Questionnaire for Metabolic Screening | NCT03048864

Studies
Questionnaire for Metabolic Screening

NCT03048864

Sponsor

University of British Columbia

Status

Unknown status

Last Update Posted

May 17, 2022Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Metabolic Evaluation

Interventions

Not provided

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 27, 2017Actual

Primary Completion Date

Oct 1, 2023Estimated

Completion Date

Oct 1, 2023Estimated

First Submitted Date

Feb 1, 2017

First Submission Date that Met QC Criteria

Feb 7, 2017

First Posted Date

Feb 9, 2017Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 16, 2022

Last Update Posted Date

May 17, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ben Chew, MD, Associate Professor, University of British ColumbiaPrincipal Investigator

Lead Sponsor

University of British ColumbiaOTHER

Collaborators

Name	Class
Université de Montréal	OTHER
McGill University	OTHER
Dalhousie University	OTHER
University of Toronto

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

PURPOSE:

The purpose of the project is to determine whether metabolic workups are administered to Canadian kidney stone patients in accordance to CUA (Canadian Urologic Association) guidelines. Additionally, the study will look to evaluate whether the results of metabolic tests were sufficiently explained to patients by their doctors, and also whether or not patients would follow dietary or treatment plans to possibly prevent kidney stones based on these metabolic workups.

HYPOTHESIS:

The investigators hypothesize that the implementation of metabolic tests based on CUA guidelines is sub-optimal and that when they are prescribed, doctors do not adequately explain these results to patients. The investigators also hypothesize that patients would follow dietary and treatment plants to prevent recurrent stone formation based on these metabolic results - if they are prescribed to the patient.

JUSTIFICATION:

The investigators believe that implementation of metabolic workups is sub-optimal. The investigators would like to confirm this so that, in the future, metabolic workups can be promoted as an appropriate tool for identifying metabolic abnormalities that contribute to stone disease. If metabolic workups are administered and explained adequately to patients then further diet or treatment plans can significantly reduce recurrence of stones in stone patients.

OBJECTIVES:

Determine if metabolic workups were administered when they should have been according to CUA guidelines.
For patients who received metabolic workups, determine if the results from metabolic workups were explained to patients, and if so was it done adequately (did the patient understand the explanation)
Determine patient compliance regarding dietary and treatment plans based on metabolic workups

RESEARCH DESIGN:

This is a survey based study (one time completion) given to patients pre-ESWL. The surveys will be analyzed by research staff to determine the study objectives.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Doctor Patient Communication	Number of Participants that received metabolic evaluations but did not have the results adequately explained to them	at the end of study completion - an average of 10 months
Patient Dietary/Treatment Compliance

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

inability to provide informed consent, under 19 years of age

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Nhaeem Bhojani, MD	Contact	514-861-0213		naeem.bhojani.chum@ssss.gouv.qc.ca
Thomas J Grgic, BSc	Contact	604 875 4111	62421	thomas.grgic@alumni.ubc.ca

Overall Officials

Name	Affiliation	Role
Nhaeem Bhojani, MD	Université de Montréal	Principal Investigator
Ben H Chew, MD	University of British Columbia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of British Columbia	Recruiting	Vancouver	British Columbia	V5Z 1M9	Canada

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided