Feasibility and success of cell-phone assisted remote observation of medication adherence (CAROMA) in clinical trials
Feasibility and success of cell-phone assisted remote observation of medication adherence (CAROMA) in clinical trials
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DOI：
10.1016/j.drugalcdep.2016.02.045
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发表时间：
2016-06-01
影响因子：
4.2
通讯作者：
D'Souza, Deepak Cyril
中科院分区：
文献类型：
--
作者：
DeWorsop, David;Creatura, Gina;D'Souza, Deepak Cyril
目的：药物不依从性在临床试验中是一个严重的问题，特别是在药物滥用障碍的研究中。衡量和确认遵从性是确保收集的数据准确和可解释的关键。这项研究评估了一种基于智能手机的方法(手机辅助的服药依从性远程观察ICAROMA])在临床试验中视觉确认服药依从性的可行性和成功。方法：在一项针对大麻依赖的双盲、随机、安慰剂对照试验中，通过向参与者提供智能手机来视觉确认服药依从性。每天早上，受试者(n=20)由观察研究药物消耗的工作人员进行视频通话。依从性也通过每周面对面的访问、药片数量和血浆药物水平进行评估。受试者完成每天的Caroma探视，并在研究完成时归还智能手机。结果：Caroma确认96.04%的人坚持服药。每周访问的预期和实际剩余研究用药之间的符合率为87.69%。被分配到积极研究药物的受试者有可检测到的血浆药物水平，而被分配到安慰剂组的受试者没有检测到。每名受试者每周的CAROMA费用估计约为100美元--在试验的3周门诊部分，每个受试者总共花费300.24美元。结论：这项先导性研究证明了CAROMA在临床试验中促进和确认用药依从性的可行性、成功和成本效益。初步发现支持更大规模和更长时间的研究，并可能将这种方法应用于临床护理，特别是在其他药物不依从率较高的人群中。(C)2016爱思唯尔爱尔兰有限公司。保留所有权利。
Objective: Medication nonadherence is a serious issue in clinical trials, especially in studies of substance abuse disorders. Measuring and confirming adherence is critical to ensuring that collected data is accurate and interpretable. This study evaluated the feasibility and success of a smartphone-based approach (Cell phone Assisted Remote Observation of Medication Adherence ICAROMA]) to visually confirm medication adherence in a clinical trial.Method: Medication adherence was confirmed visually via smartphones provided to participants in a double-blind, randomized, placebo-controlled trial for cannabis dependence. Every morning, subjects (n =20) were video-called by staff who observed consumption of study medication. Adherence was also assessed with weekly face-to-face visits, pill counts and plasma drug levels. Subjects were paid for completing daily CAROMA visits, and for returning the smartphone at study completion.Results: CAROMA confirmed 96.04% adherence to medication. Concordance between expected and actual remaining study medication counted at weekly study visits was 87.69%. Subjects assigned to active study medication had detectable plasma drug levels, while those assigned to placebo did not. CAROMA was estimated to cost approximately $100 per subject per week - a total of $300.24 per subject for the 3-week outpatient portion of the trial.Conclusion: This pilot study demonstrates the feasibility, success and cost-effectiveness of CAROMA to facilitate and confirm medication adherence in a clinical trial. Preliminary findings support larger and longer studies, and possibly applying this approach to clinical care especially in other populations with high rates of medication nonadherence. (c) 2016 Elsevier Ireland Ltd. All rights reserved.