NCT03048864

Brief Summary

The purpose of this study is to determine if kidney stone patients who should have received metabolic tests (urine collection over 24-hours that determines the composition of urine) based on Canadian Urologic Association (CUA) guidelines did in fact receive them, and if these results were explained to them by their doctor.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

February 1, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 9, 2017

Completed
9 months until next milestone

Study Start

First participant enrolled

October 27, 2017

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

May 17, 2022

Status Verified

May 1, 2022

Enrollment Period

5.9 years

First QC Date

February 1, 2017

Last Update Submit

May 16, 2022

Conditions

Metabolic Evaluation

Keywords

Metabolic Screening24 hour urine

Outcome Measures

Primary Outcomes (1)

  • Metabolic Evaluation

    Number of participants that did not receive metabolic evaluations based on Canadian Urologic Association (CUA) criteria

    through study completion - an average of 10 months

Secondary Outcomes (2)

  • Doctor Patient Communication

    at the end of study completion - an average of 10 months

  • Patient Dietary/Treatment Compliance

    at the end of study completion - an average of 10 months

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants will be screened prior to extracorporeal shockwave lithotripsy and will have had at least 1 stone episode. Participants will be recruited from Saint-Luc Hospital, VGH Hospital, Glen Hospital, Dartmouth General Hospital, St.Michael's Hospital and University of Alberta Hospital.

You may qualify if:

  • at least 19 years of age, with at least 1 stone episode, ability to consent

You may not qualify if:

  • inability to provide informed consent, under 19 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of British Columbia

Vancouver, British Columbia, V5Z 1M9, Canada

RECRUITING

Study Officials

  • Nhaeem Bhojani, MD

    Université de Montréal

    PRINCIPAL INVESTIGATOR

  • Ben H Chew, MD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nhaeem Bhojani, MD

CONTACT

514-861-0213naeem.bhojani.chum@ssss.gouv.qc.ca

Thomas J Grgic, BSc

CONTACT

604 875 4111thomas.grgic@alumni.ubc.ca

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 1, 2017

First Posted

February 9, 2017

Study Start

October 27, 2017

Primary Completion

October 1, 2023

Study Completion

October 1, 2023

Last Updated

May 17, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)