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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02156921
Other study ID # H-3-2014-FSP17
Secondary ID
Status Completed
Phase N/A
First received May 27, 2014
Last updated October 26, 2016
Start date May 2014
Est. completion date October 2015

Study information

Verified date October 2016
Source Rigshospitalet, Denmark
Contact n/a
Is FDA regulated No
Health authority Denmark: The Regional Committee on Biomedical Research Ethics
Study type Interventional

Clinical Trial Summary

This study aims to investigate the cost-effectiveness of app-based self-directed ultrasound training compared to self-directed training with written handouts on subsequent performance on simulated patient cases and theoretical cases.


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date October 2015
Est. primary completion date June 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- First year medical doctor

- Provided written informed consent

Exclusion Criteria:

- Prior practical ultrasonography experience such as performing independent ultrasonography scans, or participation in any post-graduate ultrasonography courses.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research


Related Conditions & MeSH terms


Intervention

Other:
App-based training


Locations

Country Name City State
Denmark Copenhagen Academy for Medical Education and Simulation Copenhagen Capital Region

Sponsors (3)

Lead Sponsor Collaborator
Rigshospitalet, Denmark Copenhagen Academy for Medical Education and Simulation, University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Video recording of ultrasound skills, rated by consultant radiologists. The video-recordings of the technical performances are merged with the ultrasonography screen-recordings to one anonymized video-clip. These combined video-clips are rated with the OSAUS rating by two raters. The OSAUS scale (Objective Structured Assessment of Ultrasound Skills) is used for all performance assessments. The raters are consultant radiologists. Ratings are to be completed within three months of performance. Yes
Primary Cost-effectiveness of mobile app guided versus textbook guided training September 2016 No
Secondary Diagnostic accuracy Participants are given five videocases, to assess for eFAST verifiable pathology. On site via checklist, evaluated on average one day after performance. Yes
See also
  Status Clinical Trial Phase
Completed NCT01703975 - The Effects of Virtual Reality Ultrasound Training in Pairs Compared to Training Alone N/A