Exploration of the Italian response to COVID-19 pandemic
| ISRCTN | ISRCTN26200758 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN26200758 |
| ClinicalTrials.gov number | Nil Known |
- Submission date
- 01/04/2021
- Registration date
- 11/05/2021
- Last edited
- 14/06/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
The COVID-19 pandemic outbreak is placing an overwhelming burden on health systems and authorities to respond with effective and appropriate interventions, policies and messages. The pandemic and its restrictions may have affected mental and physical well-being, social cohesion, economic stability as well as individual and community resilience and trust.
In this complex context, understanding how, why and the context in which humans and communities respond allows to 1) anticipate unwanted scenarios and initiate mitigating measures; and 2) implement pandemic response measures that are better informed, situated, accepted and thus more effective.
This study is part of the large project promoted by the World Health Organization (WHO) called “Monitoring knowledge, risk perceptions, preventive behaviours and trust to inform pandemic outbreak response” and conducted in over 30 countries of the WHO European Region.
This is an observational study with voluntary participation in the general population, with expected low risk for participants. In Italy, the survey is conducting administering a questionnaire online developed ad hoc by the WHO in four waves (from January to May 2021) to a national representative sample of aged 18-70, stratified for different dimensions.
Who can participate?
General population 18-70 years old
What does the study involve?
Participants complete an online questionnaire.
What are the possible benefits and risks of participating?
Potential risks identified include only the inconvenience of the time taken to respond to the survey, and given the current restrictions people face, many individuals currently have more available time. Benefits include the sense of contributing and being able to participate in shaping the country’s pandemic response.
Where is the study run from?
IRCCS Istituto Centro San Giovanni di Dio, Fatebenefratelli (Italy)
When is the study starting and how long is it expected to run for?
October 2020 to September 2021
Who is funding the study?
The italian project has been funded by Fondazione Cariplo and IRCCS Istituto Centro San Giovanni di Dio, Fatebenefratelli (Italy)
Who is the main contact?
Giovanni de Girolamo, M.D., gdegirolamo@fatebenefratelli.eu
Contact information
Scientific
U.O. Psychiatric Epidemiology and Evaluation
IRCCS Istituto Centro San Giovanni di Dio, Fatebenefratelli
Via Pilastroni 4
Brescia
25125
Italy
 ORCID ID |
0000-0002-1611-8324 |
|---|---|
| Phone | +39 (0)303501590 |
| gdegirolamo@fatebenefratelli.eu |
Scientific
St John of God Clinical Research Centre
v. Pilastroni 4
Brescia
25121
Italy
| ORCID ID |
0000-0003-4062-7847 |
|---|---|
| Phone | +39 030 3501 333 |
| vcandini@fatebenefratelli.eu |
Scientific
St John of God Clinical Research Centre
v. Pilastroni 4
Brescia
25121
Italy
| ORCID ID |
0000-0002-6613-4445 |
|---|---|
| Phone | +39 030 3501 329 |
| czarbo@fatebenefratelli.eu |
Scientific
St John of God Clinical Research Centre
v. Pilastroni 4
Brescia
25121
Italy
| ORCID ID |
0000-0002-3339-3539 |
|---|---|
| Phone | +39 030 3501 333 |
| chiara.buizza@unibs.it |
Study information
| Study design | Observational cross sectional study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Internet/virtual |
| Study type | Other |
| Participant information sheet | https://www.euro.who.int/__data/assets/pdf_file/0007/436705/COVID-19-survey-tool-and-guidance.pdf |
| Scientific title | Monitoring knowledge, risk perceptions, preventive behaviours and trust to inform pandemic outbreak response - Italian study |
| Study acronym | COVID-WHO-ITALY |
| Study objectives | The study aims to gain insights into risk perception, knowledge, trusted sources of information, attitudes toward pandemic response initiatives and other variables to inform COVID-19 outbreak response measures, including policies, interventions and communications. The primary objectives are to: - Monitor variables that are critical for population behaviour to control transmission of the novel coronavirus, including risk perceptions, knowledge, self-efficacy, confidence in institutions, behaviours, rumours, affect, worry, resilience, trust in/use of information sources and more - Document changes over time in these factors to understand the effect of the pandemic process, new developments, events or measures taken - Monitor possible issues, e.g. related to misinformation or distrust, as they emerge, to allow early response - Identify relationships between variables to identify levers for effective and appropriate responses - Explore the relationship of psychological variables (e.g. worry, resilience, trust, affect) with the epidemiological situation and the events and measures taken - Identify gaps between perceived and actual knowledge - Evaluate the effectiveness of pandemic response measures, and the acceptance and effectiveness of policies and restrictions implemented, including the easing of such restrictions |
| Ethics approval(s) | Approved 03/12/2020, Ethical Committee of IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli (25125 BRESCIA – Via Pilastroni, 4, Italy; +39 303501586; ceioc@fatebenefratelli.it), ref: 286/2020 |
| Health condition(s) or problem(s) studied | Exploration of the Italian response to COVID-19 pandemic |
| Intervention | This study is part of a large project promoted by the World Health Organization (WHO) called “Monitoring knowledge, risk perceptions, preventive behaviours and trust to inform pandemic outbreak response” and conducted in over 30 countries of the WHO European Region. In Italy, the survey is conducted through a questionnaire online developed ad hoc by WHO; the questionnaire is being administered in four waves (January-May 2021) to a national representative sample of people aged 18-70. A detailed sampling plan was adopted to obtain a representative sample of the Italian adult population. The following variables were taken into account for the stratification of the participants: gender by age (4 age groups: 18-34 years, 35-44 years, 45-54 years, 55-70 years), geographical area (4 areas: North West, North East, Centre, South and Islands), size of living centers (2 classes: above and below 100,000 inhabitants), level of education (up to lower middle school, beyond lower middle school), and employment situation (employed, not employed). At the end of each survey’s wave, a weighting procedure is applied to accurately restore the proportionality of the total sample examined with the reference population, according to the most recent data of the Italian Statistics Institute (ISTAT). In particular, data are weighted for the main socio-demographic and geographic variables (e.g., sex, age, occupation, educational qualification, region and demographic size of the centers). |
| Intervention type | Other |
| Primary outcome measure | All measures have been collected in just one session (questionnaire administration), by means of a structured questionnaire developed ad hoc by WHO. Variables are measured using validated questions or adapted validated questions. The WHO questionnaire includes 21 different thematic areas noteworthy for the investigation of COVID-19 experience. The questionnaire was translated into Italian language, following the WHO’s guidelines for translations of tools into other languages. 1. Socio-demography. Items developed ad hoc including age, gender, education, medical background, chronic illness, rural/urban, district, household, financial situation (risk group identified as: 70+ years and/or chronic illness) 2. COVID-19 personal experience. Items developed ad hoc including COVID-19 infection (own, someone close) 3. Health literacy. Items adapted from: Sørensen K, Van den Broucke S, Pelikan JM, et al. (2013) and Griebler, Robert; Nitsche, Michael (2020) 4. COVID-19 risk perception: Probability and Severity. Validated items adapted from Brewer, N. T., Chapman, G. B., Gibbons, F. X., Gerrard, M., McCaul, K. D., & Weinstein, N. D. (2007) 5. Preparedness and Perceived self-efficacy. Psychological construct: preparedness -validated items adapted from: Bandura, A. (2006). Psychological construct: perceived self-efficacy - validated items adapted from: Renner, B., & Schwarzer, R. (2005) 6. Prevention – own behaviours. Items adapted from: Steel Fisher GK et al (2012) 7. Affect related to COVID-19. Validated items adapted from: Bradley, M. M., & Lang, P. J. (1994) 8. Trust in sources of information: Schweitzer, M. E., Hershey, J. C., & Bradlow, E. T. (2006) and Pearson, S. D., & Raeke, L. H. (2000) 9. Use of sources of information. Items developed ad hoc including use of information sources (television, newspapers, health workers, social media, radio, Ministry of Health, Institute of Public Health, hotlines, official website, celebrities) 10. Frequency of Information. Items developed ad hoc including frequency in information for different sources (television, newspapers, health workers, social media, radio, Ministry of Health, Institute of Public Health, hotlines, official website, celebrities) 11. Trust in institutions (perceptions): Schweitzer, M. E., Hershey, J. C., & Bradlow, E. T. (2006) and Pearson, S. D., & Raeke, L. H. (2000) 12. Policies, interventions (perceptions). Items developed ad hoc including Perceptions related to possible/real government policies (COVID-19 vaccine, discrimination behaviours, testing, exaggeration in restrictions, quarantine) 13. Conspiracies (perceptions). Validated items taken from: Bruder M, Haffke P, Neave N, Nouripanah N, Imhoff R. (2013) 14. Resilience (perceptions). Validated items taken from: Smith, B. W., Dalen, J., Wiggins, K., Tooley, E., Christopher, P., & Bernard, J. (2008) 15. Testing and tracing. Items grounded in theory: Michie et al (2014) 16. Fairness (perceptions). Validated items taken from: Gamliel, E., & Peer, E. (2010) 17. Lifting restrictions (pandemic transition phase). Items developed ad hoc including perceptions related to lifting restrictions (adapted to country decisions made/considered 18. Unwanted behaviour. Items developed ad hoc including reported own behaviour (discrimination, physical exercise, alcohol, diet, smoking, vaccination postponed, drugs against COVID-19, postponed doctor visit) 19. Well-being. Validated items from: WHO 5-item well-being scale (WHO-5) 20. COVID-19 vaccine. Items grounded in theory: Michie et al (2014) |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 01/10/2020 |
| Completion date | 21/05/2021 |
Eligibility
| Participant type(s) | Population |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 70 Years |
| Sex | Both |
| Target number of participants | 10,000 |
| Total final enrolment | 10013 |
| Key inclusion criteria | General population 18-70 years old |
| Key exclusion criteria | Current isolation due to COVID-19 infection |
| Date of first enrolment | 03/01/2021 |
| Date of final enrolment | 21/05/2021 |
Locations
Countries of recruitment
- Italy
Study participating centres
Brescia
25125
Italy
Modena
41124
Italy
Roma
00161
Italy
Sponsor information
Research organisation
IRCCS
Via Pilastroni 4
Brescia
25125
Italy
| Phone | +39 (0)3035011 |
|---|---|
| centro.sangiovanni.di.dio@fatebenefratelli.eu | |
| Website | https://www.fatebenefratelli.it/strutture/irccs-brescia |
"ROR" |
https://ror.org/02davtb12 |
Hospital/treatment centre
Dept of Mental Health
Via S Giovanni del Cantone 23
Modena
41121
Italy
| Phone | +39 (0)59435111 |
|---|---|
| f.starace@ausl.mo.it | |
| Website | http://www.ausl.mo.it/home |
|
"ROR" |
https://ror.org/0018xw886 |
Government
Viale Regina Elena 299
Rome
00161
Italy
| Phone | +39 0649901 |
|---|---|
| gemma.calamandrei@iss.it | |
| Website | http://www.iss.it |
|
"ROR" |
https://ror.org/02hssy432 |
Funders
Funder type
Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Cariplo Foundation
- Location
- Italy
No information available
Results and Publications
| Intention to publish date | 01/10/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in publicly available repository |
| Publication and dissemination plan | Planned publication in high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a publically available repository. (Zenodo, https://zenodo.org/); there will be a 2-year embargo, although it will always be possible to write to the coordinators to propose scientific collaborations based on this dataset. After the embargo, to obtain the dataset it will be necessary to write to the study coordinators. Raw data will be shared: all data are fully anonymised and it was obtained written permission from all study participants for the sharing of completely anonymised data for scientific purposed. This is also stated in the permission obtained from the Ethical Committee. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 26/10/2022 | 14/06/2023 | Yes | No | |
| Results article | 17/11/2022 | 14/06/2023 | Yes | No |
Editorial Notes
14/06/2023: Publication references added.
04/06/2021: The following changes were made to the trial record:
1. The overall end date was changed from 30/09/2021 to 21/05/2021.
2. The total final enrolment was added.
02/06/2021: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/06/2021 to 21/05/2021.
2. Three scientific contacts were added.
06/04/2021: Trial's existence confirmed by Ethical Committee of IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli.
