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Clinical Trials/NCT01509027
NCT01509027UnknownNot Applicable

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

Universitaire Ziekenhuizen KU Leuven2 sites in 1 country150 target enrollmentStarted: January 2012Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
150
Locations
2
Primary Endpoint
compliance

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • prevalent (>3months) hemodialysis patients
  • aged > 18 years
  • informed consent

Exclusion Criteria

  • decreased consciousness
  • medical contraindication for phosphorus restricted diet or phsophate binder therapy

Outcomes

Primary Outcomes

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 Outcomes

  • risk factors of noncompliance(baseline)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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