Intensive Education on Lipid Management

Not Applicable

• Conditions: Acute Coronary Syndrome
• Interventions: Behavioral: Intensive Education; Other: Control

• Registration Number: NCT01925079
• Lead Sponsor: Junbo Ge

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-08
• Study Start: 2013-08
• Study First Submitted: 2013-08-15
• Study First Submitted QC: 2013-08-15
• Last Update Submitted: 2013-08-18
• Study First Posted: 2013-08-19
• Last Update Posted: 2013-08-20
• Primary Completion: 2015-02
• Study Completion: 2015-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2568

Inclusion Criteria

1. The patients admitted to the hospital with a diagnosis of ACS including those for first consulting or with recurrence. The patient was prescribed atorvastatin (Lipitor®) by physicians in hospital;
2. The age of patient enrolled will be ≥18 years old;
3. The patient is able to understand and complete questionnaire.
4. The patients agree to accept follow-up visits, and willing to participate in patient education courses and sign informed consent form.

Exclusion Criteria

1. The patient has contraindications to statins, such as active hepatic disease, patient has a history of intolerance or hypersensitivity to statins or has a history of prior rhabdomyolysis on a statin.
2. The patient who uses other statins except Lipitor® when discharged from the hospital;
3. Cardiac function class of the patient is class IV(NYHA);
4. The patient has a malignant tumor;
5. The patient has a severe arrhythmia.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intensive Educational Group	Intensive Education	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.
Control Group	Control	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.

Primary Outcome Measures

Name	Time	Method
LDL-C target achieving rate	at Week 24 post-discharge

Secondary Outcome Measures

Name	Time	Method
the proportions of patients with statin persistence	at Week 24 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	at Week 24 post-discharge	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.
LDL-C target achieving rate	at Week 12 post-discharge

Trial Locations

Locations (5)

Xi'an Jiaotong University College of Medicine; 🇨🇳 Xi'an, Shanxi, China

Fujian Medical University Union Hospital; 🇨🇳 Fuzhou, Fujian, China

The 2nd affiliated hospital of harbin medical university; 🇨🇳 Harbin, Heilongjiang, China

The Luhe Teaching Hospital of the Capital Medical University; 🇨🇳 Beijing, China

Shanghai Zhongshan Hospital; 🇨🇳 Shanghai, China