"Studio NaVA" - National Study on Quality of Life in Adolescents Affected by Allergic Rhinitis With or Without Asthma

May 18, 2017 updated by: Stefania La Grutta, MD

Studio NaVA - Studio Nazionale Sulla Qualità Della Vita in Adolescenti Con Rinite Allergica Con e Senza Asma

"Studio Nava" is a National Study aiming to assess allergic rhinitis and asthma outcomes on Quality of Life and Quality of Sleep in adolescent patients by means of Web Survey. "Studio Nava" also proposes the innovative use of a web platform ("http://nava.ibim.cnr.it/") that contains all standardized tools (medical-healthcare web form, ACT, Asthma control test; PSQI, Pittsburgh Sleep Quality Index; T5SS, Total Symptom Score; modified SIDRIA for adolescents; Rhinasthma; VAS scale), that will be available for the doctors after the registration to the web platform. Downloaded questionnaires will be delivered to case-patient, asking him/her to fill them during the waiting time of the visit.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Palermo, Italy, 90146
        • Institute of Biomedicine and Molecular Immunology, IBIM
    • Sicily
      • Palermo, Sicily, Italy, 90146
        • Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

  • 600 adolescents with allergic rhinitis with/without asthma, from 14 to 17 years age, recruited from Pediatricians of the Italian territory
  • 600 subject (5 for each participant Pediatrician) of the same age range, without respiratory pathology (patient family)

Description

Inclusion Criteria:

  • Clinical cases n°: 600 adolescents affected by allergic rhinitis with/without asthma, from 14 to 17 years age.
  • Controls n°: 600 subject (5 for each participant Pediatrician) of the same age range, without respiratory pathology.

Exclusion Criteria:

  • Subjects that have not allergic rhinitis with/without asthma diagnosis or are <14 years old or >17 years old

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Allergic rhinitis with/without asthma, from 14 to 17 years age
600 adolescents with allergic rhinitis with/without asthma, from 14 to 17 years age, recruited from Pediatricians of the Italian territory.
Other: Data Collection
Without respiratory pathology
600 subject (5 for each participant Pediatrician) of the same age range, without respiratory pathology (patient family)
Other: Data Collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assessment of the allergic rhinitis impact on quality of life
Time Frame: 2 weeks
2 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
The impact of AR and asthma on quality of sleep
Time Frame: 2 weeks
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stefania La Grutta, MD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

February 27, 2015

First Submitted That Met QC Criteria

March 4, 2015

First Posted (Estimate)

March 5, 2015

Study Record Updates

Last Update Posted (Actual)

May 19, 2017

Last Update Submitted That Met QC Criteria

May 18, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Verbale n°13/2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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