Effectiveness of a mobile-health application for glycemic and blood pressure control in patients with comorbid type 2 diabetes and hypertension : a randomized controlled trial

Abstract

Background: Mobile technology-based health interventions have emerged as promising tools to aid chronically ill patients through engaging in self-management of their health conditions. Mobile-health (m-health) applications (apps) are the most common delivery modality for m-health interventions, and can be used to address constraints in conventional self-management approaches. However, the clinical effectiveness of m-health apps developed to aid patients’ self-management process remains unclear. The aim of the present study was to evaluate whether patients with comorbid type 2 diabetes and hypertension would exhibit improved glycemic and blood pressure (BP) control when their disease self-monitoring process is supported by a tablet-based self-monitoring health app. Methods: A 24-week randomized controlled trial was designed to determine the effects of the self-monitoring health app on patients’ clinical, behavioral, and usage outcomes. A total of 299 participants with comorbid type 2 diabetes and hypertension were recruited from two hospitals in Hong Kong. They were randomly allocated to intervention (n = 151) or control groups (n = 148). Patients in the intervention group received a tablet-based self-monitoring health app to support their self-monitoring processes, while control group patients continued their usual care. Clinical outcomes included hemoglobin (HbA1c), fasting blood glucose (FBG), systolic BP, and diastolic BP. Behavioral outcomes included medication adherence, general adherence to treatment, and adherence to disease-specific activities. Usage outcomes included the frequency of self-monitoring of BG (SMBG) and the frequency of self-monitoring of BP (SMBP). Outcome measurements were collected in patients’ homes at weeks 0 (baseline), 8, 12, 16, and 24. Between-group differences were examined using linear mixed-effects models with an intention-to-treat principle. Correlation analyses were performed to examine the relationships between the frequency of self-monitoring and clinical outcome improvements. Results: After 24 weeks, significant improvements in HbA1c and adherence to disease-specific activities were observed in both intervention and control groups (all p values < 0.05). When compared to baseline values, intervention participants yielded higher FBG after 24 weeks (p = 0.002). No significant difference was observed in all other outcomes after 24 weeks in the two groups. Additionally, when compared to the control group, the intervention group did not yield greater improvement in any of the outcomes after 24 weeks. Results from correlation analyses indicated that participants performing more SMBG tended to exhibit greater improvement in HbA1c in both groups (r = 0.23, p = 0.006 for the intervention group; r = 0.23, p = 0.005 for the control group). Conclusions: Although the present study did not elucidate a beneficial effect of the intervention over the control group, there remains significant potential for further growth of the m-health apps. The findings of this study call for further investigations to establish the effects of m-health apps and explore improved strategies for the design and implementation of such tools. (Words 454)