NCT05661370

Brief Summary

This study aimed to examine if self-paced learning with a novel digital patient-case-based educational platform can increase primary care physicians' diagnostic accuracy of malignant and benign skin lesions on both the level of benign/malignant and the diagnosis level. Secondarily the study aimed to investigate the time spent in reaching this change in proficiency.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 5, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 22, 2022

Completed
Last Updated

July 24, 2023

Status Verified

July 1, 2023

Enrollment Period

2 months

First QC Date

December 5, 2022

Last Update Submit

July 21, 2023

Conditions

Keywords

Digital Learninge-learningMelanomaCarcinomaDermoscopyDermloop

Outcome Measures

Primary Outcomes (1)

  • Multiple-Choice Questionnaire (MCQ) Score

    Participants are given a test before and after the intervention using a skin cancer MCQ test with 12 digital-patient cases. A higher score means better diagnostic proficiency. The primary outcome is the change of this score.

    Before and immediately after intervention (On average 19 days after enrollment)

Secondary Outcomes (2)

  • Diagnostic proficiencies

    During the 8 days of access to the educational mobile application.

  • Time spend

    During the 8 days of access to the educational mobile application.

Study Arms (2)

Intervention

ACTIVE COMPARATOR

Access to educational mobile application for 8 days, diagnosing 500 digital patient-cases.

Other: Dermloop Learn

Control

NO INTERVENTION

Control group receiving no intervention, continuing daily practice.

Interventions

Educational Mobile Application with a library of digital patient-cases and written learning modules the user can access on 36 common skin lesions, both benign and malignant.

Intervention

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary Care Physician who works in General Practice

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AISC Research Fascility

Copenhagen, Danmark, 2700, Denmark

Location

Related Publications (1)

  • Nervil GG, Ternov NK, Vestergaard T, Solvsten H, Chakera AH, Tolsgaard MG, Holmich LR. Improving Skin Cancer Diagnostics Through a Mobile App With a Large Interactive Image Repository: Randomized Controlled Trial. JMIR Dermatol. 2023 Aug 9;6:e48357. doi: 10.2196/48357.

MeSH Terms

Conditions

MelanomaCarcinoma

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue DiseasesNeoplasms, Glandular and Epithelial

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Intervention and Controlgroup parallel design using sequential continues block randomization.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

December 5, 2022

First Posted

December 22, 2022

Study Start

November 15, 2021

Primary Completion

January 15, 2022

Study Completion

August 15, 2022

Last Updated

July 24, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will share

Participant quiz-answer data can be shared upon reasonable request.

Time Frame
After publication
Access Criteria
Researchers with interest in skin cancer diagnostics.
More information

Locations