Behavioral Management of Phosphorus in Hemodialysis

 说明(申请人提供)：磷不能通过透析法充分去除，必须通过饮食限制和磷酸盐粘合剂的摄入量相结合来控制。高磷血症在血液透析患者中很常见，似乎是导致这一人群心血管发病率和死亡率的关键因素。这项两阶段研究的目的是提供概念证明，并描述行为干预的可行性和可接受性，以促使血液透析患者进行多种行为改变，以适当地管理高磷血症，包括坚持磷酸盐结合和减少饮食中的磷，同时确保足够的蛋白质摄入量。在第一阶段，参与者将被随机分配到三个为期12周的计划中的一个：(第1组)单独教育，(第2组)教育+移动设备饮食自我监测和反馈；或(第3组)教育+移动设备饮食自我监测和反馈结合基于社会认知理论的咨询。第二阶段将是观察阶段，没有进一步的干预接触，但允许第二组和第三组的参与者保留技术，并鼓励他们继续自我监测。我们将主要从行为变化(对粘合剂的依从性和饮食摄入量)、血清磷和标准化蛋白质分解代谢率方面对研究人员进行比较。我们将描述自我效能感的中介作用。

 DESCRIPTION (provided by applicant): Phosphorus is not adequately removed by dialysis, and must be controlled by a combination of dietary restriction and intake of phosphate binders. Hyperphosphatemia is common in hemodialysis patients and appears to be a key contributing factor to cardiovascular morbidity and mortality in this population. The purpose of this 2-phase study is to provide proof of concept and describe feasibility and acceptability of a behavioral intervention to engage hemodialysis patients in multiple behavior changes to properly manage hyperphosphatemia, including adherence to phosphate binders and reduction of dietary phosphorus while assuring adequate protein intake. In Phase 1, participants will be randomized, using equal allocation, to one of three 12-week programs: (Group 1) education alone, (Group 2) education plus mobile device dietary self- monitoring and feedback; or (Group 3) education plus mobile device dietary self-monitoring and feedback combined with Social Cognitive Theory-based counseling. Phase 2 will be an observation phase with no further intervention contact, although participants in Groups 2 and 3 are permitted to retain the technology and encouraged to continue self-monitoring. We will compare the study arms, primarily, in terms of behavior changes (adherence to binders and dietary intake), serum phosphorus, and normalized protein catabolic rate. We will describe the mediating effect of self-efficacy.