使用移动健康技术为高危哮喘儿童量身定制药物依从性激励措施（TAICAM）：一项随机对照试验的方案
Tailored Medication Adherence Incentives Using mHealth for Children With High-Risk Asthma (TAICAM): Protocol for a Randomized Controlled Trial.
作者信息
Henderson Brittney R, Flaherty Carina M, Floyd G Chandler, You Jack, Xiao Rui, Bryant-Stephens Tyra C, Miller Victoria A, Feudtner Chris, Kenyon Chén Collin
机构信息
Roberts Center for Pediatric Research, Children's Hospital of Philadelphia, Philadelphia, PA, United States.
Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, PA, United States.
出版信息
JMIR Res Protoc. 2020 Aug 17;9(8):e16711. doi: 10.2196/16711.
BACKGROUND
Poor adherence to inhaled corticosteroid medications for children with high-risk asthma is both well documented and poorly understood. It has a disproportionate prevalence and impact on children of minority demographics in urban settings. Financial incentives have been shown to be a compelling method to engage those in a high-risk asthma population, but whether adherence can be maintained by offering financial incentives and how these incentives can be used to sustain high adherence are unknown.
OBJECTIVE
The aim of this study is to determine the marginal effects of a financial incentive-based intervention on inhaled corticosteroid adherence, health care system use, and costs.
METHODS
Participants include children aged 5 to 12 years who have had either at least two hospitalizations or one hospitalization and one emergency department visit for asthma in the year prior to their enrollment (and their caregivers). Participants are given an electronic inhaler sensor in order to track their medication use over a period of 7 months. After a 1-month period of observation, participants are randomized to 1 of 3 arms for a 3-month period. Participants in arm 1 receive daily text message reminders, feedback, and gain-framed, nominal financial incentives; participants in arm 2 receive daily text message reminders and feedback only, and participants in arm 3 receive no reminders, feedback, or incentives. All participants are subsequently observed for an additional 3-month period with no reminders, feedback, or incentives to assess whether any sustained effects are apparent.
RESULTS
Study enrollment began in September 2019 with a target sample size of N=125 children. As of June 2020, 61 children have been enrolled. Data collection is estimated to be completed in June 2022, and analyses will be completed by June 2023.
CONCLUSIONS
This study will provide data that will help to determine whether a financial incentive-based mobile health intervention for promoting inhaled corticosteroid use can be effective in patients with high-risk asthma over longer periods.
TRIAL REGISTRATION
Clinicaltrial.gov NCT03907410; https://clinicaltrials.gov/ct2/show/NCT03907410.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/16711.
背景
高危哮喘儿童对吸入性糖皮质激素药物的依从性差，这一点已有充分记录，但人们对此了解不足。在城市环境中，这种情况在少数族裔儿童中的患病率和影响尤为突出。经济激励已被证明是促使高危哮喘人群参与治疗的一种有效方法，但通过提供经济激励能否维持依从性以及如何利用这些激励措施来保持高依从性尚不清楚。
目的
本研究的目的是确定基于经济激励的干预措施对吸入性糖皮质激素依从性、医疗保健系统使用情况和成本的边际效应。
方法
参与者包括年龄在5至12岁之间、在入组前一年因哮喘至少住院两次或住院一次且有一次急诊就诊经历的儿童（及其照顾者）。为参与者提供电子吸入器传感器，以跟踪他们在7个月内的用药情况。经过1个月的观察期后，参与者被随机分为3组中的1组，为期3个月。第1组的参与者每天收到短信提醒、反馈以及正向框架的小额经济激励；第2组的参与者仅每天收到短信提醒和反馈，第3组的参与者不接受任何提醒、反馈或激励。随后，所有参与者在没有提醒、反馈或激励的情况下再接受3个月的观察，以评估是否有任何持续影响。
结果
研究于2019年9月开始，目标样本量为N = 125名儿童。截至2020年6月，已招募61名儿童。数据收集预计于2022年6月完成，分析将于2023年6月完成。
结论
本研究将提供数据，有助于确定基于经济激励的移动健康干预措施在促进高危哮喘患者长期使用吸入性糖皮质激素方面是否有效。
试验注册
Clinicaltrial.gov NCT03907410；https://clinicaltrials.gov/ct2/show/NCT03907410。
国际注册报告识别码（IRRID）：DERR1-10.2196/16711。
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