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

NCT04169165 | Unknown

• 1 other identifier: eCORE-S-19-001
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

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

Conditions

Kidney Calculi; Nephrolithiasis; Patient Compliance; Calcium Oxalate Urolithiasis

Keywords

kidney stone; calcium oxalate stone; patient compliance; nephrolithiasis

Outcome Measures

Primary Outcomes (3)

• patient compliance rate of metabolic evaluation

  the rate of the patients undergo metabolic evaluation tests will be determined

  30 days

• patient compliance rate of dietary suggestions

  the rate of the patients that follow the dietary suggestions will be determined

  6 months

• patient compliance rate of drug treatments

  the rate of the patients that have the prescribed drugs will be determined

  6 months

Secondary Outcomes (3)

• 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

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Age less than 18
• Mental disorders

Sponsors & Collaborators

• EULIS Colloborative Research Working Group: lead

Related Publications (8)

• 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 RESULT

• 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.

  PMID: 26150027 RESULT

• Trinchieri A. Diet and renal stone formation. Minerva Med. 2013 Feb;104(1):41-54.

  PMID: 23392537 RESULT

• Skolarikos A, Straub M, Knoll T, Sarica K, Seitz C, Petrik A, Turk 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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. doi: 10.1016/S0022-5347(05)64037-2.

  PMID: 12478105 RESULT

MeSH Terms

Conditions

Kidney Calculi; Nephrolithiasis; Patient Compliance; Nephrolithiasis, Calcium Oxalate

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Central Study Contacts

Mehmet I Gökce, MD

CONTACT

+905333669130; migokce@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2019
• First Posted: November 19, 2019
• Study Start: January 1, 2020
• Primary Completion: December 1, 2020
• Study Completion: February 1, 2021
• Last Updated: November 19, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share