Peritoneal Dialysis (PD)PUMANCT07326085
Pilot Study to Evaluate the Feasibility, Adherence and Acceptance of the MiDiálisis Platform for Patients on PD
A study testing Smart band, Smart scale and MiDialisis App in people with Peritoneal Dialysis (PD), run by Aida Frías González at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peritoneal Dialysis (PD)
- What is being tested?
- Smart band, Smart scale and MiDialisis App
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteSpain
- Study dates
- 27 Jul 2025to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital 12 de Octubre
Madrid, Madrid, 28041
Jara Caro Espada, MD, +34646403845, jcaroespada@gmail.com
Claudia Yuste Lozano, PhD, +34619410963, claudia.yuste@salud.madrid.org
About this study
Official title: Pilot Study of MiDialisis App Usage (Estudio Piloto de Uso de MiDiálisis App)
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.
Read the detailed description
This is a free smartphone app that collects information in three ways:
- The patient will enter their blood pressure and ultrafiltration values.
- They will receive a digital scale that sends their weight and body composition to the MiDiálisis app via Bluetooth.
- They will receive a smartband that sends information about their heart rate, sleep pattern, and physical activity to the MiDiálisis app via Bluetooth.
- Conditions
- Peritoneal Dialysis (PD)
- Being tested
- Smart band, Smart scale, MiDialisis App, Patients will install the app during the phase 2., Patients will connect the digital scale.
- Keywords
- peritoneal dialysys, remote monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smart bandDevice
During Phase 2, patients will use the smart band continuously throughout the day.
Smart scaleDevice
During Phase 2, patients will weigh themselves daily using the scale.
MiDialisis AppDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| INTERVENTION | Experimental | This group will recived the smart band, smart scale and the APP Receives: Device: Smart band; Device: Smart scale; Device: MiDialisis App; Device: Patients will install the app during the phase 2.; Device: Patients will connect the digital scale.; Device: Patients will connect the smartband. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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).
Measured: 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
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).
Measured: After 8 weeks using MiDialisis dashboard (week +16 from recruitment, visit 4).
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.
Measured: At the end of the study (week +24 from recruitment, visit 5).
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.
Measured: At the end of the study (week +24 from recruitment, visit 5).
unscheduled visits
Changes in the number of unscheduled visits.Measured as the number of unscheduled visits between Phase 1, Phase 2, and Phase 3.
Measured: At the end of the study (week +24 from recruitment, visit 5).
overall clinical care
Changes in overall clinical care. Measured as the number of interactions in the MiDiálisis chat vs. another objetives.
Measured: At the end of the study (week +24 from recruitment, visit 5).
Kidney Disease Quality of Life-36
Changes in patient-reported health outcomes (PROMs) with MiDiálisis between Phase 1 and Phase 2.
Measured using the Kidney Disease Quality of Life-36 (KDQOL-36) scale (36 items, max 100 points, higher scores mean a better outcome.).
Measured: At the end of the study (week +24 from recruitment, visit 5).
Kidney Disease and Quality of Life™ Short Form
Changes in patient-reported health experience (PREMS) with the use of MiDiálisis between Phase 1 and Phase 2.
Measured with the Kidney Disease and Quality of Life™ Short Form (KDQOLSF) (24 items, quantitative, higher scores mean a better outcome).
Measured: At the end of the study (week +24 from recruitment, visit 5).
Pittsburgh Sleep Quality Index
Assess subjective changes in sleep quality between Phase 1 and Phase 2. Measured using the Pittsburgh Sleep Quality Index (PSQI) (19 items, max 21 points, higher scores mean a worse outcome).
Measured: At the end of the study (week +24 from recruitment, visit 5).
Physical Activity Questionnaire
Assess changes in physical activity between Phase 1 and Phase 2. Measured using the International Physical Activity Questionnaire (IPAQ) (7 items, quantitative, higher scores indicate higher levels of physical activity).
Measured: At the end of the study (week +24 from recruitment, visit 5).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start27 Jul 2025
- Primary completion24 Jan 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneal Dialysis (PD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aida Frías González
- Sponsor type
- University, hospital or other
- Collaborators
- Spanish Society of Nephrology, SOMANE (MADRID SOCIETY OF NEPHROLOGY), Hospital Universitario 12 de Octubre
- Responsible party
- Sponsor-investigator, Aida Frías González, Hospital Universitario 12 de Octubre
- Investigators
- Claudia Yuste Lozano, PhD, Principal investigator, Hospital 12 de Octubre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07326085
- Sponsor's protocol ID
- 23/187
- Acronym
- PUMA
- Status last verified
- Dec 2025
- First submitted
- 1 Dec 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of MiDialisis App Usage (Estudio Piloto de Uso de MiDiálisis App)
- ClinicalTrials.gov ID
- NCT07326085
- Acronym / sponsor ID
- PUMA / 23/187
- Conditions
- Peritoneal Dialysis (PD)
- Keywords
- peritoneal dialysys, remote monitoring
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Aida Frías GonzálezUniversity, hospital or other
- Collaborators
- Spanish Society of Nephrology, SOMANE (MADRID SOCIETY OF NEPHROLOGY), Hospital Universitario 12 de Octubre
- Study start
- 27 Jul 2025 (actual)
- Primary completion
- 24 Jan 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 8 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
This is a free smartphone app that collects information in three ways:
- The patient will enter their blood pressure and ultrafiltration values.
- They will receive a digital scale that sends their weight and body composition to the MiDiálisis app via Bluetooth.
- They will receive a smartband that sends information about their heart rate, sleep pattern, and physical activity to the MiDiálisis app via Bluetooth.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| INTERVENTION | Experimental | Device: Smart band, Device: Smart scale, Device: MiDialisis App, Device: Patients will install the app during the phase 2., Device: Patients will connect the digital scale., Device: Patients will connect the smartband.This group will recived the smart band, smart scale and the APP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smart bandDuring Phase 2, patients will use the smart band continuously throughout the day. | Device | INTERVENTION |
| Smart scaleDuring Phase 2, patients will weigh themselves daily using the scale. | Device | INTERVENTION |
| MiDialisis AppPatients will enter daily blood pressure data and information related to their peritoneal dialysis therapy. | Device | INTERVENTION |
| Patients will install the app during the phase 2.Patients will download and begin using the application. | Device | INTERVENTION |
| Patients will connect the digital scale.Patients will connect the digital scale to the application via Bluetooth. | Device | INTERVENTION |
| Patients will connect the smartband.Patients will connect the smartband to the application via Bluetooth. | Device | INTERVENTION |
Primary outcome
Feasibility and adherence
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.
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.
10 secondary outcomes
Perceived quality
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.
Usability
Time frame: After 8 weeks using MiDialisis dashboard (week +16 from recruitment, visit 4).
In-person Clinical care
Time frame: At the end of the study (week +24 from recruitment, visit 5).
telephone-based clinical care
Time frame: At the end of the study (week +24 from recruitment, visit 5).
unscheduled visits
Time frame: At the end of the study (week +24 from recruitment, visit 5).
overall clinical care
Time frame: At the end of the study (week +24 from recruitment, visit 5).
Kidney Disease Quality of Life-36
Time frame: At the end of the study (week +24 from recruitment, visit 5).
Kidney Disease and Quality of Life™ Short Form
Time frame: At the end of the study (week +24 from recruitment, visit 5).
Pittsburgh Sleep Quality Index
Time frame: At the end of the study (week +24 from recruitment, visit 5).
Physical Activity Questionnaire
Time frame: At the end of the study (week +24 from recruitment, visit 5).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Claudia Yuste Lozano, PhD principal investigator
Hospital 12 de Octubre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smart band, Smart scale and MiDialisis App in people with Peritoneal Dialysis (PD), run by Aida Frías González at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aida Frias, MD (+34667805030, midialisispuma@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility and adherence (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.