An interventional study of mHealth App in Dialysis Related Complication, sponsored by Hospital Universitari de Bellvitge. Active, not recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-22.
Sponsored by Hospital Universitari de Bellvitge · Not applicable, Interventional, and Prevention
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).
The working hypotheses are listed as follows:
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:
173 studies on the registry are indexed under Hyperphosphatemia; 16 are open to participants now.
This study's enrollment of 50 is below the median of 101 across 143 interventional studies indexed under Hyperphosphatemia.
Browse Hyperphosphatemia studies →Hospital Universitari de Bellvitge is the lead sponsor of 120 studies on the registry; 29 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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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 will be followed with the developed mobile web app,
Device: mHealth App
Patients will be treated according to the current clinical practice.
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.
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.
Time frame: 6-months follow-up
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.
Time frame: 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).
Time frame: 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).
Time frame: 6-months follow-up
Plan to share: Yes — Reporting the study design
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: 3 months
Access criteria: Publication
This study is active, not recruiting, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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