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临床试验/NCT07755878
NCT07755878进行中(未招募)不适用

Supervised Hospital-Based Practice Versus Matched Online Activities in Cardiac Rehabilitation Training for Cardiology Residents: A Randomized Controlled Trial

Second Affiliated Hospital, Zhejiang University, School of Medicine1 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2025年3月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
98
试验地点
1
主要终点
Post-training cardiac rehabilitation knowledge score adjusted for baseline

研究概览

简要总结

This randomized controlled trial compares supervised hospital-based practice with matched online activities as part of a common cardiac rehabilitation curriculum for cardiology residents. Ninety-eight residents will be allocated 1:1 to a blended group or an online control group. Both groups will receive the same seven-module online curriculum and the same total scheduled learning time. The blended group will complete a matched block of in-person practice in the cardiology ward, outpatient clinic, and cardiopulmonary exercise testing laboratory, whereas the control group will complete matched-duration supplementary online activities. The primary outcome is the post-training 25-item cardiac rehabilitation knowledge score adjusted for the baseline score. Key secondary outcomes are Mini-CEX and procedure-specific DOPS scores assessed by assessors blinded to allocation.

详细描述

The curriculum covers cardiac rehabilitation principles; phase I and phase II rehabilitation; cardiopulmonary exercise testing (CPET) and report interpretation; individualized exercise prescription; medication, exercise, nutrition, psychological care, and smoking-cessation prescriptions; multidisciplinary management; patient communication; and management of exercise-related acute events.

Both groups receive the same online course, syllabus, learning objectives, and approximately 12 hours of scheduled learning. The blended group replaces one matched-duration block of supplementary online learning with seven supervised in-person sessions. These sessions involve teaching with real patients who provide separate agreement, standardized cases, CPET reports, simulated acute-event scenarios, and immediate feedback. The control group completes additional online case discussions and structured self-study assignments covering the same modules.

Measurements occur at three ordered time points. Before randomization and course access, participants complete baseline information and the fixed 25-item knowledge pretest. Immediately after completion of the 7-week course and before release of assessment results, participants complete the same 25-item knowledge post-test and a separate anonymous learner-reported form. Within 7 days after course completion, two independent assessors blinded to allocation complete the Mini-CEX and DOPS ratings. The primary analysis follows the intention-to-treat principle and uses ANCOVA of the post-training knowledge score adjusted for the baseline knowledge score, with multiple imputation for missing baseline or post-training knowledge outcomes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

盲法说明

Residents and instructors cannot be blinded to the educational delivery mode. The two Mini-CEX and DOPS examiners do not participate in teaching and are blinded to group allocation.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Resident physician currently participating in standardized residency training
  • •Undertaking a rotation in the Department of Cardiology
  • •Available to attend the cardiac rehabilitation course and study assessments
  • •Provides written informed consent

排除标准

  • •Prior systematic cardiac rehabilitation training
  • •Extensive clinical experience in a dedicated cardiac rehabilitation program
  • •Unable to attend the course at the time eligibility is assessed
  • •Declines participation

研究组 & 干预措施

Online control group

Active Comparator

Participants complete the common seven-module online cardiac rehabilitation course and matched-duration supplementary online case discussions and structured self-study assignments.

干预措施: Common online cardiac rehabilitation curriculum (Other)

Online control group

Active Comparator

Participants complete the common seven-module online cardiac rehabilitation course and matched-duration supplementary online case discussions and structured self-study assignments.

干预措施: Matched supplementary online learning (Other)

Blended learning group

Experimental

Participants complete the common seven-module online cardiac rehabilitation course and replace the matched supplementary online block with seven supervised, hospital-based case and practice sessions.

干预措施: Common online cardiac rehabilitation curriculum (Other)

Blended learning group

Experimental

Participants complete the common seven-module online cardiac rehabilitation course and replace the matched supplementary online block with seven supervised, hospital-based case and practice sessions.

干预措施: Hospital-based case and practice sessions (Other)

结局指标

主要结局

Post-training cardiac rehabilitation knowledge score adjusted for baseline

时间窗: Immediately after completion of the 7-week course

A fixed 25-item multiple-choice examination assesses cardiac rehabilitation fundamentals, phase I rehabilitation, phase II rehabilitation, CPET, exercise prescription, and case-based application. Each correct answer is worth 4 points; total scores range from 0 to 100, with higher scores indicating greater knowledge. The primary estimand is the adjusted between-group difference in the post-training total score from ANCOVA with the baseline total score as a covariate.

次要结局

  • Mini-Clinical Evaluation Exercise total score(Within 7 days after completion of the 7-week course)
  • Procedure-specific Direct Observation of Procedural Skills total score(Within 7 days after completion of the 7-week course)

研究者

发起方
Second Affiliated Hospital, Zhejiang University, School of Medicine
申办方类型
Other
责任方
Sponsor

研究点 (1)

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