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Mobile Terminal Based Management of Stroke Secondary Prevention Adminstration Effect Research

Sponsor
Peking University Third Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02618265
Collaborator
(none)
400
Enrollment
1
Location
3
Arms
35
Duration (Months)
11.4
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Mobile terminal
  • Procedure: traditional management
  • Procedure: website platform management
 N/A

Detailed Description

With high incidence, mortality, morbidity and recurrence rateļ¼Œstroke 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
400 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Mobile Terminal Based Management and Platelet Reactivity Modified Drug Regulation of Stroke Secondary Prevention
Study Start Date :
Jan 1, 2016
Anticipated Primary Completion Date :
Dec 1, 2016
Anticipated Study Completion Date :
Dec 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Mobile terminal

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.

Procedure: Mobile terminal
multiple strategy including mobile terminal based compliance managment, platelet reactivity modified drug adjustment
Other Names:
  • Mobile Application

    		•
    Active Comparator: traditional management

    Stroke received traditional management for secondary prevention administration

    Procedure: traditional management
    aspirin or clopidogrel monotherapy or double treatment for
    Other Names:
  • traditional second prevention

    		•
    Active Comparator: website platform management

    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.

    Procedure: website platform management
    second prevention based on website platform management

    Outcome Measures

    Primary Outcome Measures

    1. change of the stroke recurrence rate [2 years stroke recurrence rate]

      After secondary prevention

    Secondary Outcome Measures

    1. change of the stroke mortality [2 years stroke mortality]

      After secondary prevention

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • stroke
    Exclusion Criteria:
    • refusion in research

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Peking University Third Hospital Beijing Beijing China 100191

    Sponsors and Collaborators

    • Peking University Third Hospital

    Investigators

    • Study Director: Jie Qiao, PUTH

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fan Dongsheng, Chairman of Neurology Department, Peking University Third Hospital
    ClinicalTrials.gov Identifier:
    NCT02618265
    Other Study ID Numbers:
    • PUTH2013144
    First Posted:
    Dec 1, 2015
    Last Update Posted:
    Dec 1, 2015
    Last Verified:
    Nov 1, 2015
    Keywords provided by Fan Dongsheng, Chairman of Neurology Department, Peking University Third Hospital
    stroke
    secondary prevention
    platelet response polymorphism
    mobile terminal
    Additional relevant MeSH terms:
    Stroke

    Study Results

    No Results Posted as of Dec 1, 2015