Evaluating a tele-asthma self-management intervention, Canadian Asthma Text Messaging Study (CANATEXTS), among adults with asthma: study protocol for a pragmatic randomized controlled trial

Abstract Background: While effective treatments are available, asthma control is suboptimal for many asthma patients. To help patients self-manage their asthma symptoms, provision of an asthma action plan (AAP), with instructions on managing worsening asthma symptoms is recommended, as a standard of care; however, only about half of patients correctly adhere to their AAP. Canadian Asthma Text Messaging (CANATEXTS) is a TH intervention facilitating access to an electronic AAP (eAAP) via a mobile device. In a feasibility study to assess the safety and efficacy of CANATEXTS, an 18% reduction in the relative risk of exacerbation was observed among the intervention group compared to control group. This study will assess the effectiveness of CANATEXTS on asthma outcomes in a Canada-wide study. Methods: This is a superiority a 2-arm, multisite randomized control trial (RCT). This study aims to determine if CANATEXTS reduces asthma exacerbations over a 12-month period, improves asthma control, QoL and medication adherence, and is cost-effective. The intervention includes access to an electronic asthma action plan (eAAP) on patients’ mobile devices, disease-related education, and weekly reminders via an SMS interface. The study will include 600 adult participants with asthma recruited from 14 respiratory clinics across Canada. Participants will be randomly assigned to either Intervention (eAAP) or Control (wAAP) groups. All outcomes of interest will be assessed during three in-person assessments (baseline, 6-month, and 12-month) and two telephone follow-ups (3-month and 9-month). Data will be analyzed with a linear mixed-effects model across all time points. Discussion: TH has the potential to improve adult individuals with asthma's engagement in self-management practices. Our feasibility study showed TH could yield a reduction in asthma exacerbations. If the proposed TH intervention is found to be effective for asthma management in a nation-wide trial, it will generate evidence to support integration of TH in asthma self-management. This study will also provide important information on the cost-effectiveness of CANATEXTS. Trial registration: ClinicalTrials.gov identifier: NCT02017795; date of registration: 06 May 2018 (registered prospectively)