mHealth for Phosphorus Management in CKD.

NCT05389826 | Unknown

• 1 other identifier: PR291/21
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

Dialysis Related Complication

Keywords

mHealth; Hyperphosphatemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Adherence to phosphate binder's use and reduction in their use.

  6-months follow-up

• Quality of life improvement

  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

Study Arms (2)

mHealth App group

EXPERIMENTAL

Patients will be followed with the developed mobile web app,

Device: mHealth App

Control

NO INTERVENTION

Patients will be treated according to the current clinical practice.

Interventions

mHealth App DEVICE

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.

mHealth App group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitari de Bellvitge: lead
• Vifor Pharma: collaborator

Study Sites (1)

Hospital Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Related Publications (3)

• 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.

  PMID: 35498887 BACKGROUND

• 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.

  PMID: 30898874 BACKGROUND

• 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.

  PMID: 33251815 BACKGROUND

MeSH Terms

Conditions

Hyperphosphatemia

Condition Hierarchy (Ancestors)

Phosphorus Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator; Staff member of Nephrology Department

Model Details: 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.

Study Record Dates

• First Submitted: May 13, 2022
• First Posted: May 25, 2022
• Study Start: June 1, 2022
• Primary Completion: October 15, 2023
• Study Completion: October 15, 2023
• Last Updated: September 22, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 3 months
• Access Criteria: Publication

Locations

ES (1)