跳至主要内容
临床试验/NCT07080840
NCT07080840Enrolling By Invitation不适用

Adherence as a Moderator of Phosphorus Education Effectiveness in Hemodialysis Patients: an Exploratory Study

Jen-Ai Hospital Institutional Review Board2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2024年7月29日最近更新:

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
45
试验地点
2
主要终点
phosphate

研究概览

简要总结

By applying statistical methods such as analysis of variance (ANOVA), this study incorporates both the content and the intensity (frequency) of educational interventions to design multiple regression models for evaluating education strategies. Through each round of laboratory data, the investigators aim to identify the most effective educational model using empirical data. The findings will not only improve phosphorus management and enhance the quality of care but also reduce unnecessary nursing workload and help establish an optimal educational protocol and training framework.

Based on literature review and clinical experience, it is well recognized that, in addition to receiving regular and adequate dialysis, effective phosphorus control relies heavily on patients' daily dietary selection and the appropriate use and frequency of phosphate binders. Hence, this study aims to investigate the correlation between phosphorus control and patient education delivered by nursing staff, focusing on dietary management, phosphate binder usage, and knowledge of dialysis principles.

By applying statistical methods such as analysis of variance (ANOVA), this study incorporates both the content and the intensity (frequency) of educational interventions to design multiple regression models for evaluating education strategies. Through each round of laboratory data, we aim to identify the most effective educational model using empirical data. The findings will not only improve phosphorus management and enhance the quality of care but also reduce unnecessary nursing workload and help establish an optimal educational protocol and training framework.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients who have been on dialysis for more than one year, have intact self-awareness, and are currently taking phosphate-binding medications.

排除标准

  • Patients who have been on dialysis for less than one year, lack self-awareness, or are not taking phosphate-lowering medications.

结局指标

主要结局

phosphate

时间窗: Baseline and every 2 weeks until Week 12 (August 19 to November 4, 2025)

Serum phosphorus levels were measured every two weeks during the 12-week intervention period. Blood samples were collected on Monday or Tuesday, aligned with the patient's hemodialysis cycle (W123 or W246), beginning August 19 and ending November 4, 2025. A total of 6 blood draws were performed. All samples were taken pre-dialysis via venipuncture, with each draw limited to 20 mL and total sample volume not exceeding 320 mL over the study period. it is expedited review according to Take blood samples from fingers, heels, ears, or veins of an adult weighing more than 50 kg. Also, the total amount of sample collection should not be more than 320 ml in 8 weeks and should not be more than twice a week. The amount of each blood collection should not be more than 20 ml.

次要结局

未报告次要终点

研究者

发起方
Jen-Ai Hospital Institutional Review Board
申办方类型
Industry
责任方
Principal Investigator
主要研究者

Ming-Chih Chang

Jen-Ai Hospital Principal Investigator

Jen-Ai Hospital Institutional Review Board

研究点 (2)

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