The Optimising Isolation, Quarantine and Distancing Study for COVID-19 (Optimise)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- What are the types of social contacts and mixing patterns of COVID-19 cases
研究概览
简要总结
The Australian government swift interventions and actions early to the COVID 19 epidemic included enforced quarantine, isolation, varying degrees of social and physical distancing measures, travel restrictions, community level testing and enhanced contact tracing models which effected the trajectory of the epidemic impact. While the search for effective therapeutics and vaccines continues, it is important to understand how to effectively implement and optimise the current public health interventions available; application of traditional contact tracing , contributions of new contact tracing mobile phone applications, community level testing and use of specific fit for purpose diagnostic tests; to screen, detect and provide evidence of infection clearance.
While the suppression measures have been effective on disease transmission rates, it has had economic, social and non COVID-19 health costs impacts. As community restrictions change it will be important to monitor and evaluate the effectiveness of these key interventions. This is a longitudinal study that will follow the experience and behaviors of 2 key risk populations impacted by COVID-19 transmission containment measures.
详细描述
This is a mixed methods longitudinal study of a cohort of 1000 participants for a 18 month period. Victorian adults from three key risk populations will be recruited into two longitudinal cohort groups. It will follow the experiences and behaviors of the groups; Recruitment group 1/Seed set 1 - recently diagnosed 'COVID-19 cases' (Group 1) and their social network with up to 2 waves of /Key people, will be followed up for 1 month initially with specific monitoring tools before they will transition into ongoing follow up and monitoring as recruitment group 2 Recruitment group 2/Seed set 2 - people from the general community that are not currently infected with COVID19 'Group 2' that are practicing physical distancing and represent specific key risk groups, and their social network with up to 2 waves of Key people.
Over sampling of vulnerable populations including people with disabilities, single parents and people living alone will be conducted across all groups. Individuals may be invited to participate in more than one cohort when they change between risk population definitions.
The project aims to meet the following objectives using a longitudinal cohort design and a mixed method of qualitative and quantitative tools to enable us to assess changes within individuals over time and to assess the influence of social networks on their health, well-being, attitudes and perceptions.
Objectives of the study are:
- To assess adherence to government intervention strategies (i.e. early testing, isolation and physical distancing) and identify factors that promote/inhibit compliance to intervention strategies designed to reduce transmission.
- To better understand, assess and monitor the unintended health, social and economic consequences of the government interventions to control COVID-19 transmission
- To collect and collate empirical data regarding transmissions dynamics, social contacts and mixing patterns of COVID19 cases , their contacts and key vulnerable groups to develop and refine mathematical models that will improve the precision and timeliness of dynamic transmission estimates.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Community participants
排除标准
- •Unable to provide consent
结局指标
主要结局
What are the types of social contacts and mixing patterns of COVID-19 cases
时间窗: 18 months
The questionnaire participants will be ask to complete will include nominating the relationship with their contacts per day(i.e. partner, child, friend), and individuals COVID test status, providing detailed specifics of the projects social network data
Change from response in baseline questionnaires depicting what are the unintended health, social and economic consequences of the government response to control COVID19 transmission
时间窗: 18 months
Using data from baseline and follow up questionnaires the researchers will calculate both an individual and a composite variable to assess the following unintended consequence, including: * Loss of job during COVID-19 period * Decline in income during COVID-19 period * Disruption to schooling or education during COVID-19 period * Decline in work productivity during COVID-19 period * Change in responsibilities to care for others * Decrease in healthcare utilization during COVID-19 period * Increase in alcohol (frequency or quantity) and other drug consumption during COVID-19 period * Change in mental health or personal wellbeing during COVID-19 period * Increase in social connectedness during COVID-19 period A scale is not being applied in above responses; options for response are in place. * Anxiety (using GAD scale: https://patient.info/doctor/generalised-anxiety-disorderassessment-gad-7) is a response section in the questionnaire.
What are the social contacts and mixing patterns of COVID-19 cases
时间窗: 18 months
The questionnaire participants will be ask to complete include nominating the number of contacts per day and the time will permit collation of social network data. Using data from the daily diaries (retrospective and prospective) the researchers will calculate: * Numbers of contacts per day * Numbers of contacts by type of activity * Time spent doing each type of activity per day * Time from symptom onset to self-isolation * Time from symptom onset to accessing diagnostic testing * Time from accessing testing to result receipt (diagnosis) * Time from result receipt (diagnosis) - to contact by contact tracing team A scale is not being used.
Change from response in baseline questionnaires to Adherence (non-adherence) with COVID19 transmission containment measures
时间窗: 18 months
Participants will complete questionnaires and diaries as binary daily measure of outcomes of compliance/nonadherence for each individual, determined by their ability to adhere to government regulations
Measure of the efficacy of government interventions
时间窗: 18 months
Participants responses to questionnaires, focus group discussions will be used as binary measurers; The researchers will not be using a scale, reporting will be in the format: * Number and % of participants that reported correct knowledge of government guidance regarding isolation, quarantine and physical distancing requirements - calculated as a binary outcome (Yes/No) and also as a combined knowledge score * Number and % of participants that report using COVID-19 prevention measures advised by the Governments. For example: * 560/700 (80%) participants report regularly using hand sanitizer and/or washing hands * 680/700 (97%) of participants report applying physical distancing rules as much as I can (i.e. keeping 1.5 metres away from others, not shaking hands) * Number and % of participants that reported COVID-19 related symptoms that were tested for SARS-CoV-2 infection, and results of these tests
次要结局
- Collect and collate empirical data of COVID19 cases, contacts and key vulnerable groups(18 months)
- Assess the effectiveness of government interventions to reduce COVID-19 transmission from questionnaire responses from cohort participants(18 months)