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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05323799




Registration number
NCT05323799
Ethics application status
Date submitted
6/04/2022
Date registered
12/04/2022
Date last updated
23/10/2023

Titles & IDs
Public title
The Optimising Isolation, Quarantine and Distancing Study for COVID-19 (Optimise)
Scientific title
The Optimising Isolation, Quarantine and Distancing Study for COVID-19 (Optimise)
Secondary ID [1] 0 0
202007
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID-19 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Group 1/Seed set 1 - recently diagnosed 'COVID-19 cases - (Group1) 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

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
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from response in baseline questionnaires to Adherence (non-adherence) with COVID19 transmission containment measures
Timepoint [1] 0 0
18 months
Primary outcome [2] 0 0
Change from response in baseline questionnaires depicting what are the unintended health, social and economic consequences of the government response to control COVID19 transmission
Timepoint [2] 0 0
18 months
Primary outcome [3] 0 0
What are the social contacts and mixing patterns of COVID-19 cases
Timepoint [3] 0 0
18 months
Primary outcome [4] 0 0
What are the types of social contacts and mixing patterns of COVID-19 cases
Timepoint [4] 0 0
18 months
Primary outcome [5] 0 0
Measure of the efficacy of government interventions
Timepoint [5] 0 0
18 months
Secondary outcome [1] 0 0
Collect and collate empirical data of COVID19 cases, contacts and key vulnerable groups
Timepoint [1] 0 0
18 months
Secondary outcome [2] 0 0
Assess the effectiveness of government interventions to reduce COVID-19 transmission from questionnaire responses from cohort participants
Timepoint [2] 0 0
18 months

Eligibility
Key inclusion criteria
- Community participants
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Unable to provide consent

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/09/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/06/2024
Actual
Sample size
Target
1000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Macfarlane Burnet Institute for Medical Research and Public Health - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Macfarlane Burnet Institute for Medical Research and Public Health Ltd
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05323799
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Margaret Hellard
Address 0 0
The Macfarlane Burnet Institute for Medical Research and Public Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries