Dialysis Related Complication Clinical Trial
— PHOSFO_OKOfficial title:
mHealth System for the Self-control of Hyperphosphatemia in Patients With CKD.
Verified date | September 2023 |
Source | Hospital Universitari de Bellvitge |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Active, not recruiting |
Enrollment | 50 |
Est. completion date | October 15, 2023 |
Est. primary completion date | October 15, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Bellvitge | L'Hospitalet de Llobregat | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Hospital Universitari de Bellvitge | Vifor Pharma |
Spain,
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. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 |
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