Accuracy of the Association Between the "PA-R" and "ACT" Questionnaires in Asthmatic Pediatric Patients (QAS)

Study on the Accuracy of the Association Between the "Physical Activity-Rating" and "Asthma Control Test" Questionnaires in the Anamnestic Evaluation of Asthma Symptom Control in Pediatric Patients

A patient with asthma requires daily and long-term pharmacological treatment when symptoms are frequent and/or severe. International guidelines suggest increasing or reducing pharmacological therapy based on the individual's needs. On average, follow-up visits for a child with asthma treated with maintenance pharmacological therapy should be every 3 months. This period is often challenging to meet in clinical practice because of long waiting lists. An alternative solution could involve the use of structured questionnaires that the patient should fill out on their own (if aged 12 or older) or with the help of parents (if younger than 12). A similar solution is also suggested by international asthma guidelines. The doctor, upon receiving the questionnaire, for example through email, could make the appropriate management decisions and communicate them to the patient, again through email. For remote use, the test should have optimal sensitivity and specificity, otherwise, there is a risk of either underestimating or overestimating the need for adjustments to the maintenance therapy. The most commonly used is the Asthma Control Test (ACT), which did non demonstrate an elevated sensibility and specificity as revealed by different studies. Tripoli et al., for example, reported that 22% of children aged 12 or older with an ACT score = 25 have asthma and a fall in FEV1 >12% after physical exertion. Considering the information above, we considered combining the ACT with the Physical Activity-Rating (PA-R), a validated questionnaire for measuring the level of physical activity. It is possible that one of the issues lies in the lack of quantification of the patient's physical activity level when administering the ACT. Through an interventional study, our intention is to assess the diagnostic accuracy of the ACT + PA-R combination (test under experimentation) compared to ACT (traditional test) and compared to reference standard (spirometry before and after exertion). The goal of the study is to evaluate whether the combination of a high score in both the PA-R (>7) and ACT (>21) can accurately identify patients with well-controlled asthma, i.e., those with normal spirometry after physical exertion.

Study Overview

• Status: Not yet recruiting
• Conditions: Asthma in Children
• Intervention / Treatment: Procedure: Administration of the ACT + PA-R questionnaires; Procedure: ACT questionnaire

• Study Type: Interventional
• Enrollment (Estimated): 174
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stefano Miceli Sopo; Phone Number: +390630155701; Email: Stefano.MiceliSopo@unicatt.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Correctly diagnosed asthma;
• Age between 6 and 15 years;
• Understanding and signing of the informed consent by the parent/guardian;
• Understanding and signing of the assent by the minor.

Exclusion Criteria:

• Inability to correctly perform spirometry;
• Inability to correctly perform the exercise test;
• Unwillingness to sign the informed consent by the parent/guardian;
• Unwillingness to sign the assent by the minor.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Asthma Control Test (ACT) + PA-R; Association of "ACT + PA-R" questionnaires	Procedure: Administration of the ACT + PA-R questionnaires; The "ACT + PA-R" questionnaires will be administered to pediatric patients with a previously confirmed diagnosis of asthma, who attend the Pediatric Allergy Day Hospital for a routine check-up with spirometry before and after physical exertion.
Active Comparator: Asthma Control Test (ACT); ACT questionnaire	Procedure: ACT questionnaire; The "ACT" questionnaire will be administered to pediatric patients with a previously confirmed diagnosis of asthma, who attend the Pediatric Allergy Day Hospital for a routine check-up with spirometry before and after physical exertion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of the reliability of the single ACT test versus the combined test (ACT + PA-R)	One group of patients will be dministered the ACT test and one group the ACT + PAR test to compare the reliability between the two test and the reference standard (spirometry before and after physical exertion).	24 months

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Investigators: Principal Investigator: Stefano Miceli Sopo, Fondazione Policlinico Universitario A. Gemelli, IRCCS

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2025
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: February 14, 2025
• First Submitted That Met QC Criteria: February 19, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 19, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Asthma
• Other Study ID Numbers: 7190 (CTEP)

Drug and device information, study documents

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