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Status unknownNCT05323799Updated Oct 23, 2023

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

An observational study in COVID-19, sponsored by Macfarlane Burnet Institute for Medical Research and Public Health Ltd. Status unknown at 1 site in Australia. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-23.

Sponsored by Macfarlane Burnet Institute for Medical Research and Public Health Ltd · Observational

The sponsor has not verified this record recently (last verified Oct 2023), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,000
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

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:

  1. 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.
  2. To better understand, assess and monitor the unintended health, social and economic consequences of the government interventions to control COVID-19 transmission
  3. 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.
02

Conditions studied

  • COVID-19

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03

In context

COVID-19

7,774 studies on the registry are indexed under COVID-19; 482 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 260 across 3,188 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Macfarlane Burnet Institute for Medical Research and Public Health Ltd is the lead sponsor of 15 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Volunteer participants over the age of 18 years in Victoria, Australia

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Community participants

Exclusion criteria

Exclusion Criteria:

  • Unable to provide consent
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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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What researchers measure

Primary outcomes

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

    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

    Time frame: 18 months

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

    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.

    Time frame: 18 months

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

    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.

    Time frame: 18 months

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

    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

    Time frame: 18 months

  5. Measure of the efficacy of government interventions

    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

    Time frame: 18 months

Secondary outcomes

  1. Collect and collate empirical data of COVID19 cases, contacts and key vulnerable groups

    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.

    Time frame: 18 months

  2. Assess the effectiveness of government interventions to reduce COVID-19 transmission from questionnaire responses from cohort participants

    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.

    Time frame: 18 months

07

Study locations

1 site
  • The Macfarlane Burnet Institute for Medical Research and Public Health
    Melbourne, Victoria 3004, Australia
08

References and documents

Publications

  • Pedrana A, Bowring A, Heath K, Thomas AJ, Wilkinson A, Fletcher-Lartey S, Saich F, Munari S, Oliver J, Merner B, Altermatt A, Nguyen T, Nguyen L, Young K, Kerr P, Osborne D, Kwong EJL, Corona MV, Ke T, Zhang Y, Eisa L, Al-Qassas A, Malith D, Davis A, Gibbs L, Block K, Horyniak D, Wallace J, Power R, Vadasz D, Ryan R, Shearer F, Homer C, Collie A, Meagher N, Danchin M, Kaufman J, Wang P, Hassani A, Sadewo GRP, Robins G, Gallagher C, Matous P, Roden B, Karkavandi MA, Coutinho J, Broccatelli C, Koskinen J, Curtis S, Doyle JS, Geard N, Hill S, Coelho A, Scott N, Lusher D, Stoove MA, Gibney KB, Hellard M. Priority populations' experiences of isolation, quarantine and distancing for COVID-19: protocol for a longitudinal cohort study (Optimise Study). BMJ Open. 2024 Jan 12;14(1):e076907. doi: 10.1136/bmjopen-2023-076907. PubMed 38216183 ↗
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2020 (actual). Primary completion is estimated for Jun 2024, 45 months after the start.

Of 1,625 non-industry observational studies under COVID-19, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 29. This study's planned 45 months is above that.

Counting every sponsor, half of 1,750 studies reached it within 13 months; a quarter within 5 and three quarters within 29.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 6, 2022
First posted
Apr 12, 2022
StartActual
Sep 30, 2020
Primary completionEst.
Jun 30, 2024
CompletionEst.
Jun 30, 2024
Last update
Oct 23, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 23, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05323799
Lead sponsor
Macfarlane Burnet Institute for Medical Research and Public Health Ltd
Responsible party
Sponsor
First posted
Apr 12, 2022
Start date
Sep 30, 2020
Primary completion
Jun 30, 2024 (estimated)
Completion
Jun 30, 2024 (estimated)
Last update
Oct 23, 2023

Study contacts

Margaret Hellard
principal investigator · The Macfarlane Burnet Institute for Medical Research and Public Health

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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