mHealth for Phosphorus Management in CKD.

Study Overview
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Brief Summary
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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
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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: Adherence to treatment with phosphate binders. Impact in Quality of Life of patients with CKD. Satisfaction of such a tool.

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

Conditions
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Dialysis Related Complication

Intervention / Treatment
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* Device: mHealth App


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Pilot study involving cases and controls. Fifty outpatient patients with stage 4-5 CKD, including those on dialysis will be included. Twenty-five patients will be followed with the developed mobile web app, while another twenty-five patients will be treated according to the current clinical practice. Patients will be randomized blindly 1:1 to the study group or to the control group. The randomization technique consists of consecutively numbered sealed envelopes on which the signed group is written.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mHealth App group<br>Patients will be followed with the developed mobile web app, | Device: mHealth App<br>* 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.<br>|
| No Intervention: Control<br>Patients will be treated according to the current clinical practice. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of the superiority of mobile-app and benchmarking versus standard of care in lowering serum phosphorus | Reduction of serum phosphorus by more than 0.5 mmol/L versus the standard of care testing. | 6-months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to phosphate binder's use and reduction in their use. | The ratio of current phosphate binders that the patient is swallowing compared to the number prescribed. | 6-months follow-up | 
| Quality of life improvement | Health-related quality of life (HRQoL) will be assessed with the Short-Form 12 questionnaire (SF-12). | 6-months follow-up | 
| Patient's and healthcare professionals' satisfaction with mobile health app to ensure its usability and promote patient retention | Satisfaction of patients will be assessed with the quality of care satisfaction in outpatient consultation questionnaire (EQS-C). | 6-months follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mHealth, Hyperphosphatemia