Health TrialsbyHealthPanel

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

ConditionPeritoneal Dialysis (PD)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAida Frías González

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • Smart band

    Device

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

  • Smart scale

    Device

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

  • MiDialisis App

    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.

    Device

    Patients will download and begin using the application.

  • Patients will connect the digital scale.

    Device

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

  • Patients will connect the smartband.

    Device

    Patients will connect the smartband to the application via Bluetooth.

Treatment groups

55 Participants
are divided into 1 treatment group
Group A: INTERVENTIONExperimental treatment 6 interventions

Trial outcomes

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.

Time frame
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

1

Perceived quality

To assess patient and caregiver satisfaction (perceived quality, visit 4) with the use of MiDiálisis, measured using the Mobile App Rating Scale (MARS), (23 items, max. 115 points, higher scores mean a better outcome).

Time frame
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.
2

Usability

To assess healthcare professionals' satisfaction with the use of the MiDiálisis dashboard. the healthcare professional will filled the System Usability Scale (SUS) (10 items, max 50 points, higher scores mean a better outcome).

Time frame
After 8 weeks using MiDialisis dashboard (week +16 from recruitment, visit 4).
3

In-person Clinical care

Changes in in-person clinical care, measured as the number of face-to-face visits across Phase 1, Phase 2, and Phase 3.

Time frame
At the end of the study (week +24 from recruitment, visit 5).
4

telephone-based clinical care

Changes in telephone-based clinical care, measured as differences in the number of telephone calls across Phase 1, Phase 2, and Phase 3.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Aida Frías González

Lead sponsor

Hospital Universitario 12 de Octubre

Sponsor institution

Spanish Society of Nephrology

Collaborator

SOMANE (MADRID SOCIETY OF NEPHROLOGY)

Collaborator

Foundation for Biomedical Research of the Hospital Universitario 12 de Octubre

Collaborator

Source ClinicalTrials.gov
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