An interventional study of Lecture-based learning (LBL) and PBL plus LBL in Medical Education, Endocrine System Diseases and Critical Illness, sponsored by Chaohu Hospital of Anhui Medical University. Completed at 1 site in China. Open to participants aged 22 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-03.
Sponsored by Chaohu Hospital of Anhui Medical University · Not applicable, Interventional, and Other
This randomized controlled trial evaluates whether an integrated online-offline multimodal teaching approach combining Problem-Based Learning (PBL), Case-Based Learning (CBL), and Case Three-Dimensional Teaching Method (CTTM) improves clinical self-efficacy and hands-on proficiency in managing endocrine and metabolic critical illness among internal medicine residents, compared to traditional lecture-based learning (LBL).
Ninety internal medicine residents on their first endocrine rotation will be randomly assigned in a 1:1:1 ratio to three groups: (1) Control group receiving traditional LBL alone; (2) Experimental group 1 receiving PBL plus LBL; (3) Experimental group 2 receiving the integrated PBL-CBL-CTTM closed-loop teaching program. All groups receive a standardized 12-hour curriculum on endocrine and metabolic critical illness, including diabetic ketoacidosis, hyperosmolar hyperglycemic syndrome, thyroid storm, and refractory hypoglycemia.
The primary outcome is the clinical skills assessment score (0-50 points). Secondary outcomes include theoretical examination scores, General Self-Efficacy Scale (GSES) scores, a self-developed Endocrine High-Risk Management Self-Efficacy Source Questionnaire (four dimensions based on Bandura's self-efficacy theory), teaching satisfaction, and semi-structured focus group interviews.
The study was conducted from September 2025 to August 2026 at the Fourth Affiliated Hospital of Anhui Medical University, Chaohu, China. This study aims to establish an evidence-based, replicable teaching model that addresses the gap between theoretical knowledge and clinical confidence in managing endocrine emergencies among residents.
322 studies on the registry are indexed under Endocrine System Diseases; 51 are open to participants now.
This study's enrollment of 90 is above the median of 69 across 221 interventional studies indexed under Endocrine System Diseases.
Browse Endocrine System Diseases studies →Chaohu Hospital of Anhui Medical University is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Received only in-person one-way didactic lectures (lecture-based learning, LBL) with self-directed review after class. No online discussions, ward-based training, CTTM resources, or post-class debriefing. Total 12-hour standardized curriculum on endocrine and metabolic critical illness. n=30.
Behavioral: Lecture-based learning (LBL)
Received pre-class online problem-based learning (PBL) via DingTalk (open-ended critical case questions, independent literature search, online group discussion) plus standardized in-person lectures (LBL), with self-directed review after class. No ward-based CTTM training or post-class debriefing. Total 12-hour standardized curriculum. n=30.
Behavioral: PBL plus LBL
Received integrated closed-loop teaching: pre-class PBL (identical to experimental group 1) plus standardized in-person lectures plus post-class ward-based case-based learning (CBL) with attending-supervised hands-on critical case training, case three-dimensional teaching method (CTTM) resources, and post-class debriefing. Total 12-hour standardized curriculum. n=30.
Behavioral: Integrated PBL-CBL-CTTM
In-person one-way didactic lectures with self-directed review after class. Total 12-hour standardized curriculum on endocrine and metabolic critical illness, including diabetic ketoacidosis, hyperosmolar hyperglycemic syndrome, thyroid storm, and refractory hypoglycemia.
Pre-class online problem-based learning (PBL) via DingTalk (open-ended critical case questions, independent literature search, online group discussion) plus standardized in-person lectures (LBL), with self-directed review after class. Total 12-hour standardized curriculum.
Integrated closed-loop teaching: pre-class online PBL (identical to experimental group 1) plus standardized in-person lectures plus post-class ward-based case-based learning (CBL) with attending-supervised hands-on critical case training, case three-dimensional teaching method (CTTM) resources, and post-class debriefing. Total 12-hour standardized curriculum.
Clinical skills assessment score
Assessed by group-blinded evaluators using a standardized clinical skills checklist immediately after the 12-hour intervention. Total score range: 0-50 points. Higher scores indicate better clinical proficiency in managing endocrine and metabolic critical illness.
Time frame: Immediately post-intervention (upon completion of the 12-hour curriculum)
Theoretical examination score
Closed-book written examination graded by blinded faculty. Total score range: 0-50 points, covering endocrine and metabolic critical illness knowledge.
Time frame: Immediately post-intervention
General Self-Efficacy Scale (GSES) score
10-item standardized self-efficacy scale (Cronbach's α=0.89), completed anonymously. Higher scores indicate greater general self-efficacy.
Time frame: Baseline (pre-intervention) and immediately post-intervention
Endocrine High-Risk Management Self-Efficacy Source Questionnaire score
Self-developed 4-dimension questionnaire based on Bandura's self-efficacy theory (mastery experience, vicarious learning, verbal persuasion, positive affect; Cronbach's α=0.81, CVI=0.92), completed anonymously.
Time frame: Baseline (pre-intervention) and immediately post-intervention
Teaching satisfaction scale score
5-dimension teaching satisfaction scale (recognition rate and mean score), completed anonymously.
Time frame: Immediately post-intervention
Focus group interview themes
Semi-structured focus group interviews (30-40 minutes each) with 24 residents selected via stratified purposive sampling, analyzed using Braun \& Clarke six-step thematic analysis method. Explores residents' experiences and psychological mechanisms underlying changes in clinical self-efficacy.
Time frame: Within 1 week post-intervention
Plan to share: No — This is a medical education randomized controlled trial. All data were collected through anonymous questionnaires and blinded assessments, and all participant identifiers were removed at the time of data collection. No individual participant-level clinical data exist that could be shared. Aggregated study data are presented in the published manuscript.
No publications or documents are linked to this record.
Ran from Sep 2025 to primary completion in Aug 2026, 11 months.
Of 45 non-industry interventional studies with no phase under Endocrine System Diseases, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 39. This study's 11 months is below that.
Counting every sponsor, half of 52 studies reached it within 23 months; a quarter within 11 and three quarters within 35.
Endocrine System Diseases covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
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This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Chaohu Hospital of Anhui Medical University