NETTUNIT - Italy-Tunisia Cross-border Environmental network_2

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 Overview

• Status: Recruiting
• Conditions: Risk Perception
• Intervention / Treatment: Other: Risk perception questionnaire

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Stefania La Grutta, MD; Phone Number: 0916809194; Email: stefania.lagrutta@irib.cnr.it

Study Locations

• Italy
  • Palermo, Italy, 90146
    • Recruiting
    • Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)
    • Contact: Stefania La Grutta, MD; Phone Number: 0916809194; Email: stefania.lagrutt@irib.cnr.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Individuals aged 20-90 years of both sex, living in the areas of Caltanissetta (Italy) and Tunis (Tunisia).

Description

Inclusion Criteria:

• Individuals aged 20-90 years of both sex, living in the areas of Caltanissetta (Italy) and Tunis (Tunisia).

Exclusion Criteria:

• Individuals with learning difficulties.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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).	Other: Risk perception questionnaire; A questionnaire for risk perception will be developed and administered

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	Baseline administration and 1 month after the baseline administration

Collaborators and Investigators

• Sponsor: Istituto per la Ricerca e l'Innovazione Biomedica

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Anticipated): March 3, 2023
• Study Completion (Anticipated): March 3, 2023

Study Registration Dates

• First Submitted: November 16, 2021
• First Submitted That Met QC Criteria: December 23, 2021
• First Posted (Actual): January 11, 2022

Study Record Updates

• Last Update Posted (Actual): January 11, 2022
• Last Update Submitted That Met QC Criteria: December 23, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 03/2021_2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No