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

Not Applicable

• Conditions: Chronic Kidney Disease
• Interventions: Behavioral: Education by DVD and dietician; Behavioral: education by DVD; Behavioral: Standard care

• Registration Number: NCT01509027
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-01
• Study Start: 2012-01
• Study First Submitted: 2012-01-09
• Study First Submitted QC: 2012-01-11
• Study First Posted: 2012-01-12
• Last Update Submitted: 2012-05-29
• Last Update Posted: 2012-05-30
• Primary Completion: 2012-06
• Study Completion: 2012-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Education by DVD and dietician	Education by DVD and dietician	Information on detrimental conseqences of hyperphosphatemia is presented on DVD and individual dietary counseling is given by dieticican
Education by unpersonalised DVD	education by DVD	Information on detrimental consequences of hyperphosphatemia is presented on DVD
Standard Care	Standard care	standard care

Primary Outcome Measures

Name	Time	Method
compliance	baseline and after intervention	impact of education (by DVD and interview with dietician)on compliance with phosphorus restricted diet and phosphate binder therapy
serum phosphate levels	baseline and after intervention	impact of education (by DVD and interview with dietician) on serum phosphate levels

Secondary Outcome Measures

Name	Time	Method
risk factors of noncompliance	baseline	identification of risk factors for non compliance with emphasis on cognitive function and depression

Trial Locations

Locations (1)

University Hospitals Leuven; 🇧🇪 Leuven, Belgium