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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Chronic Kidney Disease

Intervention / Treatment
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* Behavioral: education by DVD
* Behavioral: Standard care
* Behavioral: Education by DVD and dietician


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Education by DVD and dietician<br>Information on detrimental conseqences of hyperphosphatemia is presented on DVD and individual dietary counseling is given by dieticican | Behavioral: Education by DVD and dietician<br>* Information on detrimental conseqences of hyperphosphatemia is presented on DVD and individual dietary counseling is given by dieticican<br>|
| Active Comparator: Education by unpersonalised DVD<br>Information on detrimental consequences of hyperphosphatemia is presented on DVD | Behavioral: education by DVD<br>* Information on detrimental conseqences of hyperphosphatemia is presented on DVD<br>|
| Placebo Comparator: Standard Care<br>standard care | Behavioral: Standard care<br>* standard care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| compliance | impact of education (by DVD and interview with dietician)on compliance with phosphorus restricted diet and phosphate binder therapy | baseline and after intervention | 
| serum phosphate levels | impact of education (by DVD and interview with dietician) on serum phosphate levels | baseline and after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| risk factors of noncompliance | identification of risk factors for non compliance with emphasis on cognitive function and depression | baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hemodialysis, hyperphoshatemia, compliance