NCT05389826

mHealth for Phosphorus Management in CKD.

mHealth System for the Self-control of Hyperphosphatemia in Patients With CKD.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Hospital Universitari de Bellvitge · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

The working hypotheses are listed as follows: 1. 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. 2. 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. 3. 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: 1. Adherence to treatment with phosphate binders. 2. Impact in Quality of Life of patients with CKD. 3. Satisfaction of such a tool.

Conditions

• Dialysis Related Complication

Interventions

Type	Name	Description
DEVICE	mHealth App	We will compare the degree of improvement in phosphate control with respect to baseline values and report any adverse event. Nephrologist will use a web management system to provide results of phosphorus levels and medical recommendations to the patient, mediated by a cloud IT environment. In addition, patients will receive alerts, suggestions, and general information. They will also be able to communicate with nephrologists and interact with their corresponding group of fellow patients.

Timeline

• Start date: 2022-06-01
• Primary completion: 2023-10-15
• Completion: 2023-10-15
• First posted: 2022-05-25
• Last updated: 2023-09-22

Locations

1 site across 1 country: Spain