Introduction:
The utilization of novel information and communication technologies (ICT) within the healthcare sector can lead to an improved quality of life and better disease management. Diabetic kidney disease (DKD) stands as the most prevalent cause of end-stage chronic kidney disease (CKD), contributing to a heightened risk of renal complications and increased cardiovascular mortality and/or necessity for renal replacement therapy in affected patients. A preliminary study conducted on patients with DKD revealed that prolonged usage of the NORA app resulted in elevated levels of treatment adherence and enhanced disease management. This study's primary aim is to examine the impact of monitoring CKD patients through the NORA application on the management of risk factors associated with the progression of kidney disease. These risk factors are delineated as a composite renal event (MARE), encompassing a 50% decline in glomerular filtration rate, commencement of renal replacement therapy, or occurrence of cardiovascular or renal-related fatalities. This analysis presents the initial characteristics of the recruited individuals, comparing them between the control and intervention groups.
Methods:
The NORA app multicenter randomized clinical trial (PR(AG)608/2021) has set inclusion criteria targeting individuals aged 18 years or older, diagnosed with DKD at stage G3bA3 or higher (eGFR CKD-EPI < 45 ml/min/m² and alb/creat > 300 mg/g), and equipped with a smartphone (either owned by the participant or a family member) capable of utilizing applications such as WhatsApp. Exclusion criteria encompass patients diagnosed with DKD at stage G3bA2 or lower, as well as those classified at stage G5 (eGFR < 15 ml/min/m²) expected to necessitate renal replacement therapy within a year or less. The NORA app has been designed as a smartphone application to monitor risk factors, disseminate educational medical content, enable communication with healthcare professionals via chat, enhance treatment adherence (Morisky-Green), and gather patient-reported outcomes such as anxiety and depression, utilizing the HAD scale. Clinical-laboratory variables will be assessed every three months and compared with control patients.
Results:
Between 01/04/2022 and 12/15/2023, a total of 100 patients were recruited (46 in the control group and 54 in the intervention group). The average age in the control group was 76 years, whereas it was 63 in the intervention group. Male individuals constituted 73.91% of the control group and 68.63% of the intervention group. The primary comorbidities observed in both groups included arterial hypertension, dyslipidemia, obesity, and ischemic heart disease. In the control group, the mean creatinine level was 1.90±0.47 mg/dL, eGFR 31.8±7.7 ml/min/1.73m², and urinary albumin creatinine ratio (UACR) 1095±856 mg/gr, while in the intervention group, it was 1.94±0.49 mg/dL, eGFR 31.2±7.9 ml/min/1.73m², and UACR 1299±1181 mg/gr. The HbA1C level in the control group was 7.01±0.86%, whereas in the intervention group, it was 7.12±0.8.
Conclusions:
The trial aims to evaluate the impact of personalized monitoring of patients with DKD at stage G3bA3 or higher using the NORA application to delay the progression of kidney disease.
I have no potential conflict of interest to disclose.
I did not use generative AI and AI-assisted technologies in the writing process