NCT05620186

Brief Summary

The goal of this multicentric registry is to gather data from trainees completing PROSPECT: a PROficiency Based StePwise Endovascular Curricular Training to obtain basic cognitive and technical skills. The main goals are to identify if:

  • Results from a previous randomised controlled trail can be reproduced in real life.
  • Evaluate skills retention after program completion.
  • Assess real life implementation of the training program.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
16mo left

Started Oct 2017

Longer than P75 for not_applicable

Geographic Reach
2 countries

3 active sites

Status
recruiting

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 Progress87%
Oct 2017Oct 2027

Study Start

First participant enrolled

October 17, 2017

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

November 2, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 17, 2022

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

December 9, 2024

Status Verified

December 1, 2024

Enrollment Period

10 years

First QC Date

November 2, 2022

Last Update Submit

December 4, 2024

Conditions

Vascular Diseases

Keywords

simulation based educationendovascular procedures

Outcome Measures

Primary Outcomes (2)

  • Cognitive skills

    Multiple Choice Question test (min: 0, max: 20, the higher the score, the better)

    comparison before program start and after completion. This means through study completion.

  • Technical skills

    Rating scale assessment and simulator metrics

    comparison before program start and after completion. This means through study completion.

Secondary Outcomes (2)

  • Cognitive skills retention

    3, 6 and 12 months after program completion

  • Technical skills retention

    3, 6 and 12 months after program completion

Study Arms (2)

Original PROSPECT

OTHER

Original, distributed PROSPECT where trainees learn at their own pace in between, before/after clinical activities

Other: PROSPECT

Massed PROSPECT

OTHER

Massed, bootcamp-style training form of PROSPECT where trainees are exempt from clinical duties

Other: PROSPECT

Interventions

PROSPECTOTHER

PROficiency Based StePwise Endovascular Curricular Training

Massed PROSPECTOriginal PROSPECT

Eligibility Criteria

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

You may qualify if:

  • Surgical trainee
  • Knowledge and technical skill level evaluated
  • Demographics questionnaire and general MCQ test completed
  • Endovascular simulated exercise completed after familiarization with the simulator

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University Hospital Ghent

Ghent, 9000, Belgium

RECRUITING

KU Leuven

Leuven, 3000, Belgium

RECRUITING

CAMES

Copenhagen, 2100, Denmark

RECRUITING

MeSH Terms

Conditions

Vascular Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

  • Isabelle Van Herzeele, MD, PhD

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Isabelle Van Herzeele, MD, PhD

CONTACT

09 332 51 08isabelle.vanherzeele@ugent.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: Registry, no comparison
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2022

First Posted

November 17, 2022

Study Start

October 17, 2017

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2027

Last Updated

December 9, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

BE(2)DK(1)