Technology for Innovative Monitoring of Cardiovascular Prevention: A Precision Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 入组人数
- 231
- 试验地点
- 2
- 主要终点
- Ambulatory blood pressure monitoring (ABPM)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Participants have uncontrolled hypertension under on pharmacological treatment. They will be requested not to change drugs and medicine doses during the trial.
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Office blood pressure: systolic blood pressure greater or equal to 135 mmHg and below 180 mmHg or diastolic blood pressure greater or equal to 85 mmhg and below 110 mmhg
- •Ambulatory Blood Pressure Monitoring (ABPM): 24h-SBP ≥130 mmHg or 24h-DBP ≥80 mmHg
- •Use of one or two blood pressure lowering drugs
- •Have a smartphone
排除标准
- •Cardiovascular event in the last 6 months (eg myocardial infarction, stroke, pacemaker or other use)
- •Life threatening conditions, low life expectancy
- •Inability to measure blood pressure;
- •Previous diagnosis of secondary hypertension;
- •IF WOMAN: lactating, pregnancy or who intend to become pregnant within the next 6 months.
- •Unable to understand the interventions
研究组 & 干预措施
TELEM group
Participants in the telemonitoring home blood pressure group will receive an oscillometric monitor to measure blood pressure at home for six months. Measurements will be made for at least five days a week (including one day during the weekend). Each blood pressure measure will be sent to the center of the study coordination center through software downloaded on the participant's smartphone.
干预措施: TELEM (Device)
TELEMEV group
In the telemonitoring of lifestyle group, participants will receive customized standardized text messages to stimulate lifestyle changes and adherence to blood pressure lowering medication. The messages will be focused on the adoption of DASH diet, sodium restriction, increase of physical activity, weight control and adherence to drug treatment. They will be sent to the smarphones on four of the five days of the week at random times using a software developed for this study.
干预措施: TELEMEV (Device)
TELEM-TELEMEV group
Participants in the telemonitoring home blood pressure plus telemonitoring of lifestyle group (TELEM-TELEMEV) will receive both interventions as previously described.
干预措施: TELEM-TELEMEV (Device)
Usual clinical treatment (UCT)
Participants in the control group will be under antihypertensive treatment, chosen at the discretion of the assistant physician. Participants will not receive any technological tool to stimulate blood pressure control or lifestyle modification.
干预措施: UCT (Other)
结局指标
主要结局
Ambulatory blood pressure monitoring (ABPM)
时间窗: Change at six months (end of the trial)
Reduction in 24h-systolic blood pressure
次要结局
- ABPM(Change at six months (end of the trial))
- Other ABPM measurements(Change from baseline to end of the trial)
- Office blood pressure(At six months (end of the trial))
- Reduction in sodium urinary excretion(Change at six months (end of the trial))
- Improvement of lifestyle: increase of regular physical activity, intake of DASH-type diet, or weight reduction(Change at six months (end of the trial))
研究者
Sandra Costa Fuchs
Professor Sandra C. Fuchs, MD, PhD
Hospital de Clinicas de Porto Alegre