COVID-19NCT05323799
The Optimising Isolation, Quarantine and Distancing Study for COVID-19 (Optimise)
An observational study of COVID-19, run by Macfarlane Burnet Institute for Medical Research and Public Health Ltd at 1 site in Australia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- How many people
- 1,000 participants
- Where
- 1 siteAustralia
- Study dates
- 30 Sep 2020to 30 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Volunteer participants over the age of 18 years in Victoria, Australia
Who may be able to join
- Community participants
Who cannot join
- Unable to provide consent
Trial locations and contacts
1 site in 1 country.
Australia1 site
The Macfarlane Burnet Institute for Medical Research and Public Health
Melbourne, Victoria, 3004
About this study
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:
- 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.
- Conditions
- COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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.
Measured: 18 months
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.
Measured: 18 months
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
Measured: 18 months
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
Measured: 18 months
Secondary outcomes (2)
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.
Measured: 18 months
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.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study start30 Sep 2020
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Macfarlane Burnet Institute for Medical Research and Public Health Ltd
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Margaret Hellard, Principal investigator, The Macfarlane Burnet Institute for Medical Research and Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05323799
- Sponsor's protocol ID
- 202007
- Status last verified
- Oct 2023
- First submitted
- 6 Apr 2022
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Optimising Isolation, Quarantine and Distancing Study for COVID-19 (Optimise)
- ClinicalTrials.gov ID
- NCT05323799
- Acronym / sponsor ID
- 202007
- Conditions
- COVID-19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Macfarlane Burnet Institute for Medical Research and Public Health LtdUniversity, hospital or other
- Study start
- 30 Sep 2020 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 12 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Volunteer participants over the age of 18 years in Victoria, Australia
Key inclusion criteria (1 listed)
- Community participants
Key exclusion criteria (1 listed)
- Unable to provide consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change from response in baseline questionnaires to Adherence (non-adherence) with COVID19 transmission containment measures
Time frame: 18 months
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
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
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.
What are the social contacts and mixing patterns of COVID-19 cases
Time frame: 18 months
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.
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
Measure of the efficacy of government interventions
Time frame: 18 months
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
2 secondary outcomes
Collect and collate empirical data of COVID19 cases, contacts and key vulnerable groups
Time frame: 18 months
Assess the effectiveness of government interventions to reduce COVID-19 transmission from questionnaire responses from cohort participants
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Derived from this study: PubMed 38216183Pedrana 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margaret Hellard principal investigator
The Macfarlane Burnet Institute for Medical Research and Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Macfarlane Burnet Institute for Medical Research and Public Health Ltd at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from response in baseline questionnaires to Adherence (non-adherence) with COVID19 transmission containment measures (time frame: 18 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05323799, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.