NCT05087485

Brief Summary

Investigators hypothesize that the introduction of basic science explanations within the instructional design of case-based training in visual diagnostics will improve students' learning curves, retention, and retrieval of knowledge/skill following a washout period. Research question: In a group of medical students with limited dermatological training, what is the effect of integrating biomedical causal explanations of visual criteria during a prolonged case-based skin cancer training program in visual pattern recognition when compared with an identical instructional design without biomedical explanations? How will the displacement of students' cognitive resources from practicing pattern recognition towards understanding the pattern, affect their learning behavior, learning curve (accuracy and time per diagnosis), and retrieval of pattern recognition skills following a washout period? The above-mentioned research questions will be tested through a randomized trial with an allocation ratio of 1:1. All participants will be trained in skin cancer diagnostics through a mobile application that offers simulation training and learning through written modules about the various differential diagnoses. Approximately half of the participants will be subject to a written content that displays the dermoscopic visual criteria without an explanation while the remaining half will be subject to the dermoscopic criteria + an explanation of the underlying cause. The training program consists of 500 training cases, a 14 day wash-out period, and a final training session of 100 cases.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
87

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

July 7, 2021

Completed
3 days until next milestone

Study Start

First participant enrolled

July 10, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 21, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2021

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 22, 2021

Completed
Last Updated

March 16, 2022

Status Verified

March 1, 2022

Enrollment Period

4 months

First QC Date

July 7, 2021

Last Update Submit

March 15, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • Initial learning curve

    Slope and upper plateau of moving average from day 1-7

    7 days

  • Secondary learning curve

    Slope and upper plateau of moving average from day 21-23

    3 days

Secondary Outcomes (3)

  • Reading time during the study

    30 days

  • Number of times the reading material was accessed

    30 days

  • Performance improvement on tests

    30 days

Study Arms (2)

Basic science

EXPERIMENTAL

This group will be exposed to a written learning content that includes both the presentation and underlying reason of dermoscopic criteria

Other: education

visual criteria

EXPERIMENTAL

This group will be exposed to a written learning content that includes only the presentation of dermoscopic criteria

Other: education

Interventions

digital education in skin cancer diagnostics

Basic sciencevisual criteria

Eligibility Criteria

Age22 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Actively enrolled at the Faculty of Health and Medical Sciences University of Copenhagen
  • Passed exams in basic histopathology and cellular physiology

You may not qualify if:

  • former training in dermoscopy or skin cancer diagnostics in general

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Niels Kvorning Ternov

Herlev, Danmark, 2730, Denmark

Location

MeSH Terms

Conditions

MelanomaSkin Neoplasms

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 7, 2021

First Posted

October 21, 2021

Study Start

July 10, 2021

Primary Completion

November 20, 2021

Study Completion

November 22, 2021

Last Updated

March 16, 2022

Record last verified: 2022-03

Locations