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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Health Services Research
    • Masking: Single (Participant)
  • Study Primary Completion Date: June 2012

Interventions

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

Arms, Groups and Cohorts

  • Active Comparator: Education by DVD and dietician
    • Information on detrimental conseqences of hyperphosphatemia is presented on DVD and individual dietary counseling is given by dieticican
  • Active Comparator: Education by unpersonalised DVD
    • Information on detrimental consequences of hyperphosphatemia is presented on DVD
  • Placebo Comparator: Standard Care
    • standard care

Clinical Trial Outcome Measures

Primary Measures

  • compliance
    • Time Frame: 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
    • Time Frame: baseline and after intervention
    • impact of education (by DVD and interview with dietician) on serum phosphate levels

Secondary Measures

  • risk factors of noncompliance
    • Time Frame: baseline
    • identification of risk factors for non compliance with emphasis on cognitive function and depression

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Universitaire Ziekenhuizen KU Leuven
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Pieter Evenepoel, MD, 003216344580, pieter.evenepoel@uz.kuleuven.ac.be

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