App Teaches Doctors to Diagnose Skin Cancer
Primary Purpose
Melanoma (Skin), Carcinoma
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Dermloop Learn
Sponsored by
About this trial
This is an interventional other trial for Melanoma (Skin) focused on measuring Digital Learning, e-learning, Melanoma, Carcinoma, Dermoscopy, Dermloop
Eligibility Criteria
Inclusion Criteria: Primary Care Physician who works in General Practice Exclusion Criteria: -
Sites / Locations
- AISC Research Fascility
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Intervention
Control
Arm Description
Access to educational mobile application for 8 days, diagnosing 500 digital patient-cases.
Control group receiving no intervention, continuing daily practice.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Diagnostic proficiencies
Sensitivity, Specificity and Positive Predictive Value of the participants in the intervention group, calculated on their cases seen in the educational mobile application.
Time spend
The Dermloop Learn app tracks how much time each user spends quizzing and reading.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05661370
Brief Title
App Teaches Doctors to Diagnose Skin Cancer
Official Title
Improving Diagnostic Accuracy in Skin Cancer Diagnostics Using Educational Mobile App: a Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
November 15, 2021 (Actual)
Primary Completion Date
January 15, 2022 (Actual)
Study Completion Date
August 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Herlev Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Participants were given a questionnaire and an initial Skin Cancer Multiple Choice-Questionnaire (MCQ) to test their diagnostic skills regardining skin and mole cancer and the most common differential diagnoses.
Participants in the Intervention group was then given access to an educational mobile application (App) for 8 days and asked to diagnose 500 patient cases. The participants did so at their own leisure and time.
After 8 days they were asked to abstain from using the App for another 8 days (wash out period) and were then given a Final Skin Cancer Multiple Choice-Questionnaire (MCQ).
Participants of the control group received no intervention nor education during the 16 days of waiting before they took the final Skin Cancer Multiple Choice-Questionnaire.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma (Skin), Carcinoma
Keywords
Digital Learning, e-learning, Melanoma, Carcinoma, Dermoscopy, Dermloop
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Intervention and Controlgroup parallel design using sequential continues block randomization.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
Access to educational mobile application for 8 days, diagnosing 500 digital patient-cases.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control group receiving no intervention, continuing daily practice.
Intervention Type
Other
Intervention Name(s)
Dermloop Learn
Intervention Description
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.
Primary Outcome Measure Information:
Title
Multiple-Choice Questionnaire (MCQ) Score
Description
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.
Time Frame
Before and immediately after intervention (On average 19 days after enrollment)
Secondary Outcome Measure Information:
Title
Diagnostic proficiencies
Description
Sensitivity, Specificity and Positive Predictive Value of the participants in the intervention group, calculated on their cases seen in the educational mobile application.
Time Frame
During the 8 days of access to the educational mobile application.
Title
Time spend
Description
The Dermloop Learn app tracks how much time each user spends quizzing and reading.
Time Frame
During the 8 days of access to the educational mobile application.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Primary Care Physician who works in General Practice
Exclusion Criteria:
-
Facility Information:
Facility Name
AISC Research Fascility
City
Copenhagen
State/Province
Danmark
ZIP/Postal Code
2700
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Participant quiz-answer data can be shared upon reasonable request.
IPD Sharing Time Frame
After publication
IPD Sharing Access Criteria
Researchers with interest in skin cancer diagnostics.
IPD Sharing URL
https://aiscresearch.com/
Learn more about this trial
App Teaches Doctors to Diagnose Skin Cancer
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