Prehypertension Clinical Trial
Official title:
Technology for Innovative Monitoring of Cardiovascular Prevention: A Precision Randomized Controlled Trial
National and international guidelines that guide evidence-based clinical practice advocate an
effort to improve blood pressure control based on changing lifestyle and use of blood
pressure lowering medication. However, the effectiveness of the approach usually depends on
patient adherence to both types of interventions - pharmacological and behavioral. Lack of
success on blood pressure control has increased the scope of interventions to improve
adherence and to reduce cardiovascular risk factors without overburdening the public health
system. The use of technologies - mobile or smart phones, games, blogs, internet and video
conferencing - to implement interventions can reduce costs and increase coverage.
Interactive interventions have been associated with a reduction in systolic blood pressure of
3-8 mmHg in patients with hypertension. These interventions were individually tailored to
patient specificities and involved self-monitoring of blood pressure and lifestyle changes,
including regular physical activity, DASH diet, restriction of dietary salt intake, and
weight control. However, the effectiviness of these interventions may have short half-lives
without periodic reinforcement, either to adhere to pharmacological treatment or behavioral
changes. Innovative technologies can be used to achieve lasting effect and even greater blood
pressure reduction.
Therefore, the purpose of this study is to compare effectiveness of four strategies to reduce
blood pressure and improve lifestyle.
This is a factorial randomized controlled trial of comparative effectiveness and precision medicine. Participants will be randomly assigned in a ratio of 1:1:2:1 to one of four arms: telemonitoring of blood pressure by smart phone, text message for lifestyle changes, both interventions (telemonitoring and messages) or usual clinical care. At randomization, all participants will receive a printed booklet with lifestyle modification guidelines. The standardized recommendation to adhere to the pharmacological treatment prescribed by the attending physician will also be implemented. These types of interventions do not allow the research assistant responsible for monitoring to be blinded, but the researcher resposible for the assessment of the outcome will be blinded to the allocated arm and the results will be evaluated through objective measurements. ;
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