- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07337382
The Optimising Isolation, Quarantine and Distancing Study for COVID-19 (Optimise)
Study Overview
Status
Conditions
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.
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. To assess the feasibility, acceptability and implementation of new interventions designed to support a reduction in disease transmission, including testing strategies, we will recruit a small sub-sample of participants into a sub-studies that will assess implementation outcomes.
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
- To test the acceptability, feasibility and effectiveness of (i) new and existing diagnostic tests and testing strategies and (ii) new and existing intervention strategies (therapeutic, behavioural, social) to support early diagnosis and subsequently reduce transmission.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
Victoria
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Melbourne, Victoria, Australia, 3004
- The Macfarlane Burnet Institute for Medical Research and Public Health
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Melbourne, Victoria, Australia, 3050
- The Peter Doherty Institute for infection and immunity
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Community participants -
Exclusion Criteria:
Unable to provide consent -
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
18 months
|
|
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).
|
18 months
|
|
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.
|
18 months
|
|
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.
|
18 months
|
|
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.
|
18 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Collect data of positive COVID19 cases reported in study participant questionnaires.
Time Frame: 18 months
|
The COVID 19 data will be analysed to determine the cases reported and if there are social contacts nominated in the questionnaires showing any linkage of cases.
The social mixing patterns nominated of COVID19 cases, will be used to develop and refine mathematical models to improve precision and timeliness of dynamic transmission estimates.
|
18 months
|
|
Assess the effectiveness of government interventions to reduce COVID-19 transmission from questionnaire responses from cohort participants
Time Frame: 18 months
|
Including but not limited to the number/proportion of participants with accurate knowledge of government recommendations and the number/proportion of participants using COVID-19 prevention measures as recommended by the government.
|
18 months
|
|
To investigate new and alternative tests to diagnose COVID-19.
Time Frame: 18 months
|
Participants of the Optimise main study who are diagnosed with COVID-19 and their contacts will be invited to participate in a sub study of saliva testing compared with deep nasal/throat swab testing for the diagnosis of COVID-19 using RT-PCR
|
18 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202006
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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