MiDiálisis mobile app with Bluetooth scale and smartband for people on peritoneal dialysis
Pilot Study of MiDialisis App Usage (Estudio Piloto de Uso de MiDiálisis App)
This pilot will try a smartphone app plus a Bluetooth scale and smartband to help adults on peritoneal dialysis track weight, vitals, and activity and share the data with their care team.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 55 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital Universitario 12 de Octubre Academic / other |
| Locations | 1 site (Madrid, Madrid) |
| Trial ID | NCT07326085 on ClinicalTrials.gov |
What this trial studies
Researchers will pilot the MiDiálisis platform, a free smartphone app developed by the Technical University of Madrid, at Hospital 12 de Octubre. Adult patients on peritoneal dialysis who have been on PD for at least three months and who own a smartphone or tablet will install the app and connect a Bluetooth digital scale and a smartband. Patients will manually enter blood pressure and ultrafiltration values while the scale sends weight and body-composition data and the smartband transmits heart rate, sleep, and activity metrics to the app. The study will measure feasibility, adherence, and patient acceptance of the platform.
Who should consider this trial
Good fit: Adults (age ≥18) on chronic peritoneal dialysis for at least three months, clinically stable, who have a compatible smartphone or tablet, internet access, and can provide informed consent.
Not a fit: Patients without smartphone access or skills, those with pacemakers or implantable cardioverter-defibrillators (which preclude multifrequency body-composition measurement), those scheduled for imminent transplant, or with life expectancy under six months may not benefit.
Why it matters
Potential benefit: If successful, the platform could simplify home monitoring and help patients and clinicians detect problems earlier and communicate more easily.
How similar studies have performed: Other small studies of remote monitoring in dialysis populations have shown feasibility and improved patient engagement, but integrated smartphone platforms like MiDiálisis remain relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients over 18 years of age. * Patients with chronic kidney disease who have been on PD for at least 3 months in the same hospital. * Patients with a stable clinical condition during the 3 months prior to entering the study, defined as no unscheduled hospitalizations or major cardiovascular events (myocardial infarction or stroke) during that period. * Availability of a smartphone or tablet and internet access for the patient/caregiver. * Patients who understand the nature of the study and sign the informed consent form. Exclusion Criteria: * Patients with limitations for multifrequency body composition measurement (pacemaker or implantable cardioverter defibrillator wearers, and pregnant women). * Patients who do not routinely use a smartphone or are unfamiliar with the use of mobile applications. * Patients who are scheduled for a living kidney transplant in the next 6 months. * Patients with a life expectancy of less than 6 months. * Patients in a peritoneal ultrafiltration program due to cardiorenal syndrome.
Where this trial is running
Madrid, Madrid
- Hospital 12 de Octubre — Madrid, Madrid, Spain (Recruiting)
Study contacts
- Principal investigator: Claudia Yuste Lozano, PhD — Hospital 12 de Octubre
- Study coordinator: Aida Frias, MD
- Email: midialisispuma@gmail.com
- Phone: +34667805030
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.