mHealth for Phosphorus Management in CKD.

Not Applicable

Active, not recruiting

• Conditions: Dialysis Related Complication
• Interventions: Device: mHealth App

• Registration Number: NCT05389826
• Lead Sponsor: Hospital Universitari de Bellvitge

Brief 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.

Study Timeline

• Study First Submitted: 2022-05-13
• Study First Submitted QC: 2022-05-21
• Study First Posted: 2022-05-25
• Study Start: 2022-06-01
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-20
• Last Update Posted: 2023-09-22
• Primary Completion: 2023-10-15
• Study Completion: 2023-10-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 50

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

1. Patients with intact parathyroid hormone concentration >800 ng/l (88 pmol/l) or if parathyroidectomy will be planned or expected.
2. Patients with significant gastro-intestinal (GI) or hepatic disorders.
3. Patients with major GI surgery.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mHealth App group	mHealth App	Patients will be followed with the developed mobile web app,

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital Bellvitge; 🇪🇸 L'Hospitalet de Llobregat, Barcelona, Spain