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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/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)
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Scientific title
The Optimising Isolation, Quarantine and Distancing Study for COVID-19 (Optimise)
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Secondary ID [1]
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202007
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
COVID-19
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Condition category
Condition code
Infection
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Other infectious diseases
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Respiratory
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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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
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change from response in baseline questionnaires to Adherence (non-adherence) with COVID19 transmission containment measures
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Assessment method [1]
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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
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Timepoint [1]
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18 months
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Primary outcome [2]
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Change from response in baseline questionnaires depicting what are the unintended health, social and economic consequences of the government response to control COVID19 transmission
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Assessment method [2]
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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.
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Timepoint [2]
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18 months
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Primary outcome [3]
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What are the social contacts and mixing patterns of COVID-19 cases
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Assessment method [3]
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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.
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Timepoint [3]
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18 months
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Primary outcome [4]
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What are the types of social contacts and mixing patterns of COVID-19 cases
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Assessment method [4]
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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
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Timepoint [4]
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18 months
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Primary outcome [5]
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Measure of the efficacy of government interventions
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Assessment method [5]
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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
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Timepoint [5]
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18 months
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Secondary outcome [1]
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Collect and collate empirical data of COVID19 cases, contacts and key vulnerable groups
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Assessment method [1]
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The researchers will integrate data from adherence outcomes, social contacts and transmission outcomes from diaries and questioners into key analyses; cross sectional social network models, structural equation modelling \& social network analyses.
Researchers will use empirical data regarding transmission dynamics, social contacts and mixing patterns of COVID19 cases, their contacts and key vulnerable groups to develop and refine mathematical models to improve precision and timeliness of dynamic transmission estimate.
The researchers will use social contacts and transmission outcomes to update deterministic compartmental epidemic model to estimate the effect of testing and surveillance on the spread of COVID-19 in Australia.
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Timepoint [1]
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18 months
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Secondary outcome [2]
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Assess the effectiveness of government interventions to reduce COVID-19 transmission from questionnaire responses from cohort participants
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Assessment method [2]
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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. The researchers will analyse adherence outcomes using serial cross-sectional approach to estimate a adherence level for participant groups of a) isolation, b) quarantine and c) physical distancing.
The researchers will assess changes in adherences over time within participant groups a) isolation, b) quarantine, using chi-square tests of proportions. The researchers will assess changes in adherence to government requirements within participant group c) physical distancing over time, using time to event analysis, such as proportional hazards tests or Cox regression.
Researchers are not using individual assessments for analyses.
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Timepoint [2]
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18 months
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Eligibility
Key inclusion criteria
* Community participants
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
* Unable to provide consent
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
30/09/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/06/2024
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Actual
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Sample size
Target
1000
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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The Macfarlane Burnet Institute for Medical Research and Public Health - Melbourne
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Recruitment postcode(s) [1]
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3004 - Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
Macfarlane Burnet Institute for Medical Research and Public Health Ltd
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/study/NCT05323799
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Margaret Hellard
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Address
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The Macfarlane Burnet Institute for Medical Research and Public Health
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05323799
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