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

NCT ID: NCT07326085

Last Updated: 2026-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-27

Study Completion Date

2026-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Peritoneal Dialysis (PD)

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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INTERVENTION

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

Group Type EXPERIMENTAL

Patients will connect the smartband.

Intervention Type DEVICE

Patients will connect the smartband to the application via Bluetooth.

Smart band

Intervention Type DEVICE

During Phase 2, patients will use the smart band continuously throughout the day.

Smart scale

Intervention Type DEVICE

During Phase 2, patients will weigh themselves daily using the scale.

MiDialisis App

Intervention Type DEVICE

Patients will enter daily blood pressure data and information related to their peritoneal dialysis therapy.

Patients will install the app during the phase 2.

Intervention Type DEVICE

Patients will download and begin using the application.

Patients will connect the digital scale.

Intervention Type DEVICE

Patients will connect the digital scale to the application via Bluetooth.

Interventions

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Patients will connect the smartband.

Patients will connect the smartband to the application via Bluetooth.

Intervention Type DEVICE

Smart band

During Phase 2, patients will use the smart band continuously throughout the day.

Intervention Type DEVICE

Smart scale

During Phase 2, patients will weigh themselves daily using the scale.

Intervention Type DEVICE

MiDialisis App

Patients will enter daily blood pressure data and information related to their peritoneal dialysis therapy.

Intervention Type DEVICE

Patients will install the app during the phase 2.

Patients will download and begin using the application.

Intervention Type DEVICE

Patients will connect the digital scale.

Patients will connect the digital scale to the application via Bluetooth.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Spanish Society of Nephrology

OTHER

Sponsor Role collaborator

SOMANE (MADRID SOCIETY OF NEPHROLOGY)

UNKNOWN

Sponsor Role collaborator

Foundation for Biomedical Research of the Hospital Universitario 12 de Octubre

UNKNOWN

Sponsor Role collaborator

Aida Frías González

OTHER

Sponsor Role lead

Responsible Party

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Aida Frías González

M.D., Nephrologist at Universitary Hospital 12 de Octubre

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Claudia Yuste Lozano, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital 12 de Octubre

Locations

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Hospital 12 de Octubre

Madrid, Madrid, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Aida Frias, MD

Role: CONTACT

+34667805030

Paula Jara Caro Espada, MD

Role: CONTACT

+34646403845

Facility Contacts

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Jara Caro Espada, MD

Role: primary

+34646403845

Claudia Yuste Lozano, PhD

Role: backup

+34619410963

Other Identifiers

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23/187

Identifier Type: -

Identifier Source: org_study_id

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