How to Improve Patient Compliance for Metabolic Evaluation and Medical & Dietary Prophylaxis in Calcium Stone Patients?
Patient Compliance for Metabolic Evaluation and Medical Management in Calcium Stone Patients
Sponsors
Source
EULIS Colloborative Research Working Group
Oversight Info
Has Dmc
No
Is Fda Regulated Drug
No
Is Fda Regulated Device
No
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
2
Enrollment
500
Conditions
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
No
Overall Contact
Verification Date
2019-11-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Sponsor
Keywords
Has Expanded Access
No
Condition Browse
Intervention Browse
Mesh Term
Calcium, Dietary
Calcium
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
Results Reference
Citation
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.
PMID
27573100
Citation
Prezioso 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. Review. Erratum in: Arch Ital Urol Androl. 2016 Mar;88(1):76. Ferraro, Manuel [added].
PMID
26150027
Citation
Trinchieri A. Diet and renal stone formation. Minerva Med. 2013 Feb;104(1):41-54.
PMID
23392537
Citation
Skolarikos A, Straub M, Knoll T, Sarica K, Seitz C, Petřík A, Türk 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.
PMID
25454613
Citation
Bensalah 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.
PMID
19616801
Citation
Parks JH, Asplin JR, Coe FL. Patient adherence to long-term medical treatment of kidney stones. J Urol. 2001 Dec;166(6):2057-60.
PMID
11696706
Citation
Dauw 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.
PMID
26485048
Citation
Pietrow 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.
PMID
12478105
Firstreceived Results Date
N/A
Target Duration
6 Months
Patient Data
Sharing Ipd
No
Ipd 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.
Firstreceived Results Disposition Date
N/A
Study Design Info
Observational Model
Cohort
Time Perspective
Prospective
Study First Submitted
November 16, 2019
Study First Submitted Qc
November 16, 2019
Study First Posted
November 19, 2019
Last Update Submitted
November 16, 2019
Last Update Submitted Qc
November 16, 2019
Last Update Posted
November 19, 2019
ClinicalTrials.gov processed this data on December 10, 2019
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.
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.