Targeting quality of life in asthmatic children: The MyTEP pilot randomized trial

Quality of life (QoL) is an important outcome in the management of children with asthma. Mobile Health (m-Health) and Therapeutic Education Programs (TEPs) are increasingly recognized as essential components of pediatric asthma management to improve disease outcomes.

To evaluate the effect of an education program (MyTherapeutic Education Program, MyTEP) that couples multidisciplinary TEP intervention with an m-Health Program (mHP) in improving QoL in asthmatic children.

This single-center study employed a nonblinded randomized clinical trial design. Italian-speaking children (6-11 years) with mild-moderate asthma were eligible for participation. Participants were randomly paired 1:1 with a control group that received mHP (smartphone app) or an intervention group that received MyTEP (TEP plus a smartphone app). Patients were followed up for 3 months. Descriptive statistics, Least Square (LS) mean change and Generalized Linear Mixed model were used for analysis.

Fifty patients were enrolled. The Pediatric Asthma Quality of Life Questionnaire (PAQLQ) score improved in both MyTEP (p = 0.014) and mHP (p = 0.046) with the minimally clinically significant difference of ⩾0.5 points reached in 23% of MyTEP and in 16% of mHP. Changes in PAQLQ scores were significantly greater in MyTEP than in mHP (LS mean difference: 0.269 p = 0.05). PAQLQ score was: positively associated with MyTEP (p = 0.023) and study time (p = 0.002); and inversely associated with current passive smoke exposure (p = 0.003).

Despite the small sample size and short observation period, this study demonstrated that implementing a multidisciplinary TEP with an m-Health program results in gains in QoL of children with asthma.