Clinical trial NCT05389826: mHealth for Phosphorus Management in CKD.
Official title: mHealth System for the Self-control of Hyperphosphatemia in Patients With CKD.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Dialysis Related Complication
Keywords: mHealth
Hyperphosphatemia
Lead sponsor: Hospital Universitari de Bellvitge
Sponsor class: OTHER
Collaborators: name: Vifor Pharma
First posted: 2022-05-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Analysis of the superiority of mobile-app and benchmarking versus standard of care in lowering serum phosphorus
timeFrame: 6-months follow-up
Secondary outcomes:
measure: Adherence to phosphate binder's use and reduction in their use.
timeFrame: 6-months follow-up
measure: Quality of life improvement
timeFrame: 6-months follow-up
measure: Patient's and healthcare professionals' satisfaction with mobile health app to ensure its usability and promote patient retention
timeFrame: 6-months follow-up
Other outcomes:
Locations:
city: L'Hospitalet de Llobregat
country: Spain
facility: Hospital Bellvitge
state: Barcelona
Study officials:
References:
citation: Stauss M, Dhaygude A, Ponnusamy A, Myers M, Woywodt A. Remote digital urinalysis with smartphone technology as part of remote management of glomerular disease during the SARS-CoV-2 virus pandemic: single-centre experience in 25 patients. Clin Kidney J. 2021 Dec 21;15(5):903-911. doi: 10.1093/ckj/sfab286. eCollection 2022 May.
citation: Topf JM, Hiremath S. Got CKD? There's an App for That! Clin J Am Soc Nephrol. 2019 Apr 5;14(4):491-492. doi: 10.2215/CJN.02350219. Epub 2019 Mar 21. No abstract available.
citation: Chiang YC, Chang YP, Lin SC, Lin C, Hsu PH, Hsu YJ, Wu TJ. Effects of Individualized Dietary Phosphate Control Program With a Smartphone Application in Hemodialysis Patients in Taiwan. Biol Res Nurs. 2021 Jul;23(3):375-381. doi: 10.1177/1099800420975504. Epub 2020 Nov 28.