mHealth System for the Self-control of Hyperphosphatemia in Patients With CKD.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Analysis of the superiority of mobile-app and benchmarking versus standard of care in lowering serum phosphorus
研究概览
简要总结
The project aims to generate an mHealth environment in which CKD patients are empowered in terms of the self-management of their hyperphosphatemia pathology, while under medical supervision. Such environment will allow nephrologists to inform patients beyond their traditional point-of-care and will allow patients to provide feedback on their condition in a timely manner that benefits the CKD collective. In this way we delve in a technological area that has been argued that remains underutilized within nephrology (1) and that should be perceived as an opportunity for CKD (2). In our work, we will build from recent related efforts in the control of hyperphosphatemia (3).
详细描述
The working hypotheses are listed as follows:
- Hyperphosphatemia is an important problem in the CKD realm, but difficult to manage because patients are often not aware of its importance. In addition, current clinical practice does not allow nephrologists to evaluate the patient's real understanding of their recommendations.
- The patient could benefit from a smartphone-based interactive virtual assistant tool: an integrated personalized management system to achieve a form of participatory, personalized, predictive and preventive medicine in the specific domain of a pathology associated to CKD.
- The combination of a flexible information channel with an interactive data visualization tool on mobile devices can be a most intuitive way to communicate with the patient, particularly if it allows comparison with other patients in similar situation. Additionally, data visualization can assist nephrologists in the clinical management of patients.
Primary Objective:
1-Analysis of the superiority of a Medical Mobile Application for Patient Support to educate CKD patients on how to self-manage their phosphate levels versus standard of care in lowering serum phosphorus by assessing changes in serum phosphorus comparing baseline with 6-months follow-up.
Secondary Objectives:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- 否
入选标准
- •1- Eligible patients will be stage 4-5 CKD patients, including end-stage renal disease (ESRD) on dialysis, aged >18 with hyperphosphatemia (serum phosphorus concentration >1.94 mmol/L) and stable dose of phosphate binders for >1 month before screening.
排除标准
- •Patients with intact parathyroid hormone concentration >800 ng/l (88 pmol/l) or if parathyroidectomy will be planned or expected.
- •Patients with significant gastro-intestinal (GI) or hepatic disorders.
- •Patients with major GI surgery.
结局指标
主要结局
Analysis of the superiority of mobile-app and benchmarking versus standard of care in lowering serum phosphorus
时间窗: 6-months follow-up
Reduction of serum phosphorus by more than 0.5 mmol/L versus the standard of care testing.
次要结局
- Quality of life improvement(6-months follow-up)
- Adherence to phosphate binder's use and reduction in their use.(6-months follow-up)
- Patient's and healthcare professionals' satisfaction with mobile health app to ensure its usability and promote patient retention(6-months follow-up)
研究者
MIGUEL HUESO VAL
Principal Investigator; Staff member of Nephrology Department
Hospital Universitari de Bellvitge