We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2012 by Universitaire Ziekenhuizen Leuven.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01509027
First Posted: January 12, 2012
Last Update Posted: May 30, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven
  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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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:


Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome 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 Outcome Measures:
  • risk factors of noncompliance [ Time Frame: baseline ]
    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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01509027     History of Changes
Other Study ID Numbers: B322201112895
First Submitted: January 9, 2012
First Posted: January 12, 2012
Last Update Posted: May 30, 2012
Last Verified: January 2012

Keywords provided by Universitaire Ziekenhuizen Leuven:
hemodialysis
hyperphoshatemia
compliance

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