Risk PerceptionNCT05186896
NETTUNIT - Italy-Tunisia Cross-border Environmental network_2
An observational study of Risk Perception, run by Istituto per la Ricerca e l'Innovazione Biomedica at 1 site in Italy.
Trial summary
The study involves the development and validation of a questionnaire for risk perception to be administered to residents of areas declared to be at high risk of environmental crisis in the areas of Caltanissetta (Italy) and Tunis (Tunisia). The questionnaire will be administered twice, at baseline and after 1 month. Read more about this study
- Who is it for?
- Ages 20 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Risk Perception
- What is being tested?
- Risk perception questionnaire
- How many people
- 1,000 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2021to 3 Mar 2023
- 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 20 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals aged 20-90 years of both sex, living in the areas of Caltanissetta (Italy) and Tunis (Tunisia).
Who may be able to join
- Individuals aged 20-90 years of both sex, living in the areas of Caltanissetta (Italy) and Tunis (Tunisia).
Who cannot join
- Individuals with learning difficulties.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)
Palermo, 90146
Stefania La Grutta, MD, 0916809194, stefania.lagrutt@irib.cnr.it
About this study
The study involves the development and validation of a questionnaire for risk perception to be administered to residents of areas declared to be at high risk of environmental crisis in the areas of Caltanissetta (Italy) and Tunis (Tunisia). The questionnaire will be administered twice, at baseline and after 1 month.
- Conditions
- Risk Perception
- Being tested
- Risk perception questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risk perception questionnaireOther
A questionnaire for risk perception will be developed and administered
| Study group | Role | What they receive |
|---|---|---|
| Residents of areas at high risk of environmental crisis | 1000 adult males and females living in areas declared at high risk of environmental crisis in the areas of Caltanissetta (Italy) and Tunis (Tunisia). Receives: Other: Risk perception questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Construct validity of the questionnaire score at baseline administration
The ability of the questionnaire score at baseline to differentiate between sub-samples that are known or expected to differ
Measured: Baseline administration
Construct validity of the questionnaire score 1 month after the baseline administration
The ability of the questionnaire score 1 month after the baseline administration to differentiate between sub-samples that are known or expected to differ
Measured: 1 month after the baseline administration
Repeatability of the questionnaire score between the first (baseline) and second (1 month) administration
The extent to which the answer distribution will be similar between the two administrations
Measured: Baseline administration and 1 month after the baseline administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start1 Jun 2021
- Primary completion3 Mar 2023 (estimated)
- Study completion3 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Risk PerceptionStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto per la Ricerca e l'Innovazione Biomedica
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefania La Grutta, MD, Istituto per la Ricerca e l'Innovazione Biomedica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05186896
- Sponsor's protocol ID
- 03/2021_2
- Status last verified
- Dec 2021
- First submitted
- 16 Nov 2021
- Last updated
- 11 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NETTUNIT - Italy-Tunisia Cross-border Environmental network_2
- ClinicalTrials.gov ID
- NCT05186896
- Acronym / sponsor ID
- 03/2021_2
- Conditions
- Risk Perception
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Istituto per la Ricerca e l'Innovazione BiomedicaUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 3 Mar 2023 (estimated)
- Study completion
- 3 Mar 2023 (estimated)
- First posted
- 11 Jan 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 study involves the development and validation of a questionnaire for risk perception to be administered to residents of areas declared to be at high risk of environmental crisis in the areas of Caltanissetta (Italy) and Tunis (Tunisia). The questionnaire will be administered twice, at baseline and after 1 month.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Residents of areas at high risk of environmental crisis | – | Other: Risk perception questionnaire1000 adult males and females living in areas declared at high risk of environmental crisis in the areas of Caltanissetta (Italy) and Tunis (Tunisia). |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals aged 20-90 years of both sex, living in the areas of Caltanissetta (Italy) and Tunis (Tunisia).
Key inclusion criteria (1 listed)
- Individuals aged 20-90 years of both sex, living in the areas of Caltanissetta (Italy) and Tunis (Tunisia).
Key exclusion criteria (1 listed)
- Individuals with learning difficulties.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Risk perception questionnaireA questionnaire for risk perception will be developed and administered | Other | Residents of areas at high risk of environmental crisis |
Primary outcome
Construct validity of the questionnaire score at baseline administration
Time frame: Baseline administration
The ability of the questionnaire score at baseline to differentiate between sub-samples that are known or expected to differ
Construct validity of the questionnaire score 1 month after the baseline administration
Time frame: 1 month after the baseline administration
The ability of the questionnaire score 1 month after the baseline administration to differentiate between sub-samples that are known or expected to differ
Repeatability of the questionnaire score between the first (baseline) and second (1 month) administration
Time frame: Baseline administration and 1 month after the baseline administration
The extent to which the answer distribution will be similar between the two administrations
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
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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.
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 Risk Perception, run by Istituto per la Ricerca e l'Innovazione Biomedica at 1 site in Italy.
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 11 Jan 2022. 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 Italy. 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?
Contact Stefania La Grutta, MD (0916809194, stefania.lagrutta@irib.cnr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Construct validity of the questionnaire score at baseline administration (time frame: Baseline administration). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jan 2022.