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

NCT ID: NCT02140658

Last Updated: 2018-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

3111 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2015-09-30

Brief Summary

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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

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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.

Conditions

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Ischemic Stroke

Keywords

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ischemic stroke Statins Medication Persistence outcome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

multiple health education interventions

Intervention Type BEHAVIORAL

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)

Group Type PLACEBO_COMPARATOR

conventional health education

Intervention Type BEHAVIORAL

Interventions

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multiple health education interventions

Intervention Type BEHAVIORAL

conventional health education

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Science and Technology of the People´s Republic of China

OTHER_GOV

Sponsor Role collaborator

yongjun wang

OTHER_GOV

Sponsor Role lead

Responsible Party

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yongjun wang

Professor,Vice president of Beijing Tiantan Hospital

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Yongjun Wang, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Beijing Tian Tan Hospital, Capital Medical University

Beijing, , China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 34813082 (View on PubMed)

Other Identifiers

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TTYY20140312

Identifier Type: -

Identifier Source: org_study_id