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

Not Applicable

Completed

• Conditions: Ischemic Stroke
• Interventions: Behavioral: multiple health education interventions; Behavioral: conventional health education

• Registration Number: NCT02140658
• Lead Sponsor: yongjun wang

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-05-05
• Study First Submitted QC: 2014-05-14
• Study First Posted: 2014-05-16
• Primary Completion: 2015-06
• Study Completion: 2015-09
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-09
• Last Update Posted: 2018-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3111

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
multiple health education interventions	multiple health education interventions	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.
conventional health education	conventional health education	The second group will receive conventional health education during hospitalization except health education manuals, regular health education messages and Digital Video Disc (DVD)

Primary Outcome Measures

Name	Time	Method
Proportion of patients who continued taking statins drugs at three months after stroke onset.	3 months after stroke onset	Statins Medication persistence at 3 months. Patients who took statins at three months follow-up were regarded as persistent during three months.
Proportion of patients who continued taking statins drugs in 1 year after stroke onset.	1 year after stroke onset	Statins Medication persistence in 1 year: Patients who took statins at 3, 6 and 12 months follow-up were regarded as persistent during one year after stroke onset.
Recurrence of ischemic stroke in six months after stroke onset	6 months after stroke onset	Recurrence of ischemic stroke was defined as a new focal neurological deficit of vascular origin lasting \>24 hours and without hemorrhage on computed tomography or MRI of the brain.
Proportion of patients who continued taking statins drugs at six months after stroke onset.	6 months after stroke onset	Statins Medication persistence at 6 months.Patients who took statins at six months follow-up were regarded as persistent at six months.
Proportion of patients who continued taking statins drugs at 12 months after stroke onset.	12 months after stroke onset	Statins Medication persistence at 12 months.Patients who took statins at twelve months follow-up were regarded as persistent at twelve months.
Recurrence of ischemic stroke in three months after stroke onset	3 months after stroke onset	Recurrence of ischemic stroke was defined as a new focal neurological deficit of vascular origin lasting \>24 hours and without hemorrhage on computed tomography or MRI of the brain.
Recurrence of ischemic stroke in 12 months after stroke onset	12 months after stroke onset	Recurrence of ischemic stroke was defined as a new focal neurological deficit of vascular origin lasting \>24 hours and without hemorrhage on computed tomography or MRI of the brain.

Secondary Outcome Measures

Name	Time	Method
Percentage of patients with 3-month poor clinical prognosis (including Death or Nonfatal myocardial infarction or Nonfatal hemorrhagic stroke or Severe disabilities) as a cluster and evaluated individually	3 months after stroke onset	Death included Vascular death and non-vascular death; Severe disabilities was defined as modified Rankin Scale ≥4
Percentage of patients with 12-month poor clinical prognosis (including Death or Nonfatal myocardial infarction or Nonfatal hemorrhagic stroke or Severe disabilities) as a cluster and evaluated individually	12 months after stroke onset	Death included Vascular death and non-vascular death; Severe disabilities was defined as modified Rankin Scale ≥4
Percentage of patients with 6-month poor clinical prognosis (including Death or Nonfatal myocardial infarction or Nonfatal hemorrhagic stroke or Severe disabilities) as a cluster and evaluated individually	6 months after stroke onset	Death included Vascular death and non-vascular death; Severe disabilities was defined as modified Rankin Scale ≥4

Trial Locations

Locations (1)

Beijing Tian Tan Hospital, Capital Medical University; 🇨🇳 Beijing, China