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

This study is currently recruiting participants.
Verified January 2012 by Universitaire Ziekenhuizen Leuven
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01509027
First received: January 9, 2012
Last updated: May 29, 2012
Last verified: January 2012
History of Changes
  Purpose

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.


Condition Intervention
Chronic Kidney Disease
 Behavioral: education by DVD
Behavioral: Standard care
Behavioral: Education by DVD and dietician

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

Resource links provided by NLM:

Drug Information available for: Phosphorus
U.S. FDA Resources

Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • compliance [ Time Frame: baseline and after intervention ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    impact of education (by DVD and interview with dietician) on serum phosphate levels


Secondary Outcome Measures:
  • risk factors of noncompliance [ Time Frame: baseline ] [ Designated as safety issue: No ]
    identification of risk factors for non compliance with emphasis on cognitive function and depression


Estimated Enrollment: 150
Study Start Date: January 2012
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
 Behavioral: 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
 Behavioral: education by DVD
Information on detrimental conseqences of hyperphosphatemia is presented on DVD
Placebo Comparator: Standard Care
standard care
 Behavioral: Standard care
standard care

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01509027

Contacts
Contact: Pieter Evenepoel, MD 003216344580 pieter.evenepoel@uz.kuleuven.ac.be

Locations
Belgium
University Hospitals Leuven Recruiting
Leuven, Belgium, 3000
Sub-Investigator: Pieter Evenepoel            
Principal Investigator: Fabienne Dobbels            
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
  More Information

No publications provided

Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01509027     History of Changes
Other Study ID Numbers: B322201112895
Study First Received: January 9, 2012
Last Updated: May 29, 2012
Health Authority: Belgium: Ethics Committee

Keywords provided by Universitaire Ziekenhuizen Leuven:
hemodialysis
hyperphoshatemia
compliance

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on June 18, 2013