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

NCT05323799 | Unknown DMC

• 1 other identifier: 202007
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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 Outcomes (2)

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

  18 months

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

  18 months

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Community participants

You may not qualify if:

• Unable to provide consent

Sponsors & Collaborators

• Macfarlane Burnet Institute for Medical Research and Public Health Ltd: lead

Study Sites (1)

The Macfarlane Burnet Institute for Medical Research and Public Health

Melbourne, Victoria, 3004, Australia

Location

Related Publications (1)

• 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.

  PMID: 38216183 DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Margaret Hellard

  The Macfarlane Burnet Institute for Medical Research and Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2022
• First Posted: April 12, 2022
• Study Start: September 30, 2020
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: October 23, 2023

Record last verified: 2023-10

Locations

AU (1)