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

Universitaire Ziekenhuizen KU Leuven

Status: Unknown

Conditions: Chronic Kidney Disease

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

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

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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