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Patient Compliance for Metabolic Evaluation and Medical Management in Calcium Stone Patients

How to Improve Patient Compliance for Metabolic Evaluation and Medical & Dietary Prophylaxis in Calcium Stone Patients?

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04169165
Enrollment
500
Registered
2019-11-19
Start date
2020-01-31
Completion date
2021-02-28
Last updated
2019-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Calcium Oxalate Urolithiasis, Kidney Calculi, Nephrolithiasis, Patient Compliance

Keywords

kidney stone, calcium oxalate stone, patient compliance, nephrolithiasis

Brief 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. 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).

Interventions

None listed

Sponsors

EULIS Colloborative Research Working Group
Lead SponsorNETWORK

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* Age less than 18 * Mental disorders

Design outcomes

Primary

MeasureTime frameDescription
patient compliance rate of metabolic evaluation30 daysthe rate of the patients undergo metabolic evaluation tests will be determined
patient compliance rate of dietary suggestions6 monthsthe rate of the patients that follow the dietary suggestions will be determined
patient compliance rate of drug treatments6 monthsthe rate of the patients that have the prescribed drugs will be determined

Secondary

MeasureTime frameDescription
factors associated with non-compliance to metabolic evaluation3 monthsthe factors that are related to poor patient compliance to metabolic evaluation will be determined in multivariate analysis
factors associated with non-compliance to dietary suggestions3 monthsthe factors that are related to poor patient compliance to dietary suggestions will be determined in multivariate analysis
factors associated with non-compliance to medications3 monthsthe factors that are related to poor patient compliance to medications will be determined in multivariate analysis

Contacts

Primary ContactMehmet I Gökce, MD
migokce@yahoo.com+905333669130

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026