Affect of Health Education on Statins Medication Persistence and ClinicaL Prognosis of Ischemic Stroke Patients (HELP)

yongjun wang

Status: Completed

Conditions: Ischemic Stroke

Treatments: Behavioral: conventional health education; Behavioral: multiple health education interventions

Study type: Interventional

Funder types: Other

Identifiers

NCT02140658

TTYY20140312

Details and patient eligibility

About

The purpose of this study is to assess the affect of multiple health education interventions for statins medication Persistence and clinical prognosis of ischemic stroke patients at 3, 6 and 12 months.

Full description

The study is a prospective, multicenter, hospital-based study on secondary prevention for patients with ischemic cerebrovascular diseases between May 2014 and June 2015. Physicians from 24 hospitals in Beijing underwent a standard secondary prevention training of ischemic cerebrovascular diseases by professional training, instruction manuals, stratification management software. In order to improve the persistence of taking preventive secondary medicine, IS patients from these 24 hospitals received healthy education through manuals and Digital Video Disc about health education during hospitalization and acquired secondary preventive knowledge of ischemic cerebrovascular diseases through regular health education messages during 6 months after discharge. Patients with IS from other 6 hospitals were used as a control, and no such intervention was given to them.

Telephone follow-up was performed at 3 months, 6 months, and 1 year after the onset of cerebral infarction, during which the use of antiplatelet and statins drugs and recurrence of IS were recorded. Patients who took antiplatelet drugs or statins at three follow-ups were regarded as persistent antiplatelet drugs or statins taking within one year after the onset of the disease. The main prognostic indicator was the recurrence of IS and persistence of statins medication within 1 year, and the main purpose was to explore the impact of persistent statins use on IS recurrence.

Enrollment: 3,111 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adult subjects (male or female ≥18 years);
2. Acute ischemic stroke occured within 14 days of symptoms onset
3. Blood low density lipoprotein (LDL) ≧100mg/dl（2.59mmol/L）
4. Patients were prescribed statins at discharge
5. Patients signed informed consent
6. Patients have a cell phone and have the ability to receive and view messages

Exclusion criteria

1. Non-cerebrovascular events or hemorrhagic stroke
2. Patients have serious heart, liver, kidney dysfunction or coagulation disorders
3. Patients have circumstances that may affect the follow-up such as disturbance of consciousness, severe depression or other mental disorders, aphasia
4. Modified Rankin Scale score at discharge ≥3
5. Patients with severe vision or vision field impairment which may affect patients to read message in cell phone
6. Those who are participating in other clinical trials
7. Those who can not guarantee with the completion of 6 month follow-up after enrollment

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3,111 participants in 2 patient groups, including a placebo group

multiple health education interventions

Active Comparator group

Description:

The first group will receive health education manuals and Digital Video Disc (DVD) during hospitalization and regular health education messages during 6 months after discharge.

Treatment:

Behavioral: multiple health education interventions

conventional health education

Placebo Comparator group

Description:

The second group will receive conventional health education during hospitalization except health education manuals, regular health education messages and Digital Video Disc (DVD)

Treatment:

Behavioral: conventional health education