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临床试验/NCT00136253
NCT00136253已完成不适用

Overcoming Nutritional Barriers in Hemodialysis Patients

Case Western Reserve University0 个研究点开始时间: 2002年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
主要终点
Change in albumin

研究概览

简要总结

American hemodialysis patients are frequently malnourished. This contributes to dialysis patient mortality rates that are the highest in the industrialized world at 22% per year. Poor nutritional status probably also contributes to high health care costs (an average of two hospitalizations annually per patient and total Medicare expenditures of $11 billion per year) and diminished quality of life. The researchers' prior work identified several potentially modifiable nutritional barriers (e.g. poor appetite, inadequate dialysis dose, poor nutritional knowledge, low fluid intake, and needing help shopping and cooking) and pilot tested a promising approach to overcome these barriers.

This proposed community-based randomized controlled trial extends the researchers' prior work by targeting specific nutritional barriers with a tailored feedback and education intervention. Approximately 40 dialysis facilities in northeast Ohio will be randomly assigned to intervention and control groups, with approximately 100 malnourished patients enrolled from 20 intervention facilities and 100 from 20 control facilities. Baseline evaluation will include measures of nutritional status, specific barriers, inpatient expenditures, and quality of life. On a monthly basis for 12 months, intervention patients and their dietitians will receive tailored feedback and education on overcoming patient-specific barriers. They will then meet monthly to jointly formulate a care plan addressing these barriers. Control patients will continue to get usual care. Major analyses will compare changes in nutritional parameters in intervention vs. control patients with adjustment for nesting of patients within facilities.

The proposed project will test a novel intervention that targets patients and providers as they together make nutrition-related decisions. Overcoming specific barriers may lead not only to improved nutritional status but also to better patient survival, decreased health care costs, and increased quality of life.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
None

入排标准

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

入选标准

  • Most recent albumin and mean albumin over last 3 months <3.7 g/dL by bromcresol green method (or <3.4 g/dL by bromcresol purple method)
  • Age greater than or equal to 18 years
  • On chronic hemodialysis at least 9 months

排除标准

  • Mentally incompetent
  • Cirrhosis
  • Terminal illness
  • Malabsorption
  • Receiving total parenteral nutrition

结局指标

主要结局

Change in albumin

Change in albumin of 0.20 or greater and survival

次要结局

  • Change in subjective global assessment, weight, dietary intake, specific nutritional barriers

研究者

申办方类型
Other

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