NCT02140658

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,111

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

May 5, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 16, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

December 11, 2018

Status Verified

December 1, 2018

Enrollment Period

1.1 years

First QC Date

May 5, 2014

Last Update Submit

December 9, 2018

Conditions

Ischemic Stroke

Keywords

ischemic strokeStatins Medication Persistenceoutcome

Outcome Measures

Primary Outcomes (7)

  • 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 Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (2)

multiple health education interventions

ACTIVE COMPARATOR

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

conventional health education

PLACEBO COMPARATOR

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

Interventions

multiple health education interventionsBEHAVIORAL
multiple health education interventions
conventional health educationBEHAVIORAL
conventional health education

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Tian Tan Hospital, Capital Medical University

Beijing, 100050, China

Location

Related Publications (1)

  • 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.

    PMID: 34813082DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Yongjun Wang, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor,Vice president of Beijing Tiantan Hospital

Study Record Dates

First Submitted

May 5, 2014

First Posted

May 16, 2014

Study Start

May 1, 2014

Primary Completion

June 1, 2015

Study Completion

September 1, 2015

Last Updated

December 11, 2018

Record last verified: 2018-12

Locations

CN(1)