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临床试验/NCT00394576
NCT00394576已完成不适用

Assessing Novel Methods of Improving Patient Education of Nutrition: eHealth, Health Literacy and Chronic Kidney Disease

University of Wisconsin, Madison2 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2006年11月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
54
试验地点
2
主要终点
Compliance with dietary phosphorous will be measured by serum calcium phosphorus product.

研究概览

简要总结

The relationship between elevated phosphorus levels and morbidity and mortality in patients with chronic kidney disease (CKD) is well recognized, and dietary phosphorus restriction is a mainstay of phosphate management. Current study is an effort to test the effect of a web-based nutritional educational intervention, Kidney School(KS), to improve phosphorous knowledge and control phosphorous intake in CKD patients.

详细描述

The relationship between elevated phosphorous level in the severity of Chronic kidney disease(CKD) is well documented. However, appropriate control of phosphate intake remains sub-par, due in part to the difficulties that patients have understanding phosphate content in foods.

Randomized trials have shown that intensive, individualized dietary counseling can improve patient knowledge about phosphorus and help control hyperphosphatemia; however, maintaining this level of counseling is time-consuming, costly, and impractical. Given the recognized nephrology workforce shortage, there is a crucial need for systems to fill this gap with novel technologies to educate patients, and it is vital that a better understanding of the effects of novel nutritional intervention counseling methods on patient knowledge, nutritional intake and nutritional status be evaluated in CKD patients.

Furthermore, to effectively engage in the patient side of the education process, those who receive it, the patients, must be able to comprehend information and draw on it for decision-making. Novel educational interventions may be better suited than traditional methods to circumvent literacy limitations. Therefore, it is vital to assess the relation of functional health literacy of this population in both traditional and emerging educational venues.

Kidney School (KS, http://www.kidneyschool.org) is an online, personalized, interactive self-management learning center created by the Madison, WI based Medical Education Institute (MEI) and organized into fifteen 20-30 minute modules, each focused on a different topic related to kidney disease and its treatment, including nutrition. Content is based on 10 years of research conducted by the Life Options Rehabilitation Program, with internal and external expert review. The nutrition module is tailored for patients with or without diabetes.

The importance of phosphorus control for patients with CKD has traditionally been vital to prevent bone disease. More recently it is recognized that poor phosphorus control correlates with cardiovascular disease, of which patients with CKD carry an enormous burden. Similarly, there has recently been much attention to circulating endothelial cells (CECs) as a novel marker for cardiovascular risk in this population. While the ultimate test would be to determine if controlling phosphorus impacts on cardiovascular events, that is beyond the scope of this project. Therefore, we propose to measure levels of CECs as an intermediary step toward cardiovascular events, in correlation to phosphorus intake.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age greater than or equal to 18 and less than 90
  • Chronic kidney disease stage 3, 4 or 5
  • Adequate visual acuity with correction to allow discrimination of 14-point type
  • Ability to read English
  • Ability to provide informed consent

排除标准

  • Anticipated need for renal replacement therapy within 60 days
  • Prison population

研究组 & 干预措施

usual care plus Internet-based nutrition module

Experimental

usual care plus Internet-based nutrition module

干预措施: Internet-based nutrition module along with usual care (Behavioral)

usual care

Active Comparator

usual care

干预措施: usual care (Behavioral)

结局指标

主要结局

Compliance with dietary phosphorous will be measured by serum calcium phosphorus product.

时间窗: 4 to 8 weeks after initial questionnaire/survey appointment

Measurement of compliance with dietary phosphorous will be measured by serum calcium phosphorus product.

Compliance with dietary phosphorous will be measured by serum calcium level

时间窗: 4 to 8 weeks after initial questionaire/survey appointment

Measurement of compliance with dietary phosphorous will be measured by serum calcium level. In CKD, calcium is not reabsorbed, leading to decreased serum calcium.

Gain in phosphorus knowledge as assessed by the chronic kidney disease Knowledge Assessment Tool (CKDKAT) of nutrition.

时间窗: 4 to 8 weeks post intial questionnaire/survey

The CKDKAT of nutrition is a revised version of the original CKDKAT, which addresses only nutritional knowledge specific to chronic kidney disease (CKD). 15 of 25 questions are phosphorus-specific, with the remaining 10 concerning sodium, potassium and protein intake.

Compliance with dietary phosphorus intake will be measured by using 24 hour recall diary.

时间窗: 4 to 8 weeks after initial questionnaire/survey appointment

For measuring compliance with dietary phosphorus intake, data will be collected by 24 hour recall diaries. Nutrient analysis data will be analyzed by Food Processor SQL Nutrition Software (ESHA Research, Salem, Oregon)

Compliance with dietary phosphorous will be measured by serum phosphorous level.

时间窗: 4 to 8 weeks after initial questionnaire/survey appointment

Measurement of compliance with dietary phosphorous will be measured by serum phosphorous level. In CKD, Phosphorus excretion diminishes, leading to an increase in serum phosphorus levels.

Compliance with dietary phosphorous will be measured by para thyroid hormone (PTH) level

时间窗: 4 to 8 weeks after initial questionnaire/survey appointment

Measurement of compliance with dietary phosphorous will be measured by para thyroid hormone (PTH) level. In CKD, Both decreased serum calcium levels and increased serum phosphorus levels stimulate excessive secretion of PTH.

次要结局

  • Correlations between dietary phosphorus intake, serum phosphorous levels and circulating endothelial cells (CECs) in CKD(2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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