Patient randomised controlled trial of technology enabled strategies to promote treatment adherence in liver transplantation: rationale and design of the TEST trial.
Patient randomised controlled trial of technology enabled strategies to promote treatment adherence in liver transplantation: rationale and design of the TEST trial.
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技术的随机对照试验实现了策略，以促进肝移植中的治疗依从性：测试试验的基本原理和设计。
DOI：
10.1136/bmjopen-2023-075172
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发表时间：
2023-09-18
期刊：
影响因子：
2.9
通讯作者：
中科院分区：
文献类型：
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作者：
肝移植是终末期肝病的一种挽救生命的手术。然而，移植后的药物治疗方案是复杂的，不遵守是常见的。移植后药物不依从与移植物排斥相关，这可能会产生长期不良后果。移植中心配备了监测移植后患者的临床工作人员;然而，数字健康工具和主动免疫抑制依从性监测有可能改善结果。这是一项在美国东北部、中西部和南部的三个移植中心进行的患者随机前瞻性临床试验，旨在研究远程管理依从性方案与常规护理相比的效果。该计划主要通过勒韦林提示来监测潜在的不遵守行为，并将不遵守行为的性质表现为认知、心理、医学、社会或经济。还包含额外的药物提醒、临床预约和常规自我管理支持，以促进对整个医疗方案的遵守。主要研究结局是通过24小时回忆的药物依从性;次要结局包括其他药物依从性（ASK-12自我报告量表、方案知识量表、他克莫司值）、生活质量、功能健康状态和临床结局（例如，住院天数）。还将评价研究实施、可接受性、可行性、成本和潜在成本效益。宾夕法尼亚大学审查委员会已批准本研究作为单一IRB记录（方案编号849575，V.1.4）。结果将发表在同行评审的期刊上，并将摘要提供给研究资助者。NCT 05260268。
Liver transplantation is a life-saving procedure for end-stage liver disease. However, post-transplant medication regimens are complex and non-adherence is common. Post-transplant medication non-adherence is associated with graft rejection, which can have long-term adverse consequences. Transplant centres are equipped with clinical staff that monitor patients post-transplant; however, digital health tools and proactive immunosuppression adherence monitoring has potential to improve outcomes. This is a patient-randomised prospective clinical trial at three transplant centres in the Northeast, Midwest and South to investigate the effects of a remotely administered adherence programme compared with usual care. The programme monitors potential non-adherence largely levering text message prompts and phenotypes the nature of the non-adhere as cognitive, psychological, medical, social or economic. Additional reminders for medications, clinical appointments and routine self-management support are incorporated to promote adherence to the entire medical regimen. The primary study outcome is medication adherence via 24-hour recall; secondary outcomes include additional medication adherence (ASK-12 self-reported scale, regimen knowledge scales, tacrolimus values), quality of life, functional health status and clinical outcomes (eg, days hospitalised). Study implementation, acceptability, feasibility, costs and potential cost-effectiveness will also be evaluated. The University of Pennsylvania Review Board has approved the study as the single IRB of record (protocol # 849575, V.1.4). Results will be published in peer-reviewed journals and summaries will be provided to study funders. NCT05260268.
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DOI：
10.1002/lt.25830
发表时间：
2020-11
期刊：
Liver transplantation : official publication of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society
影响因子：
--
作者：
Bittermann T;Dwinnells K;Chadha S;Wolf MS;Olthoff KM;Serper M
通讯作者：
Serper M
影响因子：
4.9
作者：
Hardy, Helene;Kumar, Vikram;Skolnik, Paul R.
通讯作者：
Skolnik, Paul R.
影响因子：
3.5
作者：
Herdman, M.;Gudex, C.;Lloyd, A.;Janssen, M. F.;Kind, P.;Parkin, D.;Bonsel, G.;Badia, X.
通讯作者：
Badia, X.
影响因子：
2.1
作者：
Dharancy, Sebastien;Giral, Magali;Pageaux, Georges-Philippe
通讯作者：
Pageaux, Georges-Philippe
DOI：
10.1007/s11901-020-00545-7
发表时间：
2020-12
期刊：
Current hepatology reports
影响因子：
--
作者：
Jones LS;Serper M
通讯作者：
Serper M