Pilot Study to Evaluate the Feasibility, Adherence and Acceptance of the MiDiálisis Platform for Patients on PD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Smart band, Smart scale, MiDialisis App, Patients will install the app during the phase 2..
- Who it may be relevant to
- Registry conditions: Peritoneal Dialysis (PD). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Pilot Study of MiDialisis App Usage (Estudio Piloto de Uso de MiDiálisis App)
Overview
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:
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.
Interventions
- Device Smart band
During Phase 2, patients will use the smart band continuously throughout the day. - Device Smart scale
During Phase 2, patients will weigh themselves daily using the scale. - Device MiDialisis App
Patients will enter daily blood pressure data and information related to their peritoneal dialysis therapy. - Device Patients will install the app during the phase 2.
Patients will download and begin using the application. - Device Patients will connect the digital scale.
Patients will connect the digital scale to the application via Bluetooth. - Device Patients will connect the smartband.
Patients will connect the smartband to the application via Bluetooth.
Primary outcome measures
- 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.]
Secondary outcome measures (10)
- 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).]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Spain · 1 center
- Hospital 12 de Octubre — Madrid
Identifiers
NCT: NCT07326085 · 23/187