Intensive Education on Lipid Management

NCT01925079 | Unknown

• 1 other identifier: ACS-lipid-2013
• Study Type: interventional
• Target: 2,568
• Locations: 1 country
• Sites: 5

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.

Conditions

Acute Coronary Syndrome

Keywords

acute coronary syndrome; statins; LDL-C; intensive education

Outcome Measures

Primary Outcomes (1)

• LDL-C target achieving rate

  at Week 24 post-discharge

Secondary Outcomes (8)

• 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

  at Week 24 post-discharge

• statin compliance

  at Week 12 post-discharge

• statin compliance

  at Week 24 post-discharge

Other Outcomes (1)

• the major adverse cardiovascular events

  at 24 weeks follow up

Study Arms (2)

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.

Behavioral: Intensive Education

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.

Other: Control

Interventions

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: 1. Routine education at discharge. 2. 4 education brochures will be delivered to patients. 3. Calendar with healthy tips will be delivered to patients before discharge. 4. A follow-up brochure with medical expert letter. 5. A total of 24 specific short messages for ACS will be developed and sent to patients (one short message per week). 6. Telephone follow ups will be performed according to a standard communication document. At discharge, patients will be given a brochure for future follow up.

Intensive Educational Group

Control OTHER

Statin Treatment：The recommended dosage of atorvastatin will be adjusted at the physician's discretion. Patient education: 1. Routine education at discharge. 2. A follow-up brochure without medical expert letter. At discharge, patients will be given a brochure for future follow up.

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• The age of patient enrolled will be ≥18 years old;
• The patient is able to understand and complete questionnaire.
• The patients agree to accept follow-up visits, and willing to participate in patient education courses and sign informed consent form.

You may not qualify if:

• 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.
• The patient who uses other statins except Lipitor® when discharged from the hospital;
• Cardiac function class of the patient is class IV(NYHA);
• The patient has a malignant tumor;
• The patient has a severe arrhythmia.

Sponsors & Collaborators

• Junbo Ge: lead
• Fujian Medical University: collaborator
• The Second Affiliated Hospital of Harbin Medical University: collaborator
• Xi'an Jiaotong University: collaborator
• The Luhe Teaching Hospital of the Capital Medical University: collaborator

Study Sites (5)

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Location

The 2nd affiliated hospital of harbin medical university

Harbin, Heilongjiang, 150001, China

Location

Xi'an Jiaotong University College of Medicine

Xi’an, Shanxi, 710061, China

Location

The Luhe Teaching Hospital of the Capital Medical University

Beijing, China

Location

Shanghai Zhongshan Hospital

Shanghai, 200032, China

Location

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Junbo Ge, Professor

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bingqing Huang

CONTACT

86-13816586495; huang.bingqing@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 15, 2013
• First Posted: August 19, 2013
• Study Start: August 1, 2013
• Primary Completion: February 1, 2015
• Study Completion: June 1, 2015
• Last Updated: August 20, 2013

Record last verified: 2013-08

Locations

CN (5)