Personalized Health Education Against the Health Damage of COVID-19 Epidemic in Hungary (PROACTIVE-19)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 449
- 试验地点
- 2
- 主要终点
- Primary composite rate of intensive care unit (ICU) admission, 48 hours of hospital admission, death in COVID-19 positive cases
研究概览
简要总结
The additional effect of personalized health education compared to general education following the internationally accepted principles will be evaluated in the prevention of the serious course of the novel coronavirus infection. It is hypothesised that personalized health education provides a greater degree of lifestyle change, thus the risk of a serious course of infection decreases.
详细描述
PROACTIVE-19 is a pragmatic, randomized controlled clinical trial with adaptive "sample size re-estimation" design. Volunteers will be randomized into two groups: (A) generalized health education; (B) personalized health education. Participants will go through phone questioning and recommendation in 5 fields: (1) mental health (2) smoking habits, (3) physical activity, (4) dietary habits, (5) alcohol consumption. Both groups A and B will receive the same line of questioning to assess habits concerning these topics. In Group A: questioning will be done in sequence followed by a shared minimal intervention aimed towards improvement of these factors but without any personalized recommendation. In Group B: each assessment will be followed by specific and personalized recommendations. Assessment will be done weekly during the first month, every second week in the second month, then monthly. Considering one interim analysis for efficacy the estimated sample size is 3788 (rounded up to 3800) subject per study arm. The planned duration of the follow up is a minimum of one year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Subjects will be blinded to knowledge of the details of differences between the interventions.
Everyone else (outcome assessors, caregivers and data analysts) will be blinded regarding the allocation.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Primary composite rate of intensive care unit (ICU) admission, 48 hours of hospital admission, death in COVID-19 positive cases
时间窗: 12 months
The primary endpoint will be the composite of the rate of the followings in COVID-19 positive cases (verified by an accredited laboratory): the number of pariticipants with ICU (intensive care unit) admission; 48 hours of hospitalisation and/or death. 48 hours of hospitalisation for the following reasons: (I) arrhythmia (causing hemodynamic instability and requiring continuous monitoring and/or cardiac support, as indicated by mean arterial pressure \<65 mm Hg, and/or serum lactate \>2 mmol/L) and/or (II) Acute Respiratory Distress Syndrome (ARDS): severe hypoxaemic respiratory failure indicated by a Partial Pressure of Oxygen (PaO2)/Fraction of inspired oxygen (FiO2) \<300 mmHg according to the Berlin definition and/or (III) circulatory shock (the requirement of continuous vasopressor support to maintain mean arterial pressure \<65 mmHg and/or serum lactate \>2 mmol/L)
次要结局
- The number of emergency, hospital admission and intensive care admission(12 months)
- The number of general practitioner visits(12 months)
- Length of hospitalization and intensive care unit stay(12 months)
- Lifestyle changes(12 months)
- Organ dysfunction(12 months)
- The cost of care(12 months)
研究者
Dr Hegyi Péter
Principal Investigator, Director of the Centre for Translational Medicine at University of Pécs
University of Pecs