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Randomized Controlled Trial
. 2020 Mar 11;15(3):e0229483.
doi: 10.1371/journal.pone.0229483. eCollection 2020.

Remote blood pressure monitoring and behavioral intensification for stroke: A randomized controlled feasibility trial

Beom Joon Kim  1 , Jong-Moo Park  2 , Tai Hwan Park  3 , Joungsim Kim  1 , JongShill Lee  4 , Keon-Joo Lee  1 , JiSung Lee  5 , Jae Eun Chae  6 , Lehana Thabane  7   8 , Juneyoung Lee  6 , Hee-Joon Bae  1
Affiliations
Randomized Controlled Trial

Remote blood pressure monitoring and behavioral intensification for stroke: A randomized controlled feasibility trial

Beom Joon Kim et al. PLoS One. .

Abstract

Measuring blood pressure (BP) at home and remote monitoring can improve the patient's adherence to BP control and vascular outcomes. This study evaluated the feasibility of a trial regarding the effects of an intensive mobile BP management strategy versus usual care in acute ischemic stroke patients. A feasibility-testing, randomized, open-labeled controlled trial was conducted. Remote BP measurement, data transmission, storage, and centralized monitoring system were organized through a Bluetooth-equipped sphygmomanometer paired to the participants' smartphones. Participants were randomized equally into intensive management (behavioral intensification to measure BP at home by texting, direct telephone call, or breakthrough visit) and control (usual care) groups. The primary feasibility outcomes were: 1) recruitment time for the pre-specified number of participants, 2) retention of participants, 3) frequency of breakthrough visit calls, 4) response to breakthrough visit call, and 5) proportions satisfying BP measurement criteria. Sixty participants were randomly assigned to the intensive management (n = 31) and control (n = 29) groups, of which 57 participants were included in the primary analysis with comparable baseline characteristics. Recruitment time from the first to the last participant was 350 days, and 95% of randomized participants completed the final visit (intensive, 94%; control, 98%). Eight breakthrough visit calls were made to 7 participants (23%), with complete and immediate responses within 3 ± 4 days. The median of half-day blocks fulfilling the BP measurement criteria per patient were 91% in the intensive group and 83% in the control group (difference, 12.2; 95% confidence interval, 2.2-22.2). No adverse events related to the trial procedures were reported. The intensive monitoring, including remote BP measurement, data transfer, and centralized monitoring system, engaged with behavioral intensification was feasible if the patients complied with the intervention. However, the device utilized would need further improvement prior to a large trial.

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Conflict of interest statement

This trial was financially supported by a research fund from Daiichi-Sankyo Pharmaceuticals, but the sponsor had no role in design, data collection, analysis, interpretation and preparation of the manuscript. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

Figures

Fig 1
Fig 1. Study profile and subject disposition.
Fig 2
Fig 2. Overall trial design.
Fig 3
Fig 3. Remote BP measurement, data transmission, storage, and centralized BP monitoring system.
Fig 4
Fig 4. BP measurements during trial period.
See this image and copyright information in PMC

References

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