Accepted for/Published in: JMIR mHealth and uHealth
Date Submitted: Apr 21, 2024
Date Accepted: Mar 17, 2025
Impact of 12-month mHealth Home Telemonitoring on Clinical Outcomes in Older Individuals with Hypertension and Type 2 Diabetes: A Multicenter Randomized Controlled Trial
ABSTRACT
Background:
There is limited evidence on the clinical effectiveness of mHealth home telemonitoring in older people with arterial hypertension (AH) and type 2 diabetes (T2D) in primary care settings. As the population ages and these conditions become more prevalent, it is important to understand the impact of telemonitoring and tailor mHealth interventions accordingly.
Objective:
To evaluate the impact of 12-month telemonitoring on clinical outcomes in older individuals with AH and T2D compared to standard care in primary care setting.
Methods:
In a multicenter randomized controlled trial, patients aged 65 years or older with AH and T2D were randomized in a 1:1 ratio to telemonitoring or standard care. The telemonitoring group received enhanced mHealth support. Over 12 months, participants measured blood pressure (BP) twice weekly and blood glucose (BG) once monthly, with intensified monitoring and teleconsultations in response to deviations. The primary outcomes were the differences between groups in the change in systolic BP (SBP) and HbA1c levels at 12 months after inclusion from baseline. Secondary outcomes included changes in diastolic BP, fasting BG, lipid profile, body mass index, appraisal of diabetes, and behavioral risk factors.
Results:
Initially, 128 patients were enrolled, with 117 (91.4%) completing the 12-month follow-up. The mean age was 71.3±4.7 years, with a mean systolic BP of 136.7±14.1 mmHg and mean HbA1c of 7.2±1.0%. At baseline, there were no significant differences between groups. After 12 months, the telemonitoring group exhibited a significant reduction in SBP (-6.9 mmHg, 95% CI -11.0 to -2.7, P=.001) and HbA1c (-0.5%, 95% CI -0.8 to -0.2, P=.002) compared to the control group. No significant differences were found in secondary outcomes.
Conclusions:
Telemonitoring effectively improves BP and BG control in older individuals but has no impact on other cardiovascular risk factors and diabetes-related quality of life. Future research should integrate educational and behavioral components into telemonitoring to reinforce lifestyle changes. However, complex interventions may pose challenges for the elderly, highlighting the need for careful patient selection to ensure that the benefits outweigh potential burdens. Clinical Trial: ISRCTN Registry (https://doi.org/10.1186/ISRCTN31471852).
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