Study of the Compliance With Phosphorus Restricted Diet and Phosphate Binder Therapy in Hemodialysis Patients

Chronic Kidney Disease Clinical Trial

Official title:

A Randomized Controlled Trial to Evaluate the Impact of Education on the Knowledge About and Compliance With a Phosphorus Restricted Diet and Phosphate Binder Therapy in Maintenance Dialysis Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01509027
• Other study ID #: B322201112895
• Status: Recruiting
• Phase: N/A
• First received: January 9, 2012
• Last updated: May 29, 2012
• Start date: January 2012
• Est. completion date: June 2012

Study information

• Verified date: January 2012
• Source: Universitaire Ziekenhuizen Leuven
• Contact: Pieter Evenepoel, MD
• Phone: 003216344580
• Email: pieter.evenepoel[@]uz.kuleuven.ac.be
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Hyperphosphatemia is a common and severe complication in chronic kidney disease patients treated with hemodialysis. A phosphate restricted diet and oral phosphate binders are the cornerstones in the prevention and treatment of this complication. However, noncompliance is an prevalent problem resulting in poorly controled hyperphosphatemia in a substantial proportion of hemodialysis patients. The present study aims at identifying risk factors for non compliance and also test the hypothesis that compliance can be improved by education patients on the consequences of hyperphosphatemia and the importance of diet and phosphate binder therapy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• prevalent (>3months) hemodialysis patients

• aged > 18 years

• informed consent

Exclusion Criteria:

• decreased consciousness

• unstable

• medical contraindication for phosphorus restricted diet or phsophate binder therapy

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Behavioral:
• education by DVD
Information on detrimental conseqences of hyperphosphatemia is presented on DVD
• Standard care
standard care
• Education by DVD and dietician
Information on detrimental conseqences of hyperphosphatemia is presented on DVD and individual dietary counseling is given by dieticican

Locations

Country	Name	City	State
Belgium	University Hospitals Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	compliance	impact of education (by DVD and interview with dietician)on compliance with phosphorus restricted diet and phosphate binder therapy	baseline and after intervention	No
Primary	serum phosphate levels	impact of education (by DVD and interview with dietician) on serum phosphate levels	baseline and after intervention	No
Secondary	risk factors of noncompliance	identification of risk factors for non compliance with emphasis on cognitive function and depression	baseline	No