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临床试验/NCT01509027
NCT01509027Unknown不适用

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

Universitaire Ziekenhuizen KU Leuven1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2012年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
150
试验地点
1
主要终点
compliance

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •prevalent (>3months) hemodialysis patients
  • •aged > 18 years
  • •informed consent

排除标准

  • •decreased consciousness
  • •medical contraindication for phosphorus restricted diet or phsophate binder therapy

研究组 & 干预措施

Education by DVD and dietician

Active Comparator

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

干预措施: Education by DVD and dietician (Behavioral)

Education by unpersonalised DVD

Active Comparator

Information on detrimental consequences of hyperphosphatemia is presented on DVD

干预措施: education by DVD (Behavioral)

Standard Care

Placebo Comparator

standard care

干预措施: Standard care (Behavioral)

结局指标

主要结局

compliance

时间窗: 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

时间窗: baseline and after intervention

impact of education (by DVD and interview with dietician) on serum phosphate levels

次要结局

  • risk factors of noncompliance(baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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