The Impact of Mobile Health on Blood Pressure and Health Literacy in Chronic Kidney Disease: Randomized Open-Label Clinical Trial (Preprint)

Abstract

BACKGROUND Mobile health (mHealth) management is an emerging therapeutic strategy for chronic diseases. Although it has been shown to improve self-care management and assist in the early detection of a worsening health status. Its effect on blood pressure (BP) control and health literacy (HL) in patients with chronic kidney disease (CKD) has not been well-studied. OBJECTIVE This randomized open-label clinical trial aimed to examine the effectiveness of mHealth on BP control and HL in CKD. METHODS We designed and developed a new mHealth, called iCKD. The application has several major features, including BP monitoring, alarms and a warning system. We randomly assigned 122 CKD patients (stages 1-3a: 28, stage 3b: 46, stage 4-5: 48) to use iCKD or paper-based education (placebo) to monitor office BP. Trained nurses interviewed the patients using structured questionnaires to evaluate HL. The primary and secondary efficacy endpoints were office BP less than 130/80 mmHg and total HL score after 6 months, respectively. RESULTS In the intention-to-treat analysis, baseline kidney function and office BP were not significantly different between the iCKD and placebo groups at enrollment. At the end of the 6-month study period, 21 participants had withdrawn, and 22 of 52 participants (42.3%) in the iCKD group and 11 of 49 participants (22.4%) in the placebo group reached the optimal office BP of 130/80 mmHg (p=0.03). The patients who reached the BP target had higher total HL score than those who did not, and the iCKD group had a greater increase in total HL score than the placebo group (p=0.01). CONCLUSIONS A higher proportion of the iCKD group reached the target BP value and had better HL scores than the placebo group. Our findings demonstrate that mHealth can improve HL and BP status in CKD patients, suggesting its potential application in clinical CKD care. CLINICALTRIAL NCT03649516