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Mobile Terminal Based Management of Stroke Secondary Prevention Adminstration Effect Research

Primary Purpose

Stroke

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Mobile terminal
traditional management
website platform management
Sponsored by
Peking University Third Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stroke focused on measuring stroke, secondary prevention, platelet response polymorphism, mobile terminal

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • stroke

Exclusion Criteria:

  • refusion in research

Sites / Locations

  • Peking University Third Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Mobile terminal

traditional management

website platform management

Arm Description

Stroke received mobile terminal management for secondary prevention administration, as the same time platelet reactivity modified drug selection was performed. Mobile application management conducts the control and regulation for anti hypertension, statin and antiplatelet therapy to increasing drug compliance.

Stroke received traditional management for secondary prevention administration

Stroke received website platform management for secondary prevention administration. Website platform management conducts the control and regulation for anti hypertension, statin and antiplatelet therapy to increasing drug compliance.

Outcomes

Primary Outcome Measures

change of the stroke recurrence rate
After secondary prevention

Secondary Outcome Measures

change of the stroke mortality
After secondary prevention

Full Information

First Posted
September 16, 2015
Last Updated
November 27, 2015
Sponsor
Peking University Third Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02618265
Brief Title
Mobile Terminal Based Management of Stroke Secondary Prevention Adminstration Effect Research
Official Title
Mobile Terminal Based Management and Platelet Reactivity Modified Drug Regulation of Stroke Secondary Prevention
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University Third Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The investigators want to verify whether mobile application based on stroke strengthen prevention management is more effective than traditional management model or open stroke management platform. Whole blood-impedance based platelet aggregation(WBA) method and VerifyNow detected by aspirin or clopidogrel responsiveness will provide individualized anti-platelet drug selection. Endpoint event is defined as stroke death or relapse. Primary measure outcomes are change of the stroke recurrence rate and mortality after secondary prevention.
Detailed Description
With high incidence, mortality, morbidity and recurrence rate,stroke has significant impact on national development strategies planning. Improving secondary prevention will strongly promote stroke management in the rapid developing phase of Chinese economy and expansion of health situation. At present lack of high-quality medical resources, low medical permeability cannot remedy extensive prevention failure of stroke. Mobile healthcare is easier to conduct and still in the early stage of explosive growth. This research group has established an open management platform of stroke prevention. And collaborate with Peking University Institute of Information Technology to develop a smart phone application which can be personalized medication reminder, record medication compliance, home blood pressure and blood glucose test results, also can provide doctor-patient communication platform and symptoms alarm. The investigators want to verify whether mobile application based on stroke strengthen prevention management is more effective than traditional management model or open stroke management platform. Whole blood-impedance based platelet aggregation(WBA) method and VerifyNow detected by aspirin or clopidogrel responsiveness will provide individualized anti-platelet drug selection. Control group will be selected from the National Stroke data registration database platform and open platform for stroke prevention. Follow-up period is 2 years. Endpoint event is defined as stroke death or relapse. Primary measure outcomes are change of the stroke recurrence rate and mortality after secondary prevention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke, secondary prevention, platelet response polymorphism, mobile terminal

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mobile terminal
Arm Type
Experimental
Arm Description
Stroke received mobile terminal management for secondary prevention administration, as the same time platelet reactivity modified drug selection was performed. Mobile application management conducts the control and regulation for anti hypertension, statin and antiplatelet therapy to increasing drug compliance.
Arm Title
traditional management
Arm Type
Active Comparator
Arm Description
Stroke received traditional management for secondary prevention administration
Arm Title
website platform management
Arm Type
Active Comparator
Arm Description
Stroke received website platform management for secondary prevention administration. Website platform management conducts the control and regulation for anti hypertension, statin and antiplatelet therapy to increasing drug compliance.
Intervention Type
Procedure
Intervention Name(s)
Mobile terminal
Other Intervention Name(s)
Mobile Application
Intervention Description
multiple strategy including mobile terminal based compliance managment, platelet reactivity modified drug adjustment
Intervention Type
Procedure
Intervention Name(s)
traditional management
Other Intervention Name(s)
traditional second prevention
Intervention Description
aspirin or clopidogrel monotherapy or double treatment for
Intervention Type
Procedure
Intervention Name(s)
website platform management
Intervention Description
second prevention based on website platform management
Primary Outcome Measure Information:
Title
change of the stroke recurrence rate
Description
After secondary prevention
Time Frame
2 years stroke recurrence rate
Secondary Outcome Measure Information:
Title
change of the stroke mortality
Description
After secondary prevention
Time Frame
2 years stroke mortality

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: stroke Exclusion Criteria: refusion in research
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dongsheng Fan
Phone
+861082265032
Email
dsfan@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jie Qiao
Organizational Affiliation
PUTH
Official's Role
Study Director
Facility Information:
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dongsheng Fan
Phone
+861082265032
Email
dsfan@sina.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
36163415
Citation
Zhang Y, Fan D, Qiao S, Hu H. Verifynow P2Y12 PRU-Guided Modification of Clopidogrel for Prevention of Recurrent Ischemic Stroke: A Real-World Prospective Cohort Study. Neurol Ther. 2022 Dec;11(4):1749-1766. doi: 10.1007/s40120-022-00406-z. Epub 2022 Sep 26.
Results Reference
derived
PubMed Identifier
32293574
Citation
Zhang Y, Fan D, Ji H, Qiao S, Li X. Treatment Adherence and Secondary Prevention of Ischemic Stroke Among Discharged Patients Using Mobile Phone- and WeChat-Based Improvement Services: Cohort Study. JMIR Mhealth Uhealth. 2020 Apr 15;8(4):e16496. doi: 10.2196/16496. Erratum In: JMIR Mhealth Uhealth. 2020 Apr 29;8(4):e19454.
Results Reference
derived

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Mobile Terminal Based Management of Stroke Secondary Prevention Adminstration Effect Research

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