Abstract
BackgroundEnsuring adherence to treatment and retention is important in clinical trials, particularly in remote areas and minority groups. We describe a novel approach to improve adherence, retention and clinical review rates of Indigenous children.MethodsThis descriptive study was nested within a placebo-controlled, randomised trial (RCT) on weekly azithromycin (or placebo) for 3-weeks. Indigenous children aged ≤24-months hospitalised with acute bronchiolitis were recruited from two tertiary hospitals in northern Australia (Darwin and Townsville). Using mobile phones embedded within a culturally-sensitive approach and framework, we report our strategies used and results obtained. Our main outcome measure was rates of adherence to medications, retention in the RCT and self-presentation (with child) to clinic for a clinical review on day-21.ResultsOf 301 eligible children, 76 (21%) families declined participation and 39 (13%) did not have access to a mobile phone. 186 Indigenous children were randomised and received dose one under supervision in hospital. Subsequently, 182 (99%) children received dose two (day-7), 169 (93%) dose three (day-14) and 180 (97%) attended their clinical review (day-21). A median of 2 calls (IQR 1–3) were needed to verify adherence. Importantly, over 97% of children remained in the RCT until their clinical endpoint at day-21.ConclusionsIn our setting, the use of mobile phones within an Indigenous-appropriate framework has been an effective strategy to support a clinical trial involving Australian Indigenous children in urban and remote Australia. Further research is required to explore other applications of this approach, including the impact on clinical outcomes.Trial registrationACTRN12608000150347 (RCT component).
Highlights
Ensuring adherence to treatment and retention is important in clinical trials, in remote areas and minority groups
We report on a novel approach to improve adherence, retention and clinical follow-up post-hospitalisation in 186 Australian Indigenous children participating in a Randomised controlled trial (RCT)
The RCT examines the question: ‘amongst children hospitalised with acute bronchiolitis, does azithromycin given once/week for three doses improve clinical outcomes?’ For this study, we describe the cohort of children enrolled in this RCT, strategies used and results obtained in ensuring adherence, retention and presentation to the clinic for follow-up
Summary
Ensuring adherence to treatment and retention is important in clinical trials, in remote areas and minority groups. We describe a novel approach to improve adherence, retention and clinical review rates of Indigenous children. In the Northern Territory (NT), Indigenous children have high hospitalisation rates of bronchiolitis (352 per 1000) and more severe disease. Most children admitted are retrieved from remote communities [1,2]. Mobile phones offer the advantage of real time communication, do not require high skills to function, are accessible, affordable and not restricted to computer or land line access [8]. Data on SMS outcomes in paediatric conditions; [13] i.e. acute illnesses, Indigenous populations or remote areas are limited
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