Study of the Compliance With Phosphorus Restricted Diet and Phosphate Binder Therapy in Hemodialysis Patients
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
1 other identifier
interventional
150
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2012
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
January 9, 2012
CompletedFirst Posted
Study publicly available on registry
January 12, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedMay 30, 2012
January 1, 2012
5 months
January 9, 2012
May 29, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
risk factors of noncompliance
baseline
Study Arms (3)
Education by DVD and dietician
ACTIVE COMPARATORInformation on detrimental conseqences of hyperphosphatemia is presented on DVD and individual dietary counseling is given by dieticican
Education by unpersonalised DVD
ACTIVE COMPARATORInformation on detrimental consequences of hyperphosphatemia is presented on DVD
Standard Care
PLACEBO COMPARATORstandard care
Interventions
Information on detrimental conseqences of hyperphosphatemia is presented on DVD
Information on detrimental conseqences of hyperphosphatemia is presented on DVD and individual dietary counseling is given by dieticican
Eligibility Criteria
You may qualify if:
- prevalent (\>3months) hemodialysis patients
- aged \> 18 years
- informed consent
You may not qualify if:
- decreased consciousness
- unstable
- medical contraindication for phosphorus restricted diet or phsophate binder therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospitals Leuven
Leuven, 3000, Belgium
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 9, 2012
First Posted
January 12, 2012
Study Start
January 1, 2012
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
May 30, 2012
Record last verified: 2012-01