Previously submitted to: JMIR mHealth and uHealth (no longer under consideration since Oct 17, 2025)
Date Submitted: Nov 20, 2024
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
The Impact of Mobile Health on Blood Pressure and Health Literacy in Chronic Kidney Disease: Randomized Open-Label Clinical Trial
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 At the end of the 6-month study period, 21 participants had withdrawn, and 22 of 52 participants (42.3%) in the iCKD group and 11 of 49 participants (22.4%) in the placebo group reached the optimal office BP of 130/80 mmHg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. Clinical Trial: NCT03649516
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