Medical EducationPBL-CBL-CTTMNCT07801170
Integrated PBL-CBL-CTTM Teaching to Enhance Clinical Self-Efficacy in Endocrine Critical Illness Among Internal Medicine Residents: An RCT
A study testing Lecture-based learning (LBL), PBL plus LBL and Integrated PBL-CBL-CTTM in people with Medical Education and Endocrine System Diseases, run by Chaohu Hospital of Anhui Medical University at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 22 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Medical Education, Endocrine System Diseases, Critical Illness
- What is being tested?
- Lecture-based learning (LBL), PBL plus LBL and Integrated PBL-CBL-CTTM
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2025to 28 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Full-time internal medicine residents undergoing their first endocrine rotation at the Fourth Affiliated Hospital of Anhui Medical University
- No prior endocrine remedial training or advanced study experience
- No independent management experience with endocrine and metabolic critical cases
- Ability to complete all 12 hours of standardized curriculum and all post-intervention assessments
- Voluntary participation with written informed consent
Who cannot join
- Prior completion of an endocrine rotation or specialized endocrine training
- Prior independent management experience in diabetic ketoacidosis, hyperosmolar hyperglycemic syndrome, thyroid storm, or refractory hypoglycemia
- Inability to complete the full 12-hour teaching schedule due to clinical duties, leave, or rotation transfer
- Concurrent participation in other teaching intervention research projects
- Decline to provide written informed consent or withdrawal before randomization
Trial locations and contacts
1 site in 1 country.
China1 site
The Fourth Affiliated Hospital of Anhui Medical University
Chaohu, Anhui, 238000
About this study
Official title: Online-Offline Integrated Multimodal Teaching Combining PBL, CBL, and CTTM to Enhance Clinical Self-Efficacy in Endocrine and Metabolic Critical Illness Among Internal Medicine Residents: A Convergent Parallel Mixed-Methods Randomized Controlled Trial
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.
Read more
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.
- Being tested
- Lecture-based learning (LBL), PBL plus LBL, Integrated PBL-CBL-CTTM
- Keywords
- Problem-Based Learning, Case-Based Learning, Clinical Self-Efficacy, Internal Medicine Residents, Randomized Controlled Trial
- Medical subject headings
- Endocrine System Diseases, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lecture-based learning (LBL)Behavioural
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.
PBL plus LBLBehavioural
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 PBL-CBL-CTTMBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group (LBL Alone) | Active comparator | 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. Receives: Behavioral: Lecture-based learning (LBL) |
| Experimental Group 1 (PBL+LBL) | Experimental | 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. Receives: Behavioral: PBL plus LBL |
| Experimental Group 2 (Integrated PBL-CBL-CTTM) | Experimental | 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. Receives: Behavioral: Integrated PBL-CBL-CTTM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately post-intervention (upon completion of the 12-hour curriculum)
Secondary outcomes (5)
Theoretical examination score
Closed-book written examination graded by blinded faculty. Total score range: 0-50 points, covering endocrine and metabolic critical illness knowledge.
Measured: 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.
Measured: 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.
Measured: Baseline (pre-intervention) and immediately post-intervention
Teaching satisfaction scale score
5-dimension teaching satisfaction scale (recognition rate and mean score), completed anonymously.
Measured: 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.
Measured: Within 1 week post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study start1 Sep 2025
- Primary completion28 Aug 2026
- Study completion28 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medical EducationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chaohu Hospital of Anhui Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianyong Zhao, Chaohu Hospital of Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07801170
- Sponsor's protocol ID
- KYXM-202508-021
- Other IDs
- AHWJ2025BAp20022, KYXM-202508-021
- Acronym
- PBL-CBL-CTTM
- Status last verified
- Aug 2026
- First submitted
- 28 Aug 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online-Offline Integrated Multimodal Teaching Combining PBL, CBL, and CTTM to Enhance Clinical Self-Efficacy in Endocrine and Metabolic Critical Illness Among Internal Medicine Residents: A Convergent Parallel Mixed-Methods Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07801170
- Acronym / sponsor ID
- PBL-CBL-CTTM / KYXM-202508-021
- Keywords
- Problem-Based Learning, Case-Based Learning, Clinical Self-Efficacy, Internal Medicine Residents, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Chaohu Hospital of Anhui Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 28 Aug 2026 (actual)
- Study completion
- 28 Aug 2026 (actual)
- First posted
- 3 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group (LBL Alone) | Active comparator | Behavioral: Lecture-based learning (LBL)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. |
| Experimental Group 1 (PBL+LBL) | Experimental | Behavioral: PBL plus LBLReceived 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. |
| Experimental Group 2 (Integrated PBL-CBL-CTTM) | Experimental | Behavioral: Integrated PBL-CBL-CTTMReceived 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. |
Who may qualify
- Ages
- 22 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Full-time internal medicine residents undergoing their first endocrine rotation at the Fourth Affiliated Hospital of Anhui Medical University
- No prior endocrine remedial training or advanced study experience
- No independent management experience with endocrine and metabolic critical cases
- Ability to complete all 12 hours of standardized curriculum and all post-intervention assessments
- Voluntary participation with written informed consent
Key exclusion criteria (5 listed)
- Prior completion of an endocrine rotation or specialized endocrine training
- Prior independent management experience in diabetic ketoacidosis, hyperosmolar hyperglycemic syndrome, thyroid storm, or refractory hypoglycemia
- Inability to complete the full 12-hour teaching schedule due to clinical duties, leave, or rotation transfer
- Concurrent participation in other teaching intervention research projects
- Decline to provide written informed consent or withdrawal before randomization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lecture-based learning (LBL)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. | Behavioural | Control Group (LBL Alone) |
| PBL plus LBLPre-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. | Behavioural | Experimental Group 1 (PBL+LBL) |
| Integrated PBL-CBL-CTTMIntegrated 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. | Behavioural | Experimental Group 2 (Integrated PBL-CBL-CTTM) |
Primary outcome
Clinical skills assessment score
Time frame: Immediately post-intervention (upon completion of the 12-hour curriculum)
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.
5 secondary outcomes
Theoretical examination score
Time frame: Immediately post-intervention
General Self-Efficacy Scale (GSES) score
Time frame: Baseline (pre-intervention) and immediately post-intervention
Endocrine High-Risk Management Self-Efficacy Source Questionnaire score
Time frame: Baseline (pre-intervention) and immediately post-intervention
Teaching satisfaction scale score
Time frame: Immediately post-intervention
Focus group interview themes
Time frame: Within 1 week post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lecture-based learning (LBL), PBL plus LBL and Integrated PBL-CBL-CTTM in people with Medical Education and Endocrine System Diseases, run by Chaohu Hospital of Anhui Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical skills assessment score (time frame: Immediately post-intervention (upon completion of the 12-hour curriculum)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.