Mobile phones support adherence and retention of indigenous participants in a randomised controlled trial: strategies and lessons learnt

BMC Public Health

Anne B Chang⁴  Heather A D’Antoine²  Andrew V White¹  Nerida J Jacobsen¹  Clare C Mckay²  Peter S Morris³  Lesley A Versteegh²  Gabrielle B McCallum² 

[1] Department of Paediatrics, The Townsville Hospital, Townsville, Queensland, Australia;Child Health Division, Menzies School of Health Research, Charles Darwin University, Darwin, Northern Territory, Australia;Department of Paediatrics, Royal Darwin Hospital, Darwin, Northern Territory, Australia;Queensland Children’s Respiratory Centre, Queensland Children’s Medical Research Institute, Royal Children’s Hospital, Brisbane, Queensland, Australia

关键词: Indigenous;    Bronchiolitis;    ALRTI;    Randomised controlled trial;    Adherence;    SMS;    Mobile phones;   

Others  :  1129188
DOI  :  10.1186/1471-2458-14-622

 received in 2013-10-02, accepted in 2014-06-12,  发布年份 2014

【 摘 要 】

Background

Ensuring 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.

Methods

This 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.

Results

Of 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.

Conclusions

In 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 registration

ACTRN12608000150347 (RCT component).

【 授权许可】

   
2014 McCallum et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

Figure 2.

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