Clinical trial NCT02140658: Affect of Health Education on Statins Medication Persistence and ClinicaL Prognosis of Ischemic Stroke Patients (HELP)
Official title: Affect of Multiple Health Education Interventions on Statins Medication Persistence and ClinicaL Prognosis of Ischemic Stroke Patients (HELP): a Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischemic Stroke
Keywords: ischemic stroke
Statins Medication Persistence
outcome
Lead sponsor: Ministry of Science and Technology of the People´s Republic of China
Sponsor class: OTHER_GOV
Collaborators: name: Ministry of Science and Technology of the People´s Republic of China
First posted: 2014-05-16
Enrollment: 3111
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients who continued taking statins drugs at three months after stroke onset.
timeFrame: 3 months after stroke onset
measure: Proportion of patients who continued taking statins drugs at six months after stroke onset.
timeFrame: 6 months after stroke onset
measure: Proportion of patients who continued taking statins drugs at 12 months after stroke onset.
timeFrame: 12 months after stroke onset
measure: Proportion of patients who continued taking statins drugs in 1 year after stroke onset.
timeFrame: 1 year after stroke onset
measure: Recurrence of ischemic stroke in three months after stroke onset
timeFrame: 3 months after stroke onset
measure: Recurrence of ischemic stroke in six months after stroke onset
timeFrame: 6 months after stroke onset
measure: Recurrence of ischemic stroke in 12 months after stroke onset
timeFrame: 12 months after stroke onset
Secondary outcomes:
measure: 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
timeFrame: 3 months after stroke onset
measure: 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
timeFrame: 6 months after stroke onset
measure: 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
timeFrame: 12 months after stroke onset
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tian Tan Hospital, Capital Medical University
Study officials:
affiliation: Beijing Tian Tan Hospital, Capital Medical University, Beijing, China
name: Yongjun Wang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.