- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06613074
Ali Pay Intelligent Navigation Applet-aided Pre-hospital Triage for Non-emergency Medical Service Patients With Acute Ischemic Stroke (i-Path)
Ali Pay Intelligent Navigation Applet-aided Pre-hospital Triage for Non-emergency Medical Service Patients With Acute Ischemic Stroke: A Step-wedge Cluster Randomized Controlled Trial
According to the Bigdata Observatory platform for Stroke of China (BOSC), the proportion of patients with acute ischemic stroke (AIS) receiving intravenous thrombolysis or endovascular treatment in China is 5.64% and 1.45% respectively. One of the important reasons for the low treatment rate is the prolonged pre-hospital and in-hospital delay. Besides, for patients receiving reperfusion therapy, the prolonged pre-treatment delay is associated with unfavorable functional outcomes.
Although tons of efforts have been made to improve the efficiency of emergency medical system in the transportation of patients with AIS, little attention has been paid to patients who arrived at hospitals on their owns, which occupying approximately 2/3 of emergency patients. This leaves a huge gap in the pre-hospital management of patietns with AIS.
Therefore, the investigators plan to develop an intelligent navigation system for patients with AIS. For the convenience of public use, this system was carried on the applet of Ali Pay, which has over 1.1 billion users in China. This system comprises of three functional modules, namely stroke knowledge education, stroke recognition and hospital recommendation. The investigators aim to explore whether this intelligent navigatino system could shorten pre-hospital delay and improve functional outcomes of patients with AIS undergoing reperfusion therapy.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
According to the Bigdata Observatory platform for Stroke of China (BOSC), the proportion of patients with acute ischemic stroke (AIS) receiving intravenous thrombolysis or endovascular treatment in China is 5.64% and 1.45% respectively. One of the important reasons for the low treatment rate is the prolonged pre-hospital and in-hospital delay. Besides, for patients receiving reperfusion therapy, the prolonged pre-treatment delay is associated with unfavorable functional outcomes.
Although tons of efforts have been made to improve the efficiency of emergency medical system in the transportation of patients with AIS, little attention has been paid to patients who arrived at hospitals on their owns, which occupying approximately 2/3 of emergency patients. This leaves a huge gap in the pre-hospital management of patietns with AIS.
Therefore, the investigators plan to develop an intelligent navigation system for patients with AIS. For the convenience of public use, this system was carried on the applet of Ali Pay, which has over 1.1 billion users in China. This system comprises of three functional modules, namely stroke knowledge education, stroke recognition and hospital recommendation.The investigators aim to explore whether this intelligent navigatino system could shorten pre-hospital delay and improve functional outcomes of patients with AIS undergoing reperfusion therapy.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Min Lou, PhD, MD
- Phone Number: 86057187783777
- Email: lm99@zju.edu.cn
Study Locations
-
-
Zhejing
-
Shaoxing, Zhejing, China, 312000
- Recruiting
- Shaoxing people's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients diagnosed as acute ischemic stroke undergoing reperfusion therapy within 24 hours of onset
Exclusion Criteria:
- Patients transported to hospitals via emergency medical service
- Patients with in-hospital stroke
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Ali Pay intelligent navigation applet group
Patients in regions with Ali Pay intelligent navigation applet being released would be classified as experimental arm. In this arm, patients have access to this applet. The intelligent navigation applet comprises of three function modules:
|
The intelligent navigation applet comprises of three function modules:
|
|
No Intervention: Routine pre-hospital triage
Patients in regions without Ali Pay intelligent navigation applet being released would be classified as control arm. In this arm, patients do not have access to this applet. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Modified rankin scale (mRS) scores of 0-2 at 90 days after reperfusion therapy
Time Frame: 90 days
|
90 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Modified rankin scale (mRS) scores of 0-1 at 90 days after reperfusion therapy
Time Frame: 90 days
|
90 days
|
|
|
Modified rankin scale (mRS) scores of 0-3 at 90 days after reperfusion therapy
Time Frame: 90 days
|
90 days
|
|
|
Ordinal analysis of modified rankin scale (mRS) scores at 90 days after reperfusion therapy
Time Frame: 90 days
|
90 days
|
|
|
Time interval between onset to treatment
Time Frame: 1 day
|
1 day
|
|
|
Time interval between onset to hospital
Time Frame: 1 day
|
1 day
|
|
|
Proportion of patients receiving reperfusion beyond time window
Time Frame: 1 day
|
Intravenous thrombolysis: treatment initiated within 4.5 - 9 hours after onset Mechanical thrombectomy: treatment initiated within 6 - 24 hours after onset
|
1 day
|
|
Proportion of patients receiving mechanical thrombectomy
Time Frame: 1 day
|
1 day
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- i-Path
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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