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

U

Universitaire Ziekenhuizen KU Leuven

Status

Unknown

Conditions

Chronic Kidney Disease

Treatments

Behavioral: Standard care
Behavioral: Education by DVD and dietician
Behavioral: education by DVD

Study type

Interventional

Funder types

Other

Identifiers

NCT01509027
B322201112895

Details and patient eligibility

About

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.

Enrollment

150 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Health Services Research

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

150 participants in 3 patient groups, including a placebo group

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

Trial contacts and locations

0

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Central trial contact

Pieter Evenepoel, MD

Data sourced from clinicaltrials.gov

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