NCT04261101

Brief Summary

The use of test-enhanced learning with causal connection and in preparation for future learning has been used in health educational setting with positive results. However, most studies were performed in a controlled lab scenario and not in the "real world" of medicine classes, decreasing the external applicability of such experiments. Therefore, the aim of present study is to evaluate if a session of test-enhanced learning at the beginning of endocrinology course, using basic-clinical sciences connections of key concepts, would prepare for future learning of endocrinology on a theory-practical 4-week endocrinology course. Methods Study design, participants and description of undergraduate endocrinology course This is a prospective, single center, non-blinded, RCT. Participants are students of medicine from Universidade Federal do Rio Grande do Sul (UFRGS), Brazil, in their third year of Medical School, recruited at the beginning of endocrinology undergraduate clinical placement. This clinical trial follows the Consolidated Standards of Reporting Trials (CONSORT) statement, which includes the completing the CONSORT checklist. Sample size Based in a previous study, to find a difference in the percentage of correct answers in a cognitive test to evaluate retention of 12%, considering a SD of 26%, alpha error of 5%, beta error of 20%, and repeated assessments (baseline, 3 weeks and 6 months), 35 students will be necessary in each group. To account for possible losses of follow-up, 84 students will be included. Study intervention All students will receive, in advance, a text with basic sciences information relevant to the learning of Endocrinology (supplementary material), with instructions to study the text before intervention day. Students will be randomized to one of the interventions: TEL with questions about diabetes and adrenal (Block A, 6 questions) or thyroid and hypophysis (Block B, 6 questions). Important endocrinology concepts, such as fuel metabolism and circadian rhythm will be included in Block A, and feedback loops and hormone synthesis in Block B. Specific hormone functions will be part of both TEL Blocks. Assessments At the same day of intervention, students will answer all questions 12 of the TEL session (questions from blocks A and B) with best answer multiple choice questions (immediate retention test). After 3 weeks and 6 months, the transfer of knowledge will be assessed with a 24 multiple choice questions test, based in clinical cases.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2020

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

February 1, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 7, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

February 7, 2020

Status Verified

February 1, 2020

Enrollment Period

10 months

First QC Date

January 31, 2020

Last Update Submit

February 6, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 24 multiple choice questions test at 3 weeks

    Scores in 24 multiple choice questions test to assess learning transfer from basic sciences to Endocrinology, in 3 weeks. This is an special designed test. It is not a scale. The score will be zero to 24. The highest score indicates the best performance.

    3 weeks

Secondary Outcomes (4)

  • Immediate retention test

    immediately after test

  • 24 multiple choice questions test at 6 months

    6 months

  • Metacognition questionnaires - professors

    4 weeks

  • Metacognition questionnaires - students

    4 weeks

Study Arms (2)

Block A

EXPERIMENTAL

Test intervention with questions regarding diabetes and adrenal

Other: Test-enhanced learning

Block B

ACTIVE COMPARATOR

Test intervention with questions regarding thyroid and hypophysis

Other: Test-enhanced learning

Interventions

Test-enhanced learning with short answers of questions regarding diabetes and adrenal

Block ABlock B

Eligibility Criteria

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

You may qualify if:

  • Students will be consecutively invited to participated in the study before starting their Endocrinology placement and will be included after agreeing to participate and signing an informed consent

You may not qualify if:

  • Students absent on the day of study intervention or on the four-week assessment will be excluded from analysis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Endocrine System Diseases

Study Officials

  • Cristiane B Leitao, MD

    Hospital de Clínicas de Porto Alegre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cristiane B Leitao, MD

CONTACT

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

January 31, 2020

First Posted

February 7, 2020

Study Start

February 1, 2020

Primary Completion

December 1, 2020

Study Completion

July 1, 2021

Last Updated

February 7, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share