NCT07326085

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
7mo left

Started Jul 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress58%
Jul 2025Nov 2026

Study Start

First participant enrolled

July 27, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 1, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 8, 2026

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 24, 2026

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2026

Expected
Last Updated

January 8, 2026

Status Verified

December 1, 2025

Enrollment Period

6 months

First QC Date

December 1, 2025

Last Update Submit

January 3, 2026

Conditions

Peritoneal Dialysis (PD)

Keywords

peritoneal dialysysremote monitoring

Outcome Measures

Primary Outcomes (1)

  • Feasibility and adherence

    To assess the feasibility and adherence to the use of MiDiálisis among patients undergoing peritoneal dialysis (PD), defined as the number of times per week that the patient or caregiver accesses the MiDiálisis app.

    The investigators analized the number of times that patient or caregiver access the MiDialisis app during 8 weeks that the patient would be installed the App in his mobile.

Secondary Outcomes (10)

  • Perceived quality

    After 8 weeks of using mobile App (week +16 from recruitment), the patient or caregiver will filled Mobile App Rating Scale (MARS) to analized satisfaction grade.

  • Usability

    After 8 weeks using MiDialisis dashboard (week +16 from recruitment, visit 4).

  • In-person Clinical care

    At the end of the study (week +24 from recruitment, visit 5).

  • telephone-based clinical care

    At the end of the study (week +24 from recruitment, visit 5).

  • unscheduled visits

    At the end of the study (week +24 from recruitment, visit 5).

  • +5 more secondary outcomes

Study Arms (1)

INTERVENTION

EXPERIMENTAL

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

Device: Smart bandDevice: Smart scaleDevice: MiDialisis AppDevice: Patients will install the app during the phase 2.Device: Patients will connect the digital scale.Device: Patients will connect the smartband.

Interventions

Smart bandDEVICE

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

INTERVENTION
Smart scaleDEVICE

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

INTERVENTION
MiDialisis AppDEVICE

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

INTERVENTION
Patients will install the app during the phase 2.DEVICE

Patients will download and begin using the application.

INTERVENTION
Patients will connect the digital scale.DEVICE

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

INTERVENTION
Patients will connect the smartband.DEVICE

Patients will connect the smartband to the application via Bluetooth.

INTERVENTION

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital 12 de Octubre

Madrid, Madrid, 28041, Spain

RECRUITING

Study Officials

  • Claudia Yuste Lozano, PhD

    Hospital 12 de Octubre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Aida Frias, MD

CONTACT

+34667805030midialisispuma@gmail.com

Paula Jara Caro Espada, MD

CONTACT

+34646403845jcaroespada@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
M.D., Nephrologist at Universitary Hospital 12 de Octubre

Study Record Dates

First Submitted

December 1, 2025

First Posted

January 8, 2026

Study Start

July 27, 2025

Primary Completion

January 24, 2026

Study Completion (Estimated)

November 30, 2026

Last Updated

January 8, 2026

Record last verified: 2025-12

Locations

ES(1)