Patient-centered mobile tuberculosis treatment support tools (TB-TSTs) to improve treatment adherence: A pilot randomized controlled trial exploring feasibility, acceptability and refinement needs.
Patient-centered mobile tuberculosis treatment support tools (TB-TSTs) to improve treatment adherence: A pilot randomized controlled trial exploring feasibility, acceptability and refinement needs.
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以患者为中心的移动结核病治疗支持工具（TB-TST），以提高治疗依从性：一项探索可行性、可接受性和改进需求的随机对照试验。
DOI：
10.1016/j.lana.2022.100291
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发表时间：
2022
期刊：
影响因子：
--
通讯作者：
Demiris,
中科院分区：
文献类型：
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作者：
Iribarren,SarahJ;Milligan,Hannah;Chirico,Cristina;Goodwin,Kyle;Schnall,Rebecca;Telles,Hugo;Iannizzotto,Alejandra;Sanjurjo,Myrian;Lutz,BarryR;Pike,Kenneth;Rubinstein,Fernando;Rhodehamel,Marcus;Leon,Daniel;Keyes,Jesse;Demiris,
背景数字依从性技术有望改善以患者为中心的结核病（TB）监测，但很少有研究证实直接依从性监测或评估患者使用这些技术的经验。我们探讨了结核病治疗支持工具（TB-TSTs）干预的可接受性，可行性和细化需求，将移动的应用程序，尿液药物代谢物检测，以及与治疗supports.MethodsThis的互动沟通，试点研究是一个平行设计的单中心随机对照试验与退出访谈。来自阿根廷布宜诺斯艾利斯省呼吸内科医院的新诊断TB患者使用预加载有随机分配序列的REDCap软件中的治疗分配按钮以1：1的比例随机分配至常规护理或常规护理加TB-TSTs干预，并随访6个月。由于干预的性质，招募人员或患者无法对组分配设盲。治疗结果数据提取器对参与者的组分配不知情。干预参与者使用该应用程序报告自我管理的药物，潜在的副作用，提交尿检照片，并与治疗支持者互动。结果的可行性，可接受性，和治疗outcomes. FindingsForty 2例患者参加，平均分配到每组。干预参与者提交了147.2 ±58（平均值，SD）次自我给药和144.5 ±55次副作用报告（共180次）和47.5± 38.4张尿检照片（共77张）。常规护理的治疗成功率为81% [17/21]，TB-TSTs干预的治疗成功率为95% [20/21]。从访谈中确定了33个主题，主要类别包括动机、工作内容、经历的问题和建议。参与者（n=12）将其评为“易于使用”（4.57/5），“强烈推荐给其他人”（4.43/5），并报告获得治疗支持是一个关键组成部分。建议包括增加警报，预约提醒，和离线function.InterpretationFindings表明，TB-TSTs干预是可行的和可接受的，进一步的完善和测试是必要的。ClinicalTrials.gov标识符：NCT 03544476。
BackgroundDigital adherence technologies hold promise to improve patient-centered tuberculosis (TB) monitoring, yet few studies have incorporateddirectadherence monitoring or assessed patients' experiences with these technologies. We explored acceptability, feasibility, and refinement needs of the TB Treatment Support Tools (TB-TSTs) intervention linking a mobile app, a urine drug metabolite test, and interactive communication with a treatment supporter.MethodsThis pilot study was a parallel-designed single-center randomized controlled trial with exit interviews. Newly diagnosed TB patients from a respiratory medicine hospital in the province of Buenos Aires, Argentina were randomized 1:1 using a treatment allocation button in the REDCap software preloaded with a random allocation sequence to usual care or usual care plus the TB-TSTs intervention and followed for 6-months. Due to the nature of the intervention, blinding to the group allocation could not be achieved for the recruiter or patients. The treatment outcome data extractor was blinded to the group allocation of the participants. Intervention participants used the app to report self-administering medication, potential side effects, submit photos of the urine test, and interact with a treatment supporter. Outcomes were feasibility, acceptability, and treatment outcomes.FindingsForty-two patients were enrolled and evenly assigned to each group. Intervention participants submitted 147·2±58 (mean, SD) medication self-administration and 144·5±55 side effect reports out of 180 and 47.5±38·4 photos of the urine test out of 77. Treatment success for usual care was 81% [17/21] and 95% [20/21] for the TB-TSTs intervention. Thirty-three themes were identified from the interviews within the main categories of motivation, what worked, issues experienced, and recommendations. Participants (n=12) rated it as ‘easy to use' (4.57/5), ‘would highly recommend to others' (4·43/5) and reported that access to the treatment support was a critical component. Recommendations included adding an alarm, appointment reminders, and off-line functionality.InterpretationFindings suggest that the TB-TSTs intervention was feasible and acceptable and further refinement and testing is warranted.FundingNational Institute of Health K23NR017210. ClinicalTrials.gov Identifier: NCT03544476.