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?

Lead Sponsor

EULIS Colloborative Research Working Group

Source

EULIS Colloborative Research Working Group

Oversight Info

Has Dmc

Is Fda Regulated Drug

Is Fda Regulated Device

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).

Overall Status

Not yet recruiting

Start Date

2020-01-01

Completion Date

2021-02-01

Primary Completion Date

2020-12-01

Study Type

Observational [Patient Registry]

Primary Outcome

Measure	Time Frame
patient compliance rate of metabolic evaluation	30 days
patient compliance rate of dietary suggestions	6 months
patient compliance rate of drug treatments	6 months

Secondary Outcome

Measure	Time Frame
factors associated with non-compliance to metabolic evaluation	3 months
factors associated with non-compliance to dietary suggestions	3 months
factors associated with non-compliance to medications	3 months

Number Of Groups

Enrollment

500

Conditions

Kidney Calculi

, Nephrolithiasis

, Patient Compliance

, Calcium Oxalate Urolithiasis

Eligibility

Study Pop

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.

Sampling Method

Probability Sample

Criteria

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

Gender

All

Minimum Age

18 Years

Maximum Age

80 Years

Healthy Volunteers

Overall Contact

Last Name

Mehmet I Gökce, MD

Phone

+905333669130

Email

[email protected]

Verification Date

2019-11-01

Lastchanged Date

N/A

Firstreceived Date

N/A

Responsible Party

Responsible Party Type

Sponsor

Keywords

kidney stone

, calcium oxalate stone

, patient compliance

, nephrolithiasis

Has Expanded Access

Condition Browse

Urolithiasis

, Nephrolithiasis

, Kidney Calculi

, Calculi

Arm Group

Arm Group Label

compliant patients

Description

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

Arm Group Label

non-compliant patient

Description

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

Firstreceived Results Disposition Date

N/A

Study Design Info

ClinicalTrials.gov processed this data on May 22, 2020

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.

Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.

Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.

ICH GCP | Clinical Trials Registry

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