Multilevel System Intervention Based on Information Platform to Reduce Ischemic Stroke Recurrence Rate

May 2, 2023 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

Multilevel System Intervention Based on Information Platform to Reduce Stroke Recurrence Rate in Acute Ischemic Stroke Patients

A prospective, multicenter and cluster randomised controlled trial will be conducted, using hospital as randomisation unit. Hospitals in Zhejiang Province, China, will be randomised into two arms (1:1): an intervention arm and a control arm. Hospitals in the intervention arm will receive a multilevel system intervention based on information platform, whereas hospitals in the control arm will receive no intervention. The randomisation will be conducted after baseline data collection. The following baseline data will be used for randomisation match: hospital classification, beds in stroke centre, and the number of acute ischemic stroke (AIS) patients within 7 days of stroke onset. Hospitals with <250 AIS cases per year will be excluded from the study. The primary outcome will be difference between intervention arm and control arm in the one-year stroke recurrence rate on the follow-up stage (post-intervention).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients of 18 years or older.
  • Patients admitted with neurological deficit consistent with ischemic stroke within 7 days of of symptoms onset. (*Symptom onset is defined by the "last seen normal" principle)
  • Confirmation of new ischemic stroke by objective modality of CT scan and MRI (had relevant lesions on DWI).
  • Informed consent from patient or legally authorised representative (primarily spouse, parents, adult children, otherwise indicated).

Exclusion Criteria:

  • Patients refuse to participate in this study.
  • Patients who losing his medical record of having the incomplete medical record

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: intervention arm
Hospitals in the intervention arm will receive a multilevel system intervention based on information platform
Behavioral: multilevel system intervention based on information platform
  1. Standardized templates of medical record
  2. Continuous medical quality control and feedback system: the hospital included in the study upload the medical records of all AIS patients by medical records scanning system. Quality control platform of Cerebral apoplexy in Zhejiang province extracts and analyze the data through the computer and calculates the percentage of stroke of undetermined cause.
  3. Team collaboration based on video conferencing: hospitals will receive corresponding suggestions for their improvement from experts online.
  4. Enhanced feedback incentives
No Intervention: control arm
Hospitals in the control arm will receive no intervention

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence rate of new ischemic stroke events
Time Frame: 1 year
To evaluate the efficacy of intervention in reducing the risk of new ischemic stroke events at 1 year after initial symptom onset.
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence rate of new ischemic stroke events
Time Frame: 3, 5 years
Incidence rate of new ischemic stroke events at 3, 5 years after initial symptom onset.
3, 5 years
Incidence rate of new clinical vascular events (ischemic stroke, hemorrhagic stroke, myocardial infarction)
Time Frame: 1, 3, 5 years
incidence rate of new clinical vascular events (ischemic stroke, hemorrhagic stroke, myocardial infarction) at 1, 3, 5 years after initial symptom onset.
1, 3, 5 years
All-cause mortality
Time Frame: 1, 3, 5 years
All-cause mortality
1, 3, 5 years
The percentage of stroke of undetermined cause at discharge
Time Frame: 1 year
The percentage of stroke of undetermined cause at discharge
1 year
Rate of antithrombotic therapy at discharge
Time Frame: 1 year
The rate of patients with cerebral infarction who received antithrombotic drugs (such as aspirin, other antiplatelet agents, heparin, warfarin or new oral anticoagulants) at discharge in the total number of hospitalized patients with cerebral infarction in the same period.
1 year
Rate of anticoagulant treatment for patients with atrial fibrillation at discharge
Time Frame: 1 year
The rate of patients with cerebral infarction complicated with atrial fibrillation who received anticoagulants (e.g., heparin, low molecular heparin, warfarin, new oral anticoagulants) at discharge in the total number of patients with cerebral infarction complicated with atrial fibrillation treated in hospital in the same period
1 year
Rate of blood vessel assessment within one week of hospitalization
Time Frame: 1 year
The rate of patients with cerebral infarction hospitalized for 1 week who had completed the evaluation of the blood vessels in the neck and cranial (such as the ultrasound of the blood vessels in the neck or cranial, CT or MR angiography, or DSA) in the total number of cerebral infarction patients hospitalized in the same period
1 year

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Zexin Chen, Tthe second affiliated hospital, school of medicine, Zhejiang University, China

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 (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2023

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2025

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 2, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 10, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 10, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MISA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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