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

Affect of Multiple Health Education Interventions on Statins Medication Persistence and ClinicaL Prognosis of Ischemic Stroke Patients (HELP): a Prospective Cohort Study

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.

Study Overview

• Status: Completed
• Conditions: Ischemic Stroke
• Intervention / Treatment: Behavioral: multiple health education interventions; Behavioral: conventional health education

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 Type: Interventional
• Enrollment (Actual): 3111
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100050
    • Beijing Tian Tan Hospital, Capital Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Behavioral: multiple health education interventions
Placebo Comparator: 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)	Behavioral: conventional health education

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients who continued taking statins drugs at three 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.	3 months after stroke onset
Proportion of patients who continued taking statins drugs at six 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.	6 months after stroke onset
Proportion of patients who continued taking statins drugs at 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.	12 months after stroke onset
Proportion of patients who continued taking statins drugs in 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.	1 year after stroke onset
Recurrence of ischemic stroke in three 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.	3 months after stroke onset
Recurrence of ischemic stroke in six 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.	6 months after stroke onset
Recurrence of ischemic stroke in 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.	12 months after stroke onset

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Death included Vascular death and non-vascular death; Severe disabilities was defined as modified Rankin Scale ≥4	3 months after stroke onset
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	Death included Vascular death and non-vascular death; Severe disabilities was defined as modified Rankin Scale ≥4	6 months after stroke onset
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	Death included Vascular death and non-vascular death; Severe disabilities was defined as modified Rankin Scale ≥4	12 months after stroke onset

Collaborators and Investigators

• Sponsor: yongjun wang
• Collaborators: Ministry of Science and Technology of the People´s Republic of China
• Investigators: Principal Investigator: yongjun wang, MD, Beijing Tian Tan Hospital, Capital Medical University, Beijing, China

Publications and helpful links

General Publications

• Crocker TF, Brown L, Lam N, Wray F, Knapp P, Forster A. Information provision for stroke survivors and their carers. Cochrane Database Syst Rev. 2021 Nov 23;11(11):CD001919. doi: 10.1002/14651858.CD001919.pub4.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2014
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: May 5, 2014
• First Submitted That Met QC Criteria: May 14, 2014
• First Posted (Estimate): May 16, 2014

Study Record Updates

• Last Update Posted (Actual): December 11, 2018
• Last Update Submitted That Met QC Criteria: December 9, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: outcome; ischemic stroke; Statins Medication Persistence
• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Infarction; Brain Infarction; Stroke; Ischemic Stroke; Ischemia; Cerebral Infarction
• Other Study ID Numbers: TTYY20140312

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No