Nctid:
NCT06613074
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000020521", "term"=>"Stroke"}, {"id"=>"D000083242", "term"=>"Ischemic Stroke"}, {"id"=>"D000002544", "term"=>"Cerebral Infarction"}, {"id"=>"D000007511", "term"=>"Ischemia"}], "ancestors"=>[{"id"=>"D000002561", "term"=>"Cerebrovascular Disorders"}, {"id"=>"D000001927", "term"=>"Brain Diseases"}, {"id"=>"D000002493", "term"=>"Central Nervous System Diseases"}, {"id"=>"D000009422", "term"=>"Nervous System Diseases"}, {"id"=>"D000014652", "term"=>"Vascular Diseases"}, {"id"=>"D000002318", "term"=>"Cardiovascular Diseases"}, {"id"=>"D000010335", "term"=>"Pathologic Processes"}, {"id"=>"D000020520", "term"=>"Brain Infarction"}, {"id"=>"D000002545", "term"=>"Brain Ischemia"}, {"id"=>"D000007238", "term"=>"Infarction"}, {"id"=>"D000009336", "term"=>"Necrosis"}], "browseLeaves"=>[{"id"=>"M22306", "name"=>"Stroke", "asFound"=>"Stroke", "relevance"=>"HIGH"}, {"id"=>"M10543", "name"=>"Ischemia", "asFound"=>"Ischemic", "relevance"=>"HIGH"}, {"id"=>"M2400", "name"=>"Ischemic Stroke", "asFound"=>"Ischemic Stroke", "relevance"=>"HIGH"}, {"id"=>"M10282", "name"=>"Infarction", "relevance"=>"LOW"}, {"id"=>"M5793", "name"=>"Cerebral Infarction", "asFound"=>"Ischemic Stroke", "relevance"=>"HIGH"}, {"id"=>"M5810", "name"=>"Cerebrovascular Disorders", "relevance"=>"LOW"}, {"id"=>"M5204", "name"=>"Brain Diseases", "relevance"=>"LOW"}, {"id"=>"M5742", "name"=>"Central Nervous System Diseases", "relevance"=>"LOW"}, {"id"=>"M17400", "name"=>"Vascular Diseases", "relevance"=>"LOW"}, {"id"=>"M22305", "name"=>"Brain Infarction", "relevance"=>"LOW"}, {"id"=>"M5794", "name"=>"Brain Ischemia", "relevance"=>"LOW"}, {"id"=>"M12284", "name"=>"Necrosis", "relevance"=>"LOW"}, {"id"=>"T170", "name"=>"Acute Graft Versus Host Disease", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}, {"name"=>"Heart and Blood Diseases", "abbrev"=>"BC14"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"SINGLE", "whoMasked"=>["OUTCOMES_ASSESSOR"]}, "primaryPurpose"=>"HEALTH_SERVICES_RESEARCH", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>20000}}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-10-01", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2026-05-01", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-30", "studyFirstSubmitDate"=>"2024-09-23", "studyFirstSubmitQcDate"=>"2024-09-23", "lastUpdatePostDateStruct"=>{"date"=>"2024-10-02", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-25", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2026-05-01", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Modified rankin scale (mRS) scores of 0-2 at 90 days after reperfusion therapy", "timeFrame"=>"90 days"}], "secondaryOutcomes"=>[{"measure"=>"Modified rankin scale (mRS) scores of 0-1 at 90 days after reperfusion therapy", "timeFrame"=>"90 days"}, {"measure"=>"Modified rankin scale (mRS) scores of 0-3 at 90 days after reperfusion therapy", "timeFrame"=>"90 days"}, {"measure"=>"Ordinal analysis of modified rankin scale (mRS) scores at 90 days after reperfusion therapy", "timeFrame"=>"90 days"}, {"measure"=>"Time interval between onset to treatment", "timeFrame"=>"1 day"}, {"measure"=>"Time interval between onset to hospital", "timeFrame"=>"1 day"}, {"measure"=>"Proportion of patients receiving reperfusion beyond time window", "timeFrame"=>"1 day", "description"=>"Intravenous thrombolysis: treatment initiated within 4.5 - 9 hours after onset Mechanical thrombectomy: treatment initiated within 6 - 24 hours after onset"}, {"measure"=>"Proportion of patients receiving mechanical thrombectomy", "timeFrame"=>"1 day"}]}, "oversightModule"=>{"isUsExport"=>false, "oversightHasDmc"=>true, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["reperfusion therapy", "pre-hospital triage"], "conditions"=>["Acute Ischemic Stroke"]}, "descriptionModule"=>{"briefSummary"=>"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.\n\nAlthough 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.\n\nTherefore, 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.", "detailedDescription"=>"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.\n\nAlthough 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.\n\nTherefore, 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."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Patients diagnosed as acute ischemic stroke undergoing reperfusion therapy within 24 hours of onset\n\nExclusion Criteria:\n\n* Patients transported to hospitals via emergency medical service\n* Patients with in-hospital stroke"}, "identificationModule"=>{"nctId"=>"NCT06613074", "acronym"=>"i-Path", "briefTitle"=>"Ali Pay Intelligent Navigation Applet-aided Pre-hospital Triage for Non-emergency Medical Service Patients with Acute Ischemic Stroke", "organization"=>{"class"=>"OTHER", "fullName"=>"Second Affiliated Hospital, School of Medicine, Zhejiang University"}, "officialTitle"=>"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", "orgStudyIdInfo"=>{"id"=>"i-Path"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Ali Pay intelligent navigation applet group", "description"=>"Patients in regions with Ali Pay intelligent navigation applet being released would be classified as experimental arm.\n\nIn this arm, patients have access to this applet.\n\nThe intelligent navigation applet comprises of three function modules:\n\n1. Stroke knowledge public education: information regarding prevention and emergency treatment of stroke would be push to users' mobile phones regularly;\n2. Stroke recognition: questionaires, voice interaction, and facial recognition are employed to identify patients with AIS and large vessel occlusion;\n3. Hospital recommendation: this module combines real-time traffic and average in-hopital delay of each stroke center nearby, recommending the stroke center in which patients are mostly likely to receive reperfusion therapy", "interventionNames"=>["Device: Ali Pay intelligent navigation applet"]}, {"type"=>"NO_INTERVENTION", "label"=>"Routine pre-hospital triage", "description"=>"Patients in regions without Ali Pay intelligent navigation applet being released would be classified as control arm.\n\nIn this arm, patients do not have access to this applet."}], "interventions"=>[{"name"=>"Ali Pay intelligent navigation applet", "type"=>"DEVICE", "description"=>"The intelligent navigation applet comprises of three function modules:\n\n1. Stroke knowledge public education: information regarding prevention and emergency treatment of stroke would be push to users\\' mobile phones regularly;\n2. Stroke recognition: questionaires, voice interaction, and facial recognition are employed to identify patients with AIS and large vessel occlusion;\n3. Hospital recommendation: this module combines real-time traffic and average in-hopital delay of each stroke center nearby, recommending the stroke center in which patients are mostly likely to receive reperfusion therapy", "armGroupLabels"=>["Ali Pay intelligent navigation applet group"]}]}, "contactsLocationsModule"=>{"centralContacts"=>[{"name"=>"Min Lou, PhD, MD", "role"=>"CONTACT", "email"=>"lm99@zju.edu.cn", "phone"=>"86057187783777"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Second Affiliated Hospital, School of Medicine, Zhejiang University", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Prof. Dr.", "investigatorFullName"=>"Min Lou", "investigatorAffiliation"=>"Second Affiliated Hospital, School of Medicine, Zhejiang University"}}}}
