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

NCT06844266 | Not Yet Recruiting

• 1 other identifier: 7190
• Study Type: interventional
• Target: 174
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Asthma in Children

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Asthma Control Test (ACT) + PA-R

EXPERIMENTAL

Association of "ACT + PA-R" questionnaires

Procedure: Administration of the ACT + PA-R questionnaires

Asthma Control Test (ACT)

ACTIVE COMPARATOR

ACT questionnaire

Procedure: ACT questionnaire

Interventions

Administration of the ACT + PA-R questionnaires PROCEDURE

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.

Asthma Control Test (ACT) + PA-R

ACT questionnaire PROCEDURE

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.

Asthma Control Test (ACT)

Eligibility Criteria

• Age: 6 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Officials

• Stefano Miceli Sopo

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefano Miceli Sopo

CONTACT

+390630155701; Stefano.MiceliSopo@unicatt.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2025
• First Posted: February 25, 2025
• Study Start: March 1, 2025
• Primary Completion: August 1, 2025
• Study Completion: January 1, 2026
• Last Updated: February 25, 2025

Record last verified: 2025-01