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

EULIS Colloborative Research Working Group

Status: Unknown

Conditions: Calcium Oxalate Urolithiasis; Patient Compliance; Nephrolithiasis; Kidney Calculi

Study type: Observational

Funder types: NETWORK

Identifiers

NCT04169165

eCORE-S-19-001

Details and patient eligibility

About

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

Full 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).

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

500 participants in 2 patient groups

compliant patients

Description:

Patients with compliance to suggestions on metabolic evaluation and dietary/medical advices

non-compliant patient

Description:

Patients without compliance to suggestions on metabolic evaluation and dietary/medical advices