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

Официальное название

Pilot Study of MiDialisis App Usage (Estudio Piloto de Uso de MiDiálisis App)

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Smart band
  During Phase 2, patients will use the smart band continuously throughout the day.
• Устройство Smart scale
  During Phase 2, patients will weigh themselves daily using the scale.
• Устройство MiDialisis App
  Patients will enter daily blood pressure data and information related to their peritoneal dialysis therapy.
• Устройство Patients will install the app during the phase 2.
  Patients will download and begin using the application.
• Устройство Patients will connect the digital scale.
  Patients will connect the digital scale to the application via Bluetooth.
• Устройство Patients will connect the smartband.
  Patients will connect the smartband to the application via Bluetooth.

Первичные конечные точки

• Feasibility and adherence [Срок оценки: 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.]

Вторичные конечные точки (10)

• Perceived quality [Срок оценки: 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 [Срок оценки: After 8 weeks using MiDialisis dashboard (week +16 from recruitment, visit 4).]
• In-person Clinical care [Срок оценки: At the end of the study (week +24 from recruitment, visit 5).]
• telephone-based clinical care [Срок оценки: At the end of the study (week +24 from recruitment, visit 5).]
• unscheduled visits [Срок оценки: At the end of the study (week +24 from recruitment, visit 5).]
• overall clinical care [Срок оценки: At the end of the study (week +24 from recruitment, visit 5).]
• Kidney Disease Quality of Life-36 [Срок оценки: At the end of the study (week +24 from recruitment, visit 5).]
• Kidney Disease and Quality of Life™ Short Form [Срок оценки: At the end of the study (week +24 from recruitment, visit 5).]
• Pittsburgh Sleep Quality Index [Срок оценки: At the end of the study (week +24 from recruitment, visit 5).]
• Physical Activity Questionnaire [Срок оценки: At the end of the study (week +24 from recruitment, visit 5).]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• Hospital 12 de Octubre — Madrid

Идентификаторы

NCT: NCT07326085 · 23/187

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗