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Clinical Trials/NCT07337382
NCT07337382Active, not recruitingNot Applicable

The Optimising Isolation, Quarantine and Distancing Study for COVID-19

Macfarlane Burnet Institute for Medical Research and Public Health Ltd2 sites in 1 country1,000 target enrollmentStarted: September 30, 2020Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
Enrollment
1,000
Locations
2
Primary Endpoint
Change from response in baseline questionnaires to Adherence (non-adherence) with COVID19 transmission containment measures

Study Overview

Brief Summary

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.

Detailed Description

This is a mixed methods longitudinal study of a cohort of 1000 participants for a 12 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.

Oversampling 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.

Study Design

Study Type
Observational
Observational Model
Ecologic Or Community
Time Perspective
Other

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Community participants -

Exclusion Criteria

  • Unable to provide consent -

Arms & Interventions

Observational Group 1

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

Observational Group 2

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

Outcomes

Primary Outcomes

Change from response in baseline questionnaires to Adherence (non-adherence) with COVID19 transmission containment measures

Time Frame: 18 months

Participants will complete behavioural questionnaires and diaries as binary daily measure of outcomes of compliance/non-adherence for each individual, determined by their ability to adhere to government regulations

Change from response in baseline questionnaires depicting what are the unintended health, social and economic consequences of the government response to control COVID19 transmission

Time Frame: 18 months

Participants will complete behavioural questionnaires and diaries. e.g. Anxiety (using GAD scale: https://patient.info/doctor/generalised-anxiety-disorder-assessment-gad-7).

What are the social contacts and mixing patterns of COVID-19 cases

Time Frame: 18 months

The behavioural questionnaire participants will be ask to complete include nominating the number of social network contacts per day.

Measure of the efficacy of government interventions,

Time Frame: 18 months

Participants responses to behavioural questionnaires and focus group discussions will be used as binary measurers; including but not limited to the number/proportion of participants who receive a score indicating accurate knowledge of government recommendations, receive a score of using COVID-19 prevention measures as recommended by the government.

What are the types of social contacts and mixing patterns of COVID-19 cases

Time Frame: 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.

Secondary Outcomes

  • Collect data of positive COVID19 cases reported in study participant questionnaires.(18 months)
  • To investigate new and alternative tests to diagnose COVID-19.(18 months)
  • Assess the effectiveness of government interventions to reduce COVID-19 transmission from questionnaire responses from cohort participants(18 months)

Investigators

Sponsor
Macfarlane Burnet Institute for Medical Research and Public Health Ltd
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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