AIM2ACT: Randomized controlled trial protocol for a mobile health intervention for early adolescents with asthma

Contemp Clin Trials. 2022 Dec:123:107011. doi: 10.1016/j.cct.2022.107011. Epub 2022 Nov 15.

Abstract

Early adolescents diagnosed with asthma have difficulties consistently performing disease self-management behaviors, placing them at-risk for poor asthma control, morbidity, and reduced quality of life. Helpful caregiver support is pivotal in determining whether early adolescents develop and master asthma self-management behaviors. We developed Applying Interactive Mobile health to Asthma Care in Teens (AIM2ACT), a mobile health intervention to facilitate helpful caregiver support in early adolescents (12-15 year-olds) with poorly controlled asthma. AIM2ACT is a dyadic smartphone intervention that contains three components: 1) ecological momentary assessment to identify personalized strengths and weaknesses in asthma self-management behaviors; 2) collaborative identification and tracking of goals that help early adolescents to become increasingly independent in managing their asthma; and 3) a suite of skills training videos. This paper describes our plans to test the efficacy of AIM2ACT and evaluate long-term maintenance of treatment effects in a fully powered randomized controlled trial with 160 early adolescents with poorly controlled persistent asthma, ages 12-15 years, and a caregiver. Families will be randomly assigned to receive AIM2ACT (n = 80) or a mHealth attention control condition (n = 80) that accounts for attention and novelty of a technology-based intervention for 6 months. Assessments will occur at baseline, post-intervention, and 3-, 6-, and 12-month follow-up time points. We will collect patient-reported and objectively monitored (e.g., spirometry, adherence) outcomes. Given the timing of the trial, a secondary exploratory goal is to evaluate the perceived impact of COVID-19 on family functioning and parental control of their adolescent's asthma in the context of our intervention.

Trial registration: ClinicalTrials.gov NCT04448002.

Keywords: Adolescent; Asthma; Mobile health; Mobile phone; Self-management.

Publication types

  • Clinical Trial Protocol
  • Research Support, N.I.H., Extramural

MeSH terms

  • Adolescent
  • Asthma* / therapy
  • COVID-19*
  • Child
  • Humans
  • Monitoring, Physiologic
  • Quality of Life
  • Randomized Controlled Trials as Topic
  • Telemedicine*

Associated data

  • ClinicalTrials.gov/NCT04448002