NCT05186896

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 11, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2023

Completed
Last Updated

January 11, 2022

Status Verified

December 1, 2021

Enrollment Period

1.8 years

First QC Date

November 16, 2021

Last Update Submit

December 23, 2021

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (1)

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

Interventions

A questionnaire for risk perception will be developed and administered

Residents of areas at high risk of environmental crisis

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Individuals with learning difficulties.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)

Palermo, 90146, Italy

RECRUITING

Central Study Contacts

Stefania La Grutta, MD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Director

Study Record Dates

First Submitted

November 16, 2021

First Posted

January 11, 2022

Study Start

June 1, 2021

Primary Completion

March 3, 2023

Study Completion

March 3, 2023

Last Updated

January 11, 2022

Record last verified: 2021-12

Locations