Patient mobile application for peritoneal dialysis patients: a pilot study

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2022
INTERVENTION: 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 (without PMA). Patients belonging to the renal clinics selected for the study who meet the inclusion criteria and do not meet the exclusion criteria will be invited to participate in the experiment, under a rigorous informed consent process. Once the patient accepts the invitation to participate, compliance with the participation criteria will be evaluated in detail, and he/she will then be randomly assigned to one of the two arms of the study. Patients assigned to the intervention arm (remote monitoring program based on a mobile device application) will be trained in the use of the application, and in the adjustments to the care plan that will be made within the remote monitoring program. Baseline assessments will be performed in both groups and follow‐up will be initiated for up to 24 weeks. Randomization is performed using an online tool based on REDCap (Research Electronic Data Capture). CONDITION: Remote monitoring programm based on mobile application for patients on peritoneal dialysis. ; Urological and Genital Diseases PRIMARY OUTCOME: ; 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.; 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). SECONDARY OUTCOME: ; 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.;
Epistemonikos ID: ac3707ac6d63a5974ad3d7731f6ce2921a06b61d
First added on: Aug 25, 2024