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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05323799
• Other study ID #: 202007
• Status: Active, not recruiting
• Start date: September 30, 2020
• Est. completion date: June 30, 2024

Study information

• Verified date: October 2023
• Source: Macfarlane Burnet Institute for Medical Research and Public Health Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1000
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Community participants

Exclusion Criteria:

• Unable to provide consent

Related Conditions & MeSH terms

• COVID-19

Locations

Country	Name	City	State
Australia	The Macfarlane Burnet Institute for Medical Research and Public Health	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Macfarlane Burnet Institute for Medical Research and Public Health Ltd

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	18 months
Primary	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.	18 months
Primary	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.	18 months
Primary	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	18 months
Primary	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	18 months
Secondary	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.	18 months
Secondary	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.	18 months