Remote monitoring programm based on mobile application for patients on peritoneal dialysis. Urological and Genital Diseases
Conditions
Interventions
The trial contemplates a 24-week follow-up. Patients will be randomly assigned to the program with remote monitoring based on an application for mobile devices (PMA) or to standard health care (withou
Sponsors
Baxter Healthcare Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient =18 and =85 years of age. 2. Being diagnosed with chronic kidney disease with renal failure. 3. Being a prevalent PD patient (having reached day 90 in a chronic PD program) 4. Having a smart phone (patient or caregiver) that meets the conditions for installing the application (App).
Exclusion criteria
Exclusion criteria: 1. A patient who does not provide informed consent to participate in the study. 2. If the patient is female, pregnancy status. 3. Patients with a prescription for peritoneal dialysis due to a non-renal cause (e.g., cardiorenal). 4. Patients with cirrhosis or hepatic cancer. 5. A patient who is currently participating or has participated in a clinical trial within the last 30 days. 6. Patients with a sensory or cognitive compromise that prevents adequate interaction with the mobile device app.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient/renal clinical interaction, assessed by: 1. Number of changes in dialysis prescription per patient on follow-up from the start of follow-up for up to 24 weeks. 2. Documented frequency of patient-clinic and clinic-patient communications from start of follow-up for up to 24 weeks; and 3. Number of preventive visits to the renal clinic at six (6) months follow-up. These visits are defined as those that are not the regular monthly scheduled visits, that are cited by the clinical staff, and that are intended to proactively intervene in any condition detected in the patient, will be recorded from the start of follow-up for up to 24 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Impact on clinical interventions, measured as: 1. Changes in the number of antihypertensives prescribed per patient at 24-week follow-up. 2. Number of emergency department visits per patient at six-month follow-up. 3. Number of hospitalizations per patient at six-month follow-up. 4. Health-related quality of life measured at baseline and at six months (week 24), measured with the KDQoL-36 and PROMIS-29 profile v2.1 instruments. 5. Evaluation of the usability of the cell phone application assessed with the mHealth App Interactive Usability Questionnaire (MAUQ) instrument for patients and health professionals. This evaluation will be performed in week 4 of use and only for the arm randomized to the cell phone application. | — |
Countries
Colombia
Outcome results
None listed