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

NCT02380495 | Completed

• 1 other identifier: Verbale n°13/2013
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 2

Brief Summary

"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.

Conditions

Allergic Rhinitis; Asthma

Keywords

Adolescents; Respiratory Pathology

Outcome Measures

Primary Outcomes (1)

• Assessment of the allergic rhinitis impact on quality of life

  2 weeks

Secondary Outcomes (1)

• The impact of AR and asthma on quality of sleep

  2 weeks

Study Arms (2)

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

Interventions

Data Collection OTHER

Allergic rhinitis with/without asthma, from 14 to 17 years age; Without respiratory pathology

Eligibility Criteria

• Age: 14 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Stefania La Grutta, MD: lead

Study Sites (2)

Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council

Palermo, Sicily, 90146, Italy

Location

Institute of Biomedicine and Molecular Immunology, IBIM

Palermo, 90146, Italy

Location

MeSH Terms

Conditions

Rhinitis, Allergic; Asthma

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Lung Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD. Senior Researcher. Coordinator of Pediatric Allergy and Asthma Research Group. Institute of Biomedicine and Molecular Immunology, IBIM, National Research Council of Palermo, Italy.

Study Record Dates

• First Submitted: February 27, 2015
• First Posted: March 5, 2015
• Study Start: March 1, 2015
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: May 19, 2017

Record last verified: 2017-05

Locations

IT (2)