Mobile Terminal Based Management of Stroke Secondary Prevention Adminstration Effect Research

November 27, 2015 updated by: Fan Dongsheng, Peking University Third Hospital

Mobile Terminal Based Management and Platelet Reactivity Modified Drug Regulation of Stroke Secondary Prevention

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100191
        • Peking University Third Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • stroke

Exclusion Criteria:

  • refusion in research

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change of the stroke recurrence rate
Time Frame: 2 years stroke recurrence rate
After secondary prevention
2 years stroke recurrence rate

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change of the stroke mortality
Time Frame: 2 years stroke mortality
After secondary prevention
2 years stroke mortality

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Third Hospital

Investigators

  • Study Director: Jie Qiao, PUTH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

September 16, 2015

First Submitted That Met QC Criteria

November 27, 2015

First Posted (Estimate)

December 1, 2015

Study Record Updates

Last Update Posted (Estimate)

December 1, 2015

Last Update Submitted That Met QC Criteria

November 27, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PUTH2013144

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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