Pilot Study to Evaluate the Feasibility, Adherence and Acceptance of the MiDiálisis Platform for Patients on PD (PUMA)

Aida Frías González

Status: Enrolling

Conditions: Peritoneal Dialysis (PD)

Treatments: Device: Smart band; Device: Smart scale; Device: Patients will install the app during the phase 2.; Device: Patients will connect the smartband.; Device: MiDialisis App; Device: Patients will connect the digital scale.

Study type: Interventional

Funder types: Other

Identifiers

NCT07326085

23/187

Details and patient eligibility

About

The main goal of this study is to assess whether a mobile phone app called MiDiálisis is practical, easy to use, and well-accepted. The app was developed by the Technical University of Madrid (UPM) and is designed to bring together the clinical data of people with chronic kidney disease who are on peritoneal dialysis. This way, both patients and doctors can access the information at any time.

Full description

This is a free smartphone app that collects information in three ways:

1. The patient will enter their blood pressure and ultrafiltration values.
2. They will receive a digital scale that sends their weight and body composition to the MiDiálisis app via Bluetooth.
3. They will receive a smartband that sends information about their heart rate, sleep pattern, and physical activity to the MiDiálisis app via Bluetooth.

Enrollment: 55 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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55 participants in 1 patient group

INTERVENTION

Experimental group

Description:

This group will recived the smart band, smart scale and the APP

Treatment:

Device: Patients will connect the digital scale.

Device: Patients will connect the smartband.

Device: MiDialisis App

Device: Patients will install the app during the phase 2.

Device: Smart scale

Device: Smart band