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

November 16, 2019 updated by: EULIS Colloborative Research Working Group

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

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
patient compliance rate of metabolic evaluation
Time Frame: 30 days
the rate of the patients undergo metabolic evaluation tests will be determined
30 days
patient compliance rate of dietary suggestions
Time Frame: 6 months
the rate of the patients that follow the dietary suggestions will be determined
6 months
patient compliance rate of drug treatments
Time Frame: 6 months
the rate of the patients that have the prescribed drugs will be determined
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
factors associated with non-compliance to metabolic evaluation
Time Frame: 3 months
the factors that are related to poor patient compliance to metabolic evaluation will be determined in multivariate analysis
3 months
factors associated with non-compliance to dietary suggestions
Time Frame: 3 months
the factors that are related to poor patient compliance to dietary suggestions will be determined in multivariate analysis
3 months
factors associated with non-compliance to medications
Time Frame: 3 months
the factors that are related to poor patient compliance to medications will be determined in multivariate analysis
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EULIS Colloborative Research Working Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

January 1, 2020

Primary Completion (ANTICIPATED)

December 1, 2020

Study Completion (ANTICIPATED)

February 1, 2021

Study Registration Dates

First Submitted

November 16, 2019

First Submitted That Met QC Criteria

November 16, 2019

First Posted (ACTUAL)

November 19, 2019

Study Record Updates

Last Update Posted (ACTUAL)

November 19, 2019

Last Update Submitted That Met QC Criteria

November 16, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • eCORE-S-19-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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