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Mobile Terminal Based Management of Stroke Secondary Prevention Adminstration Effect Research

NCT ID: NCT02618265

Last Updated: 2015-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2018-12-31

Brief Summary

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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

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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.

Conditions

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Stroke

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Mobile terminal

Intervention Type PROCEDURE

multiple strategy including mobile terminal based compliance managment, platelet reactivity modified drug adjustment

traditional management

Stroke received traditional management for secondary prevention administration

Group Type ACTIVE_COMPARATOR

traditional management

Intervention Type PROCEDURE

aspirin or clopidogrel monotherapy or double treatment for

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.

Group Type ACTIVE_COMPARATOR

website platform management

Intervention Type PROCEDURE

second prevention based on website platform management

Interventions

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Mobile terminal

multiple strategy including mobile terminal based compliance managment, platelet reactivity modified drug adjustment

Intervention Type PROCEDURE

traditional management

aspirin or clopidogrel monotherapy or double treatment for

Intervention Type PROCEDURE

website platform management

second prevention based on website platform management

Intervention Type PROCEDURE

Other Intervention Names

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Mobile Application traditional second prevention

Eligibility Criteria

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Inclusion Criteria

* stroke

Exclusion Criteria

* refusion in research
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University Third Hospital

OTHER

Sponsor Role lead

Responsible Party

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Fan Dongsheng

Chairman of Neurology Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jie Qiao

Role: STUDY_DIRECTOR

PUTH

Locations

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Peking University Third Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Central Contacts

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Dongsheng Fan

Role: CONTACT

[email protected]
+861082265032

Facility Contacts

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Dongsheng Fan

Role: primary

[email protected]
+861082265032

References

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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.

Reference Type DERIVED
PMID: 36163415 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32293574 (View on PubMed)

Other Identifiers

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PUTH2013144

Identifier Type: -

Identifier Source: org_study_id