NCT03408288

Brief Summary

The investigators hypothesize that incorporation of a colorimetric scale on urine collection bags to estimate degree of hematuria would allow better characterization of urine by healthcare staff thus leading to improved patient care.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2018

Shorter than P25 for all trials

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

January 16, 2018

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 17, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 24, 2018

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

July 3, 2018

Status Verified

January 1, 2018

Enrollment Period

16 days

First QC Date

January 17, 2018

Last Update Submit

July 2, 2018

Conditions

Hematuria

Outcome Measures

Primary Outcomes (3)

  • Intra-user concordance in assessment of hematuria score measured by Hemapoche

    Kappa coefficient

    Baseline

  • Intra-user concordance in assessment of hematuria score measured by Hemostick

    Kappa coefficient

    Baseline

  • Intra-user concordance in assessment of hematuria described by color of urine

    Kappa coefficient

    Baseline

Secondary Outcomes (8)

  • Concordance between nurses versus doctors in assessment of hematuria score measured by Hemapoche

    Baseline

  • Concordance between nurses versus doctors in assessment of hematuria score measured by Hemastick

    Baseline

  • Concordance between nurses versus doctors in assessment of hematuria described by color

    Baseline

  • Time needed to characterize hematuria when using Hemapoche

    Baseline

  • Time needed to characterize hematuria when using Hemostick

    Baseline

  • +3 more secondary outcomes

Study Arms (2)

Nurses

Other: HemapocheOther: HemastickOther: Color description

Urologists

Other: HemapocheOther: HemastickOther: Color description

Interventions

HemapocheOTHER

Use of Hemapoche scale to assess hematuria in reference samples

NursesUrologists
HemastickOTHER

Use of Hemastick scale to assess hematuria in reference samples

NursesUrologists
Color descriptionOTHER

Describe color of reference sample

NursesUrologists

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Nurses volunteering to take part in the study outside of the urology department of CHU Nimes and a panel of urologist experts

You may qualify if:

  • The participant is at least 18 year old
  • Nurses recruited voluntarily in the CHU Nimes outside of the Urology department of any duration of experience
  • Urologist working in the Languedoc-Roussillon region

You may not qualify if:

  • The participant has color-blindness
  • Nurse or urologist from the urology department of Nimes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Nimes

Nîmes, 30029, France

Location

MeSH Terms

Conditions

Hematuria

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Armand Chevrot, MD

    CHU Nimes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2018

First Posted

January 24, 2018

Study Start

January 16, 2018

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

July 3, 2018

Record last verified: 2018-01

Locations

FR(1)