NCT06941753

Brief Summary

This study is a single-center, randomized, open-label, controlled, endpoint-blinded study to assess the effect of off-script diagnosis \& differential diagnosis (D\&D) training in improving the residents' knowledge of acute ischemic stroke in China. The investigators will enroll 22 residents and assess the score of mASMaQ 30 days after randomization.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
16mo left

Started Jun 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress40%
Jun 2025Aug 2027

First Submitted

Initial submission to the registry

April 15, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 24, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

June 20, 2025

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2027

Last Updated

June 26, 2025

Status Verified

April 1, 2025

Enrollment Period

2.1 years

First QC Date

April 15, 2025

Last Update Submit

June 23, 2025

Conditions

Keywords

residentstroke education

Outcome Measures

Primary Outcomes (1)

  • mASMaQ

    Modified Acute Stroke Management Questionnaire (mASMaQ), with a range of 33-165 scores. Higher scores indicate superior acute ischemic stroke management knowledge. Blinded Assessment Protocol:1) Participant Requirements: Strict 10-minute time limit for independent completion; External references are prohibited; 2) Assessment Supervision: certified neurologists as proctors, who are blinded to group assignment throughout the trial. 3) Centralized Adjudication: based on participants' questionnaire responses. Note: Details of the modified ASMaQ has been on file with the ethics committee and cannot be changed. To prevent disclosure of the measures and bias in resident measurement, we do not disclose the scales until the trial is completed. Details of mASMaQ will be made public with the publication of the article.

    30 days

Secondary Outcomes (3)

  • General stroke knowledge

    30 days

  • Hyperacute stroke management

    30 days

  • Advanced stroke management

    30 days

Study Arms (2)

Off-script D&D training group

EXPERIMENTAL

Off-script D\&D training is required within 72 hours after randomization.

Other: Off-script diagnosis & differential diagnosis (D&D) training

No-Intervention Control Group

NO INTERVENTION

Off-script D\&D training is not required within 72 hours after randomization.

Interventions

1. Training Timeline: Must be completed within 72 hours post-randomization; Requires standardized structured off-script D\&D analysis. 2. Structured Analysis Framework: 1)Epidemiology: Incidence, mortality, and disability rates; 2) Etiologic Classification: TOAST classification system; 3) Vascular Mechanisms: Culprit vessel, vascular territory, pathophysiology; 4) Differential Diagnosis: Stroke mimics and stroke subtype differentiation; 5) Acute Management: Hyperacute interventions (thrombolysis/EVT), secondary prevention strategies, and evidence-based case analysis; 6) Patient Education: Stroke prevention education for patients/public; 7) Research Gaps: Current limitations and future directions. 3. Presentation Requirements: 1)Mandatory off-script delivery (no prepared text); 2) Time limit: 15+3 minutes for complete analysis.

Off-script D&D training group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Residents (physicians in postgraduate training).
  • Currently in neurology wards
  • Managing acute ischemic stroke (AIS) patients, defined as: 1)Time from onset to randomization ≤ 2 weeks; 2) If onset time is unknown, the last known well time is considered the onset time.
  • Signed informed consent

You may not qualify if:

  • Managing asymptomatic ischemic stroke patients.
  • Residents who are currently participating or have participated in another interventional ischemic stroke training program within the past 3 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

StrokeDisease Progression

Interventions

Fumigant 93

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jun Ni, MD

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2025

First Posted

April 24, 2025

Study Start

June 20, 2025

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

August 31, 2027

Last Updated

June 26, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations