Effectiveness and implementation of a multi-faceted intervention to facilitate adoption of asthma self-management practices in Peruvian children and adolescents: a hybrid type 2 individually randomized controlled trial.

Background: Peru has one of the highest burdens of asthma in the world, as well as large gaps in access to evidence-based treatments. Studies often overlook the ways in which the research context and data collection activities interact and influence the experience of a research participant, their perception of an intervention, and, by extension, study outcomes. Methods: We conducted an individually randomized type 2 hybrid-implementation trial to evaluate the implementation and effectiveness of a locally adapted, multi-faceted intervention package to improve adherence to self-management practices. We enrolled 110 children with physician-diagnosed asthma living in nine urban districts Lima, Peru, and followed them monthly for 6 months. 101 children completed the study. Participants in the intervention group received case management from a designated nurse manager, who provided ongoing educational, social, and self-management support in the form of follow-up home visits and phone-based communication. Long-term inhaler therapy was provided free of charge to both the intervention and control groups. We measured clinical effectiveness and implementation outcomes, guided by the Reach, Effectiveness, Adoption, Implementation, Maintenance framework. Results: Overall, both arms of the study saw improvements in asthma control, adherence, child- and caregiver- quality of life, and caregiver depressive symptoms, with the greatest improvement occurring between baseline and 1 month follow-up. However, there were no statistical differences in these outcomes between intervention and control arms at 6 months. Most caregivers in both arms perceived an improvement in asthma control and wellbeing. Caregivers and nurse managers found the intervention acceptable. Our results suggest that data collection activities involving regular check-ins regarding asthma symptoms and quality of life, as well as medication provision, may have contributed to improvements in clinical outcomes in both arms and partially explain the null results between arms. Discussion: Our study highlights the need for structural solutions, particularly around medication availability and affordability, for improving asthma management in these contexts. Our study design and analytical approach allowed us to identify underlying mechanisms that contributed to improvements in both study arms, despite the absence of a statistically significant effect in the primary outcome analysis. Work clearly accessible to a broad readership. Clinical trial registration: ClinicalTrials.gov, https://clinicaltrials.gov/study/NCT03986177.