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Completed

NCT Number: NCT02140658

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

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.

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Key information

Conditions

Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Tian Tan Hospital, Capital Medical University

Beijing, 100050, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

multiple health education interventions

Behavioral

Conventional health education

Behavioral

Primary outcomes

  1. Proportion of patients who continued taking statins drugs at three months after stroke onset.

    Time frame: 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.

  2. Proportion of patients who continued taking statins drugs at six months after stroke onset.

    Time frame: 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.

  3. Proportion of patients who continued taking statins drugs at 12 months after stroke onset.

    Time frame: 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.

  4. Proportion of patients who continued taking statins drugs in 1 year after stroke onset.

    Time frame: 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.

  5. Recurrence of ischemic stroke in three months after stroke onset

    Time frame: 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.

  6. Recurrence of ischemic stroke in six months after stroke onset

    Time frame: 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.

  7. Recurrence of ischemic stroke in 12 months after stroke onset

    Time frame: 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 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

    Time frame: 3 months after stroke onset

    Death included Vascular death and non-vascular death; Severe disabilities was defined as modified Rankin Scale ≥4

  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

    Time frame: 6 months after stroke onset

    Death included Vascular death and non-vascular death; Severe disabilities was defined as modified Rankin Scale ≥4

  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

    Time frame: 12 months after stroke onset

    Death included Vascular death and non-vascular death; Severe disabilities was defined as modified Rankin Scale ≥4

Sponsors and collaborators

Lead sponsor

yongjun wang

Other Gov

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
May 16, 2014
Registry last updated
Dec 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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