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CompletedNCT02140658Updated Dec 11, 2018

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

An interventional study of multiple health education interventions and conventional health education in Ischemic Stroke, sponsored by yongjun wang. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-12-11.

Sponsored by yongjun wang · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
3,111
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Ischemic Stroke

Keywords

  • ischemic stroke
  • Statins Medication Persistence
  • outcome
03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,013 are open to participants now.

This study's enrollment of 3,111 is above the median of 50 across 5,366 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

yongjun wang is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
3,111 participants (actual)

Study arms

  • 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

Interventions

  • Behavioralmultiple health education interventions
  • Behavioralconventional health education
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3 months after stroke onset

  2. 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.

    Time frame: 6 months after stroke onset

  3. 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.

    Time frame: 12 months after stroke onset

  4. 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.

    Time frame: 1 year after stroke onset

  5. 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.

    Time frame: 3 months after stroke onset

  6. 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.

    Time frame: 6 months after stroke onset

  7. 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.

    Time frame: 12 months after stroke onset

Secondary outcomes

  1. 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

    Time frame: 3 months after stroke onset

  2. 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

    Time frame: 6 months after stroke onset

  3. 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

    Time frame: 12 months after stroke onset

07

Study locations

1 site
  • Beijing Tian Tan Hospital, Capital Medical University
    Beijing, 100050, China
08

References and documents

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. PubMed 34813082 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 11, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02140658
Lead sponsor
yongjun wang
Collaborators
Ministry of Science and Technology of the People´s Republic of China
Responsible party
yongjun wang (Professor,Vice president of Beijing Tiantan Hospital, Ministry of Science and Technology of the People´s Republic of China) — Sponsor-investigator
First posted
May 16, 2014
Start date
May 2014
Primary completion
Jun 2015
Completion
Sep 2015
Last update
Dec 11, 2018

Study contacts

Yongjun Wang, MD
principal investigator · Beijing Tian Tan Hospital, Capital Medical University, Beijing, China

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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