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临床试验/NCT06844266
NCT06844266尚未招募不适用

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

Fondazione Policlinico Universitario Agostino Gemelli IRCCS0 个研究点目标入组 174 人开始时间: 2025年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
174
主要终点
Comparison of the reliability of the single ACT test versus the combined test (ACT + PA-R)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
6 Years 至 15 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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.

研究组 & 干预措施

Asthma Control Test (ACT) + PA-R

Experimental

Association of "ACT + PA-R" questionnaires

干预措施: Administration of the ACT + PA-R questionnaires (Procedure)

Asthma Control Test (ACT)

Active Comparator

ACT questionnaire

干预措施: ACT questionnaire (Procedure)

结局指标

主要结局

Comparison of the reliability of the single ACT test versus the combined test (ACT + PA-R)

时间窗: 24 months

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).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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