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临床试验/NCT04699851
NCT04699851Unknown不适用

Optimization of the Management of COVID-19 Through Tailored Recommendations to the Citizens

Laval University2 个研究点 分布在 1 个国家目标入组 1,200 人开始时间: 2020年11月18日最近更新:
适应症

试验速览

阶段
不适用
入组人数
1,200
试验地点
2
主要终点
improvement in mask wearing behavior

研究概览

简要总结

People with chronic diseases including atherosclerotic heart disease, high blood pressure and diabetes are considered as a group with a high vulnerability. The COVID-19 pandemic ranging the world is rendering these people with chronic diseases even more vulnerable as they are subjected to a higher risk of COVID-19 related complications. General recommendations issued by the public health departments (PHD) do not take into consideration the personal situation of every citizen and therefore do not provide a personalized guidance to people with high vulnerability. The investigators hypothesis is that if participants receive adapted and personalized public health recommendations, they will be more adherent to the recommendations issued by the PHD and have better health outcomes than those who receive only general recommendations.

In the current trial, the investigators propose to co-develop a web-based portal (Vigie-COVID) that provides tailored recommendations based on the situation of each participant and adapted to the COVID-19 status, the behavior risk associated to contamination, the risk of complications and the health risks related to confinement. Using a cohort of people aged 18 and over in the province of Quebec, this randomized clinical trial will use a nested a double-blind experimental design where the tailored recommendations will be compared to the general recommendations of the PHD. The expected results from this trial include: 1) Improvement in the rate of compliance with the PHD recommendations in the group receiving the tailored recommendations; 2) Improvement of the quality and the quantity of the COVID 19 epidemiological data available for population health research in the Quebec region; 3) Decrease in the load in clinics (self-diagnosis); 4) Improving the state of health of individuals. The portal will be co-constructed in collaboration between various key players (citizens, patient partners, clinicians, researchers, companies, managers, decision-makers and representatives of the PHD) and aims to allow the recommendations of the PHD to be tailored according to the specific situation of each citizen-user in order to promote preventive behavior in times of pandemic. Overall, the ultimate goal is to obtain a global epidemiological portrait in order to identify the determinants and indicators of sustainable health and their impacts. After the pandemic, this might enable the implementation of a personalized monitoring of chronic diseases.

详细描述

The COVID-19 pandemic is raging in the world, including Quebec. As of May 22, 2020, more than 46,141 cases have been identified in Quebec, including 3,865 deaths. The virus causes heterogeneous clinical manifestations. People may be asymptomatic, have mild to moderate symptoms (cough, fever, myalgia), or a severe form requiring hospitalization and transfer to intensive care units. In a small proportion of people, it can cause death. Health emergency status was declared in Quebec on March 13, 2020 to allow the deployment of the measures suggested by the Public Health Department (PHD). Different types of recommendations (general, targeted, personalized and tailored) are available to optimize the prevention and management of COVID-19. General interventions are aimed at the entire population (eg: washing hands, keeping 2 meters apart). Targeted interventions target a vulnerable population (eg: patients with diabetes, the elderly, etc.). Personalized interventions are addressed specifically to a person, without necessarily being adapted to that person (eg: a general letter addressed to an individual by his name written in the header). The appropriate intervention considers the individual's reality (eg medical, environmental). Tailored interventions require a capacity for dynamic analysis and evaluation of information but are generally more effective in changing behavior (3). This evaluation also allows sorting of relevant information. Indeed, during a pandemic, a citizen may have a perception of contradictory information or be overloaded with information from different media. The tailored assessment allows citizens to have a clearer message in their reality. As mentioned above, in the case of COVID-19, the heterogeneity of symptom presentation implies different realities for each individual. In a potentially large proportion of cases, people may be asymptomatic or have mild to moderate flu-like symptoms. Thus, many infected people will not consult in the health network. It has been estimated that there are 10 times more people infected than those who are screened. Establishing a diagnosis of infected people is a key factor in ensuring a coherent epidemiological watch at the PHD. It is an indicator to monitor deconfinement and predict the second wave. COVID-19 infection is therefore a reportable disease. Moreover, diagnosing the disease in individuals with low symptoms makes them aware of their risk of transmission, as well as that of their contacts, so that they can adapt their behavior to the recommendations of the PHD. In addition, medical monitoring is critical in some vulnerable people with COVID-19. In fact, people aged 70 and / or suffering from certain chronic diseases (such as high blood pressure, atherosclerotic heart disease, obesity and diabetes) are at greater risk of developing the severe form of the disease. Citizens seem less inclined to consult their doctors during this period of disruption in the network. The preventive recommendations for these people, whether or not they have COVID-19, must be absolutely tailored in order to provide health care. Stricter preventive containment measures can have a negative impact on functional capacity or the risk of co-morbidities in this population due to changes in healthy lifestyle habits. Providing recommendations tailored to their situation on these habits (eg physical activity, healthy eating, sleep) could help reduce these negative effects.

In order to improve the health and safety of the population, the investigators propose to co-develop, with citizens, patient partners, clinicians, companies, managers, decision-makers and representatives of the PHD, a citizen portal in order to produce appropriate recommendations related to the COVID-19 status (positive or negative), the risk of complications (severity of symptoms and medical history), the risk of contamination (environmental prevalence of the disease) and the risks related to confinement. This portal will be adapted to level 2 literacy and validated by usability tests. From questionnaires self-administered to citizens, the tool will allow dynamic monitoring of symptoms related to COVID-19, collaborate with the PHD to improve the epidemiological portrait of the situation by identifying people who do not consult in the health system network and to bridge the gap with their family doctor.

Objectives: 1) Evaluate the feasibility of an efficient collaborative system between the PHD, citizens, patients and health professionals allowing the optimization of appropriate recommendations in both prevention and detection during the COVID-19 pandemic; 2) Produce recommendations concerning preventive behaviors related to COVID-19 tailored to the medical and environmental reality of each citizen; 3) Compare the proportion of users complying with the recommendations between those receiving tailored recommendations and those receiving general recommendations; 4) Observe the evolution of the state of health of individuals in real time by collecting socio-demographic, psychosocial and physiological data, including symptoms related to COVID-19, and data from measures surrounding confinement to the using a self-administered assessment tool.

Methodology:

Specification: This is a clinical intervention study of a cohort including a nested and randomized double-blind experimental design, where the tailored recommendations will be compared to the general recommendations. Population and sample: People aged 18 and over, residing in the Quebec City area, will be solicited according to an advertising strategy and different collaborations which will enable the access to a cohort of 1407 participants (as of May 22, 2020).

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
Single (Participant)

盲法说明

Participant do not know if they received tailored or general recommendations.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 years old
  • Living in Canada
  • Able to give an informed consent

排除标准

  • 未提供

结局指标

主要结局

improvement in mask wearing behavior

时间窗: 3 months

The measure will be the frequency of mask wearing when the participant is in a situation where it is recommended by public health to wear the mask

improvement in daily fruit consumption

时间窗: 3 months

the measure will be the portion of fruit and vegetables consumed per day

improvement in the amount of daily sleep hours

时间窗: 3 months

The measure will be the amount of hour of sleep by day

improvement in social distancing behavior

时间窗: 3 months

The measure will be the frequency of social distancing (2 meters or more) when the participant is in a situation where it is recommended by public health.

improvement in hand washing behavior

时间窗: 3 months

The measure will be the frequency of hand washing when the participant is in a situation where it is recommended by public health.

improvement in the amount of weekly minutes of exercise

时间窗: 3 months

The measure will be the amount of minutes of moderate to intense exercise by week

次要结局

  • Platform participation(3 months)
  • Platform sustainability long term(3 months)
  • Platform sustainability short term(3 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jean-Sébastien Paquette

Principal Investigator

Laval University

研究点 (2)

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