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

Primary Purpose

Chronic Kidney Disease

Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
education by DVD
Standard care
Education by DVD and dietician
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Chronic Kidney Disease focused on measuring hemodialysis, hyperphoshatemia, compliance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University Hospitals LeuvenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Education by DVD and dietician

Education by unpersonalised DVD

Standard Care

Arm Description

Information on detrimental conseqences of hyperphosphatemia is presented on DVD and individual dietary counseling is given by dieticican

Information on detrimental consequences of hyperphosphatemia is presented on DVD

standard care

Outcomes

Primary Outcome Measures

compliance
impact of education (by DVD and interview with dietician)on compliance with phosphorus restricted diet and phosphate binder therapy
serum phosphate levels
impact of education (by DVD and interview with dietician) on serum phosphate levels

Secondary Outcome Measures

risk factors of noncompliance
identification of risk factors for non compliance with emphasis on cognitive function and depression

Full Information

First Posted
January 9, 2012
Last Updated
May 29, 2012
Sponsor
Universitaire Ziekenhuizen KU Leuven
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1. Study Identification

Unique Protocol Identification Number
NCT01509027
Brief Title
Study of the Compliance With Phosphorus Restricted Diet and Phosphate Binder Therapy in Hemodialysis Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
June 2012 (Anticipated)
Study Completion Date
June 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
Keywords
hemodialysis, hyperphoshatemia, compliance

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Education by DVD and dietician
Arm Type
Active Comparator
Arm Description
Information on detrimental conseqences of hyperphosphatemia is presented on DVD and individual dietary counseling is given by dieticican
Arm Title
Education by unpersonalised DVD
Arm Type
Active Comparator
Arm Description
Information on detrimental consequences of hyperphosphatemia is presented on DVD
Arm Title
Standard Care
Arm Type
Placebo Comparator
Arm Description
standard care
Intervention Type
Behavioral
Intervention Name(s)
education by DVD
Intervention Description
Information on detrimental conseqences of hyperphosphatemia is presented on DVD
Intervention Type
Behavioral
Intervention Name(s)
Standard care
Intervention Description
standard care
Intervention Type
Behavioral
Intervention Name(s)
Education by DVD and dietician
Intervention Description
Information on detrimental conseqences of hyperphosphatemia is presented on DVD and individual dietary counseling is given by dieticican
Primary Outcome Measure Information:
Title
compliance
Description
impact of education (by DVD and interview with dietician)on compliance with phosphorus restricted diet and phosphate binder therapy
Time Frame
baseline and after intervention
Title
serum phosphate levels
Description
impact of education (by DVD and interview with dietician) on serum phosphate levels
Time Frame
baseline and after intervention
Secondary Outcome Measure Information:
Title
risk factors of noncompliance
Description
identification of risk factors for non compliance with emphasis on cognitive function and depression
Time Frame
baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pieter Evenepoel, MD
Phone
003216344580
Email
pieter.evenepoel@uz.kuleuven.ac.be
Facility Information:
Facility Name
University Hospitals Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pieter Evenepoel
First Name & Middle Initial & Last Name & Degree
Fabienne Dobbels

12. IPD Sharing Statement

Learn more about this trial

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

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