Metabolic EvaluationNCT03048864
Questionnaire for Metabolic Screening
An observational study of Metabolic Evaluation, run by University of British Columbia at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Metabolic Evaluation
- How many people
- 500 participants
- Where
- 1 siteCanada
- Study dates
- 27 Oct 2017to 1 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older 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.
Who may be able to join
- at least 19 years of age, with at least 1 stone episode, ability to consent
Who cannot join
- inability to provide informed consent, under 19 years of age
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
University of British Columbia
Vancouver, British Columbia, V5Z 1M9
Thomas J Grgic, BSc, 6048754111 ext. 62421, thomas.grgic@alumni.ubc.ca
Jonathan Lim, BSc, 6048754111 ext. 62421, lim.jonathan@alumni.ubc.ca
About this study
Official title: Use of Metabolic Evaluations for Patients With Renal Calculi and the Risk of Recurrence
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.
Read the 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.
- Conditions
- Metabolic Evaluation
- Keywords
- Metabolic Screening, 24 hour urine
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic Evaluation
Number of participants that did not receive metabolic evaluations based on Canadian Urologic Association (CUA) criteria
Measured: through study completion - an average of 10 months
Secondary outcomes (2)
Doctor Patient Communication
Number of Participants that received metabolic evaluations but did not have the results adequately explained to them
Measured: at the end of study completion - an average of 10 months
Patient Dietary/Treatment Compliance
Number of patients willing to comply with dietary/treatment advice based on the results of the metabolic evaluations
Measured: at the end of study completion - an average of 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2017 (estimated)
- Study start27 Oct 2017
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic EvaluationStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Université de Montréal, McGill University, Dalhousie University, University of Toronto, University of Alberta
- Responsible party
- Principal investigator, Ben Chew, MD, University of British Columbia
- Investigators
- Nhaeem Bhojani, MD, Principal investigator, Université de MontréalBen H Chew, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03048864
- Sponsor's protocol ID
- H16-03324
- Status last verified
- May 2022
- First submitted
- 1 Feb 2017
- Last updated
- 17 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Metabolic Evaluations for Patients With Renal Calculi and the Risk of Recurrence
- ClinicalTrials.gov ID
- NCT03048864
- Acronym / sponsor ID
- H16-03324
- Conditions
- Metabolic Evaluation
- Keywords
- Metabolic Screening, 24 hour urine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Université de Montréal, McGill University, Dalhousie University, University of Toronto, University of Alberta
- Study start
- 27 Oct 2017 (actual)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 9 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (1 listed)
- at least 19 years of age, with at least 1 stone episode, ability to consent
Key exclusion criteria (1 listed)
- inability to provide informed consent, under 19 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Metabolic Evaluation
Time frame: through study completion - an average of 10 months
Number of participants that did not receive metabolic evaluations based on Canadian Urologic Association (CUA) criteria
2 secondary outcomes
Doctor Patient Communication
Time frame: at the end of study completion - an average of 10 months
Patient Dietary/Treatment Compliance
Time frame: at the end of study completion - an average of 10 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nhaeem Bhojani, MD principal investigator
Université de Montréal
Ben H Chew, MD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Evaluation, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nhaeem Bhojani, MD (514-861-0213, naeem.bhojani.chum@ssss.gouv.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolic Evaluation (time frame: through study completion - an average of 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2022.