Kidney CalculiNCT04169165
Patient Compliance for Metabolic Evaluation and Medical Management in Calcium Stone Patients
An observational study of Kidney Calculi and Nephrolithiasis, run by EULIS Colloborative Research Working Group.
Trial summary
Calcium oxalate stone, the most common type worldwide, has a recurrence rate of around 50% in ten years. Therefore, identifying the underlying pathophysiological aspects via metabolic evaluation and suggestions for medical \& dietary prophylaxis in calcium stone patients is of upmost importance. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Kidney Calculi, Nephrolithiasis, Patient Compliance
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Jan 2020to Feb 2021
- How long will I take part?
- 6 Months
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult patients diagnosed with a calcium oxalate kidney stones and suggested for metabolic evaluation and dietary and/or medical management will be enrolled in the study.
Who may be able to join
- Diagnosis of calcium oxalate kidney stones
- Suggested metabolic evaluation for kidney stone
- Suggested dietary and/or medical treatment for kidney stone
- Accepted participation in the study
Who cannot join
- Age less than 18
- Mental disorders
Trial locations and contacts
No sites are listed yet.
About this study
Official title: How to Improve Patient Compliance for Metabolic Evaluation and Medical & Dietary Prophylaxis in Calcium Stone Patients?
Calcium oxalate stone, the most common type worldwide, has a recurrence rate of around 50% in ten years. Therefore, identifying the underlying pathophysiological aspects via metabolic evaluation and suggestions for medical \& dietary prophylaxis in calcium stone patients is of upmost importance.
However, one of the greatest problem with metabolic evaluation and subsequent therapeutic advices is the patient compliance. Therefore, it is important to identify factors related to patient compliance for metabolic evaluation and medical \& dietary prophylaxis in calcium stone patients
Read the detailed description
Nephrolithiasis is an important health problem that can deteriorate the renal functions in long term and affects the patients' quality of life. One of the major problems about renal stones is the high rate of recurrence. Calcium oxalate stone, the most common type worldwide, has a recurrence rate of around 50% in ten years. Therefore, identifying the underlying pathophysiological aspects via metabolic evaluation and suggestions for medical \& dietary prophylaxis in calcium stone patients is of upmost importance.
However, one of the greatest problem with metabolic evaluation and subsequent therapeutic advices is the patient compliance. In the previous studies, even in case of a dedicated stone clinic, the drop out rate for preventive measures were over 37% per year. The patients' non-compliance may be related to a number of factors associated with the stone clinic, demographic characteristics of the patients, past medical history of the patients, and even the recommended tests and the therapeutic advices.
Therefore, it is important to identify factors related to patient compliance for metabolic evaluation and medical \& dietary prophylaxis in calcium stone patients
Methods:
Parameters to be recorded
Age Gender Level of education
- of stone episodes
- of surgical intervention Type of surgical intervention History of SWL Concomitant diseases Other medications Type of metabolic evaluation (24 hour urine, spot morning urine, serum etc.) Drug for medical prophylaxis Dosage of medication (bid/tid, etc.) Side effects Dietary recommendations Compliance to metabolic evaluation Compliance to medical treatment
Statistics:
Patients will be grouped based on:
compliance to metabolic evaluation compliance to medical treatment
The parameters listed above will be compared between the groups with univariate analysis (logistic regression).
- Keywords
- kidney stone, calcium oxalate stone, patient compliance, nephrolithiasis
- Medical subject headings
- Kidney Calculi, Nephrolithiasis, Patient Compliance, Nephrolithiasis, Calcium Oxalate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| compliant patients | Patients with compliance to suggestions on metabolic evaluation and dietary/medical advices | |
| non-compliant patient | Patients without compliance to suggestions on metabolic evaluation and dietary/medical advices |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient compliance rate of metabolic evaluation
the rate of the patients undergo metabolic evaluation tests will be determined
Measured: 30 days
patient compliance rate of dietary suggestions
the rate of the patients that follow the dietary suggestions will be determined
Measured: 6 months
patient compliance rate of drug treatments
the rate of the patients that have the prescribed drugs will be determined
Measured: 6 months
Secondary outcomes (3)
factors associated with non-compliance to metabolic evaluation
the factors that are related to poor patient compliance to metabolic evaluation will be determined in multivariate analysis
Measured: 3 months
factors associated with non-compliance to dietary suggestions
the factors that are related to poor patient compliance to dietary suggestions will be determined in multivariate analysis
Measured: 3 months
factors associated with non-compliance to medications
the factors that are related to poor patient compliance to medications will be determined in multivariate analysis
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2019
- Study startJan 2020 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionFeb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Kidney CalculiStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- EULIS Colloborative Research Working Group
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04169165
- Sponsor's protocol ID
- eCORE-S-19-001
- Status last verified
- Nov 2019
- First submitted
- 16 Nov 2019
- Last updated
- 19 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All centers will enter their data for every single patient to an online database. The participating centers will be provided a username and a password to enter to the system. All centers will see the data of their own patients and only the number of patients enrolled from other centers.
Publications
Hess B. Renal stone clinic survey: calcium stone formers' self-declared understanding of and adherence to physician's recommendations. Urolithiasis. 2017 Aug;45(4):363-370. doi: 10.1007/s00240-016-0916-3. Epub 2016 Aug 29.
PubMed 27573100Prezioso D, Strazzullo P, Lotti T, Bianchi G, Borghi L, Caione P, Carini M, Caudarella R, Ferraro M, Gambaro G, Gelosa M, Guttilla A, Illiano E, Martino M, Meschi T, Messa P, Miano R, Napodano G, Nouvenne A, Rendina D, Rocco F, Rosa M, Sanseverino R, Salerno A, Spatafora S, Tasca A, Ticinesi A, Travaglini F, Trinchieri A, Vespasiani G, Zattoni F; CLU Working Group. Dietary treatment of urinary risk factors for renal stone formation. A review of CLU Working Group. Arch Ital Urol Androl. 2015 Jul 7;87(2):105-20. doi: 10.4081/aiua.2015.2.105.
PubMed 26150027Trinchieri A. Diet and renal stone formation. Minerva Med. 2013 Feb;104(1):41-54.
PubMed 23392537Skolarikos A, Straub M, Knoll T, Sarica K, Seitz C, Petrik A, Turk C. Metabolic evaluation and recurrence prevention for urinary stone patients: EAU guidelines. Eur Urol. 2015 Apr;67(4):750-63. doi: 10.1016/j.eururo.2014.10.029. Epub 2014 Nov 20.
PubMed 25454613Bensalah K, Tuncel A, Raman JD, Bagrodia A, Pearle M, Lotan Y. How physician and patient perceptions differ regarding medical management of stone disease. J Urol. 2009 Sep;182(3):998-1004. doi: 10.1016/j.juro.2009.05.025. Epub 2009 Jul 18.
PubMed 19616801Parks JH, Asplin JR, Coe FL. Patient adherence to long-term medical treatment of kidney stones. J Urol. 2001 Dec;166(6):2057-60.
PubMed 11696706Dauw CA, Yi Y, Bierlein MJ, Yan P, Alruwaily AF, Ghani KR, Wolf JS Jr, Hollenbeck BK, Hollingsworth JM. Medication Nonadherence and Effectiveness of Preventive Pharmacological Therapy for Kidney Stones. J Urol. 2016 Mar;195(3):648-52. doi: 10.1016/j.juro.2015.10.082. Epub 2015 Oct 17.
PubMed 26485048Pietrow P, Auge BK, Weizer AZ, Delvecchio FC, Silverstein AD, Mathias B, Albala DM, Preminger GM. Durability of the medical management of cystinuria. J Urol. 2003 Jan;169(1):68-70. doi: 10.1016/S0022-5347(05)64037-2.
PubMed 12478105
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How to Improve Patient Compliance for Metabolic Evaluation and Medical & Dietary Prophylaxis in Calcium Stone Patients?
- ClinicalTrials.gov ID
- NCT04169165
- Acronym / sponsor ID
- eCORE-S-19-001
- Keywords
- kidney stone, calcium oxalate stone, patient compliance, nephrolithiasis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- EULIS Colloborative Research Working GroupResearch network
- Study start
- Jan 2020 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Feb 2021 (estimated)
- First posted
- 19 Nov 2019 (actual)
- 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.
Calcium oxalate stone, the most common type worldwide, has a recurrence rate of around 50% in ten years. Therefore, identifying the underlying pathophysiological aspects via metabolic evaluation and suggestions for medical \& dietary prophylaxis in calcium stone patients is of upmost importance.
However, one of the greatest problem with metabolic evaluation and subsequent therapeutic advices is the patient compliance. Therefore, it is important to identify factors related to patient compliance for metabolic evaluation and medical \& dietary prophylaxis in calcium stone patients
Detailed description
Nephrolithiasis is an important health problem that can deteriorate the renal functions in long term and affects the patients' quality of life. One of the major problems about renal stones is the high rate of recurrence. Calcium oxalate stone, the most common type worldwide, has a recurrence rate of around 50% in ten years. Therefore, identifying the underlying pathophysiological aspects via metabolic evaluation and suggestions for medical \& dietary prophylaxis in calcium stone patients is of upmost importance.
However, one of the greatest problem with metabolic evaluation and subsequent therapeutic advices is the patient compliance. In the previous studies, even in case of a dedicated stone clinic, the drop out rate for preventive measures were over 37% per year. The patients' non-compliance may be related to a number of factors associated with the stone clinic, demographic characteristics of the patients, past medical history of the patients, and even the recommended tests and the therapeutic advices.
Therefore, it is important to identify factors related to patient compliance for metabolic evaluation and medical \& dietary prophylaxis in calcium stone patients
Methods:
Parameters to be recorded
Age Gender Level of education
- of stone episodes
- of surgical intervention Type of surgical intervention History of SWL Concomitant diseases Other medications Type of metabolic evaluation (24 hour urine, spot morning urine, serum etc.) Drug for medical prophylaxis Dosage of medication (bid/tid, etc.) Side effects Dietary recommendations Compliance to metabolic evaluation Compliance to medical treatment
Statistics:
Patients will be grouped based on:
compliance to metabolic evaluation compliance to medical treatment
The parameters listed above will be compared between the groups with univariate analysis (logistic regression).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| compliant patients | – | –Patients with compliance to suggestions on metabolic evaluation and dietary/medical advices |
| non-compliant patient | – | –Patients without compliance to suggestions on metabolic evaluation and dietary/medical advices |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients diagnosed with a calcium oxalate kidney stones and suggested for metabolic evaluation and dietary and/or medical management will be enrolled in the study.
Key inclusion criteria (4 listed)
- Diagnosis of calcium oxalate kidney stones
- Suggested metabolic evaluation for kidney stone
- Suggested dietary and/or medical treatment for kidney stone
- Accepted participation in the study
Key exclusion criteria (2 listed)
- Age less than 18
- Mental disorders
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
patient compliance rate of metabolic evaluation
Time frame: 30 days
the rate of the patients undergo metabolic evaluation tests will be determined
patient compliance rate of dietary suggestions
Time frame: 6 months
the rate of the patients that follow the dietary suggestions will be determined
patient compliance rate of drug treatments
Time frame: 6 months
the rate of the patients that have the prescribed drugs will be determined
3 secondary outcomes
factors associated with non-compliance to metabolic evaluation
Time frame: 3 months
factors associated with non-compliance to dietary suggestions
Time frame: 3 months
factors associated with non-compliance to medications
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2019.
- Results publication: PubMed 27573100Hess B. Renal stone clinic survey: calcium stone formers' self-declared understanding of and adherence to physician's recommendations. Urolithiasis. 2017 Aug;45(4):363-370. doi: 10.1007/s00240-016-0916-3. Epub 2016 Aug 29.
- Results publication: PubMed 26150027Prezioso D, Strazzullo P, Lotti T, Bianchi G, Borghi L, Caione P, Carini M, Caudarella R, Ferraro M, Gambaro G, Gelosa M, Guttilla A, Illiano E, Martino M, Meschi T, Messa P, Miano R, Napodano G, Nouvenne A, Rendina D, Rocco F, Rosa M, Sanseverino R, Salerno A, Spatafora S, Tasca A, Ticinesi A, Travaglini F, Trinchieri A, Vespasiani G, Zattoni F; CLU Working Group. Dietary treatment of urinary risk factors for renal stone formation. A review of CLU Working Group. Arch Ital Urol Androl. 2015 Jul 7;87(2):105-20. doi: 10.4081/aiua.2015.2.105.
- Results publication: PubMed 23392537Trinchieri A. Diet and renal stone formation. Minerva Med. 2013 Feb;104(1):41-54.
- Results publication: PubMed 25454613Skolarikos A, Straub M, Knoll T, Sarica K, Seitz C, Petrik A, Turk C. Metabolic evaluation and recurrence prevention for urinary stone patients: EAU guidelines. Eur Urol. 2015 Apr;67(4):750-63. doi: 10.1016/j.eururo.2014.10.029. Epub 2014 Nov 20.
- Results publication: PubMed 19616801Bensalah K, Tuncel A, Raman JD, Bagrodia A, Pearle M, Lotan Y. How physician and patient perceptions differ regarding medical management of stone disease. J Urol. 2009 Sep;182(3):998-1004. doi: 10.1016/j.juro.2009.05.025. Epub 2009 Jul 18.
- Results publication: PubMed 11696706Parks JH, Asplin JR, Coe FL. Patient adherence to long-term medical treatment of kidney stones. J Urol. 2001 Dec;166(6):2057-60.
- Results publication: PubMed 26485048Dauw CA, Yi Y, Bierlein MJ, Yan P, Alruwaily AF, Ghani KR, Wolf JS Jr, Hollenbeck BK, Hollingsworth JM. Medication Nonadherence and Effectiveness of Preventive Pharmacological Therapy for Kidney Stones. J Urol. 2016 Mar;195(3):648-52. doi: 10.1016/j.juro.2015.10.082. Epub 2015 Oct 17.
- Results publication: PubMed 12478105Pietrow P, Auge BK, Weizer AZ, Delvecchio FC, Silverstein AD, Mathias B, Albala DM, Preminger GM. Durability of the medical management of cystinuria. J Urol. 2003 Jan;169(1):68-70. doi: 10.1016/S0022-5347(05)64037-2.
- Individual participant dataSharing planned: No. All centers will enter their data for every single patient to an online database. The participating centers will be provided a username and a password to enter to the system. All centers will see the data of their own patients and only the number of patients enrolled from other centers.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Calculi and Nephrolithiasis, run by EULIS Colloborative Research Working Group.
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 4 inclusion and 2 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 19 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
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 Mehmet I Gökce, MD (+905333669130, migokce@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
patient compliance rate of metabolic evaluation (time frame: 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04169165, which also lists 8 linked publications.
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 19 Nov 2019.