statin compliance | at Week 24 post-discharge |
| the discontinuation reason of statin therapy | at Week 24 post-discharge |
| the difference of LDL-C control rate and statin compliance | To find the difference of LDL-C control rate and statin compliance between pre-specified sub-groups: PCI or non-PCI/male or female/age (≥65) or not/ having medical insurance or not/dyslipidemia history or not /MI (myocardial infarction) or UA (unstable angina)/different risk level according to TIMI/ patients for first consulting or patients with recurrence/ have received statin in the last 3 months or not. | at Week 24 post-discharge |
| The 2nd affiliated hospital of harbin medical university | Harbin | Heilongjiang | 150001 | China |
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| Xi'an Jiaotong University College of Medicine | Xi’an | Shanxi | 710061 | China |
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| The Luhe Teaching Hospital of the Capital Medical University | Beijing | China |
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| Shanghai Zhongshan Hospital | Shanghai | 200032 | China |
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