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The Effect of Large Versus Small Clog Size on Emergency Response Time

Sponsor
Amsterdam UMC, location VUmc (Other)
Overall Status
Completed
CT.gov ID
NCT04406220
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
2.3
Actual Duration (Months)
21.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In many hospitals, clogs, usually white, are provided for healthcare workers. In our hospital, health care professionals from the department of intensive care medicine may be summoned to an emergency situation on a 24/7 basis. Clogs are thought to be of importance for running. Although clogs are available in several sizes, clog size is typically left to the discretion of the individual healthcare worker. Interestingly,

The primary goal of this randomized controlled trial is to assess if wearing large size clogs as compared to small size clogs results in increased running speed.

Participants will be randomized to small versus large clog size using a using randomly permuted blocks stratified by gender. Following randomization, participants will wear the clogs of allocated size and complete a standardized running course.

The primary endpoint is the time taken to complete the course.

The enrolment of 50 subjects would provide 80% power to show a 5-second difference in the response time at an average response time of 30 seconds with a 6 second standard deviation.

The ethical committee judged the study protocol exempt from extensive review.

Condition or Disease Intervention/Treatment Phase
  • Other: Small clog size
  • Other: Large clog size
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
The Effect of Large Versus Small Clog Size on Healthcare Professional Emergency Response Time: a Randomized Controlled Trial
Actual Study Start Date :
Feb 20, 2020
Actual Primary Completion Date :
Mar 30, 2020
Actual Study Completion Date :
Apr 30, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Small clog size

Other: Small clog size
Participants will be randomized to run in small clogs
Active Comparator: Large clog size

Other: Large clog size
Participants will be randomized to run in large clogs

Outcome Measures

Primary Outcome Measures

  1. Time to complete the running course [Follow-up until 60 minutes.]

    The time to complete the course will be compared between the two groups using a linear model with the randomized allocation and the stratification variable as covariates.

Secondary Outcome Measures

  1. Adverse events [Follow-up until 60 minutes.]

  2. Time to complete the running course for specific subgroups: By gender, job function, level of fitness. [Follow-up until 60 minutes.]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Healthcare workers aged 18 years or older.
Exclusion Criteria:
  • Inability to run on clogs.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Amsterdam UMC, location VUmc Amsterdam Netherlands 1081 HV

Sponsors and Collaborators

  • Amsterdam UMC, location VUmc

Investigators

  • Study Chair: Paul Elbers, MD, PhD, Amsterdam UMC, location VUmc

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
H.J.S. de Grooth, MD, Coordinating investigator, Amsterdam UMC, location VUmc
ClinicalTrials.gov Identifier:
NCT04406220
Other Study ID Numbers:
  • 2019-clog
First Posted:
May 28, 2020
Last Update Posted:
May 28, 2020
Last Verified:
May 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Emergencies
Occupational Injuries

Study Results

No Results Posted as of May 28, 2020