Task-shifting to improve asthma management in Malawi: a randomised controlled trial

Background
Shortages of clinical staff make chronic asthma care challenging in low-income countries. We evaluated an outpatient asthma care package for children, including task-shifting of asthma education roles.
Methods
We conducted a non-blinded individually randomised controlled trial at a tertiary-level government hospital in Blantyre, Malawi. Children aged 6-15 years, diagnosed with asthma were recruited from outpatient clinic, stratified by Childhood Asthma Control Test (cACT) score, and allocated 1:1 from a concealed file, accessed during electronic questionnaire completion. The intervention comprised; clinical assessment, optimisation of inhaled treatment, individualised asthma education delivered by non-clinical staff. The control group received standard care from outpatient clinic staff. Primary outcome for intention-to-treat analysis was change in cACT score at 3-months. Secondary outcomes included asthma exacerbations requiring emergency health care, school absence, lung function and exhaled nitric oxide (FeNO).
Registration: Pan African Clinical Trials Registry: PACTR201807211617031
Study protocol: https://doi.org/10.1101/2020.08.12.20173401

Description of data
Baseline data was collected for all 120 children at the time of recruitment.
115 children attended the 3-month follow-up visit; questionnaire data are available for 114 children, spirometry for 114, and FeNO for 112.
Baseline data includes: asthma exacerbations (hospital admissions, health care facility attendances, school absence), asthma control (cACT, GINA questions [Global Initiave for Asthma]), ISAAC [International Study of Asthma and Allergy in Childhood] questions, asthma treatment, potential risk factors (triggers and exposures, family history, birth history, other medical conditions).
3-month outcome data includes: asthma exacerbations (hospital admissions, health care facility attendances, school absence), asthma control (cACT, GINA), asthma treatment, FeNO levels, pre- and post-bronchodilator spirometry.