JMIR Publications

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 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 mHealth called iCKD, a Healthcare Technology Platform, a digital learning and information service for CKD management. The application has several major features, including BP monitoring, alarms and a warning system. We randomly assigned 122 CKD patients to use iCKD or paper-based education (usual care, non-iCKD). The efficacy endpoints were office BP < 140/90 and 130/80 mmHg and total HL score after intervention for 6 months respectively. Trained nurses interviewed the patients using structured questionnaires to evaluate HL including five dimensions: accessing, understanding, appraising, applying health information, and communication and interaction.

Results:

Of 122 participants, 61 were assigned to iCKD group and 61 to non-iCKD group. Mean age was 66.9 ± 12.3 years, and 63 % (77/122) were male. Baseline kidney function and office BP were similar between groups. Both groups showed reductions in BP during the study. In intention-to-treat (ITT) analysis, the proportion achieving <140/90 mmHg increased from 54.1 % (33/61) to 76.9 % (40/52) in the iCKD group and from 49.2 % (30/61) to 59.2 % (29/49) in the non-iCKD group. For the stricter <130/80 mmHg target, improvements were more pronounced in the iCKD group, and in per-protocol (PP) analysis revealed 42.3 % (22/52) of iCKD participants versus 22.4 % (11/49) of non-iCKD participants achieved this goal (P=.03). Both groups showed improvements in total HL and the accessing domain, while only iCKD participants demonstrated significant gains in appraising health information. Patients who achieved BP targets also exhibited greater HL improvements, with the most multi-domain improvements observed in the iCKD achievers.

Conclusions:

Using the iCKD app was associated with a higher likelihood of achieving optimal BP control and selective improvements in higher-level HL domains, particularly appraising health information. These findings suggest that mHealth can enhance both BP control and HL in CKD patients, supporting its potential role in integrated, patient-centered CKD care

ClinicalTrial:

Clinicaltrials.gov NCT03649516.