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Affect of Multiple Health Education on Medication Persistence and Clinical Prognosis of Ischemic Stroke Patients

Primary Purpose

Ischemic Stroke, Medication Persistence

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
multiple health education interventions
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, 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. Patients signed informed consent
  4. 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. Those who are participating in other clinical trials
  6. Those who can not guarantee with the completion of 1 year 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 group will receive health education manuals and Digital Video Disc (DVD) during hospitalization and regular text message during 1 year after discharge.

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

Outcomes

Primary Outcome Measures

Proportion of patients who continued taking antiplatelet drugs at three months after stroke onset, and proportion of patients who continued taking statins drugs at three months after stroke onset.
Medication persistence at 3 months. Persistence is defined as continuing a therapy or class of therapy from discharge to the 3 months follow-up. Subjects prescribed an individual medication at discharge but who were not taking that medication at follow up were defined as "nonpersistent". Persistence for the specified medication classes (antiplatelet, statins) was defined in the same way; however, subjects were considered persistent if there was a switch to another medication within the same class.
Proportion of patients who continued taking antiplatelet drugs at six months after stroke onset, and proportion of patients who continued taking statins drugs at six months after stroke onset.
Medication persistence at 6 months. Persistence at 6 months is defined as continuing a therapy or class of therapy at 6 months follow-up. Subjects prescribed an individual medication at discharge but who were not taking that medication at follow up were defined as "nonpersistent". Persistence for the specified medication classes (antiplatelet, statins) was defined in the same way; however, subjects were considered persistent if there was a switch to another medication within the same class.
Proportion of patients who continued taking antiplatelet drugs at 12 months after stroke onset, and proportion of patients who continued taking statins drugs at 12 months after stroke onset.
Medication persistence at 12 months. Persistence at 12 months is defined as continuing a therapy or class of therapy at 12 months follow-up. Subjects prescribed an individual medication at discharge but who were not taking that medication at follow up were defined as "nonpersistent". Persistence for the specified medication classes (antiplatelet, statins) was defined in the same way; however, subjects were considered persistent if there was a switch to another medication within the same class.
Proportion of patients who continued taking antiplatelet drugs in 1 year after stroke onset, and proportion of patients who continued taking statins drugs in 1 year after stroke onset.
Patients who took statins and antiplatelet medications 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 IS 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 IS 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 IS 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

clinical prognosis
Death(including Vascular death and non-vascular death); Nonfatal myocardial infarction; Nonfatal hemorrhagic stroke; Severe disabilities(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
NCT02140619
Brief Title
Affect of Multiple Health Education on Medication Persistence and Clinical Prognosis of Ischemic Stroke Patients
Official Title
Affect of Multiple Health Education Interventions on Secondary Prevention Medication Persistence and Clinical Prognosis of Ischemic Stroke Patients: 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 28, 2015 (Actual)
Study Completion Date
September 30, 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 study aimed to demonstrate the relationship between secondary prevention medication persistence and clinical prognosis of ischemic stroke patients at 3,6,12 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 antiplatelet and statins medication within 1 year, and the main purpose was to explore the impact of persistent statins and antiplatelet medication 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, Medication Persistence
Keywords
ischemic stroke, 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 group will receive health education manuals and Digital Video Disc (DVD) during hospitalization and regular text message during 1 year 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, text message and Digital Video Disc (DVD)
Intervention Type
Behavioral
Intervention Name(s)
multiple health education interventions
Primary Outcome Measure Information:
Title
Proportion of patients who continued taking antiplatelet drugs at three months after stroke onset, and proportion of patients who continued taking statins drugs at three months after stroke onset.
Description
Medication persistence at 3 months. Persistence is defined as continuing a therapy or class of therapy from discharge to the 3 months follow-up. Subjects prescribed an individual medication at discharge but who were not taking that medication at follow up were defined as "nonpersistent". Persistence for the specified medication classes (antiplatelet, statins) was defined in the same way; however, subjects were considered persistent if there was a switch to another medication within the same class.
Time Frame
3 months after stroke onset
Title
Proportion of patients who continued taking antiplatelet drugs at six months after stroke onset, and proportion of patients who continued taking statins drugs at six months after stroke onset.
Description
Medication persistence at 6 months. Persistence at 6 months is defined as continuing a therapy or class of therapy at 6 months follow-up. Subjects prescribed an individual medication at discharge but who were not taking that medication at follow up were defined as "nonpersistent". Persistence for the specified medication classes (antiplatelet, statins) was defined in the same way; however, subjects were considered persistent if there was a switch to another medication within the same class.
Time Frame
6 months after stroke onset
Title
Proportion of patients who continued taking antiplatelet drugs at 12 months after stroke onset, and proportion of patients who continued taking statins drugs at 12 months after stroke onset.
Description
Medication persistence at 12 months. Persistence at 12 months is defined as continuing a therapy or class of therapy at 12 months follow-up. Subjects prescribed an individual medication at discharge but who were not taking that medication at follow up were defined as "nonpersistent". Persistence for the specified medication classes (antiplatelet, statins) was defined in the same way; however, subjects were considered persistent if there was a switch to another medication within the same class.
Time Frame
12 months after stroke onset
Title
Proportion of patients who continued taking antiplatelet drugs in 1 year after stroke onset, and proportion of patients who continued taking statins drugs in 1 year after stroke onset.
Description
Patients who took statins and antiplatelet medications 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 IS 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 IS 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 IS 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
clinical prognosis
Description
Death(including Vascular death and non-vascular death); Nonfatal myocardial infarction; Nonfatal hemorrhagic stroke; Severe disabilities(modified Rankin Scale≥4)
Time Frame
3,6,12 months

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 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 Those who are participating in other clinical trials Those who can not guarantee with the completion of 1 year 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
State/Province
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 Multiple Health Education on Medication Persistence and Clinical Prognosis of Ischemic Stroke Patients

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