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

Primary Purpose

Ischemic Stroke

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
multiple health education interventions
conventional health education
Sponsored by
yongjun wang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Ischemic Stroke focused on measuring ischemic stroke, Statins Medication Persistence, outcome

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beijing Tian Tan Hospital, Capital Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

multiple health education interventions

conventional health education

Arm Description

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.

The second group will receive conventional health education during hospitalization except health education manuals, regular health education messages and Digital Video Disc (DVD)

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

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
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
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

Full Information

First Posted
May 5, 2014
Last Updated
December 9, 2018
Sponsor
yongjun wang
Collaborators
Ministry of Science and Technology of the People´s Republic of China
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1. Study Identification

Unique Protocol Identification Number
NCT02140658
Brief Title
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

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
May 2014 (Actual)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
yongjun wang
Collaborators
Ministry of Science and Technology of the People´s Republic of China

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke
Keywords
ischemic stroke, Statins Medication Persistence, outcome

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3111 (Actual)

8. Arms, Groups, and Interventions

Arm Title
multiple health education interventions
Arm Type
Active Comparator
Arm Description
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.
Arm Title
conventional health education
Arm Type
Placebo Comparator
Arm Description
The second group will receive conventional health education during hospitalization except health education manuals, regular health education messages and Digital Video Disc (DVD)
Intervention Type
Behavioral
Intervention Name(s)
multiple health education interventions
Intervention Type
Behavioral
Intervention Name(s)
conventional health education
Primary Outcome Measure Information:
Title
Proportion of patients who continued taking statins drugs at three months after stroke onset.
Description
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
Title
Proportion of patients who continued taking statins drugs at six months after stroke onset.
Description
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
Title
Proportion of patients who continued taking statins drugs at 12 months after stroke onset.
Description
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
Title
Proportion of patients who continued taking statins drugs in 1 year after stroke onset.
Description
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
Title
Recurrence of ischemic stroke in three months after stroke onset
Description
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
Title
Recurrence of ischemic stroke in six months after stroke onset
Description
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
Title
Recurrence of ischemic stroke in 12 months after stroke onset
Description
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 Outcome Measure Information:
Title
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
Description
Death included Vascular death and non-vascular death; Severe disabilities was defined as modified Rankin Scale ≥4
Time Frame
3 months after stroke onset
Title
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
Description
Death included Vascular death and non-vascular death; Severe disabilities was defined as modified Rankin Scale ≥4
Time Frame
6 months after stroke onset
Title
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
Description
Death included Vascular death and non-vascular death; Severe disabilities was defined as modified Rankin Scale ≥4
Time Frame
12 months after stroke onset

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yongjun Wang, MD
Organizational Affiliation
Beijing Tian Tan Hospital, Capital Medical University, Beijing, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Tian Tan Hospital, Capital Medical University
City
Beijing
ZIP/Postal Code
100050
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
34813082
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.
Results Reference
derived

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

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