A Randomized Trial of a Multicomponent Intervention to Promote Medication Adherence: The Teen Adherence in Kidney Transplant Effectiveness of Intervention Trial (TAKE-IT).
A Randomized Trial of a Multicomponent Intervention to Promote Medication Adherence: The Teen Adherence in Kidney Transplant Effectiveness of Intervention Trial (TAKE-IT).
复制标题
DOI：
10.1053/j.ajkd.2017.12.012
复制
发表时间：
2018-07
期刊：
影响因子：
--
通讯作者：
Furth SL
中科院分区：
文献类型：
--
作者：
Foster BJ;Pai ALH;Zelikovsky N;Amaral S;Bell L;Dharnidharka VR;Hebert D;Holly C;Knauper B;Matsell D;Phan V;Rogers R;Smith JM;Zhao H;Furth SL
对免疫抑制药物的依从性差是儿童和年轻人过早移植物丢失的主要原因。多组成部分的干预措施已显示出希望，但尚未得到充分评价。一项旨在评估基于临床的依从性促进干预措施疗效的非盲、平行组随机试验。纳入了加拿大和美国8家肾移植中心（2012年2月至2016年5月）的11-24岁且移植后≥3个月的肾移植受者。在3个月的导入期内，对所有参与者的依从性进行电子监测，随后进行12个月的干预。分配至TAKE-IT干预的参与者可以选择接收短信、电子邮件和/或视觉提示剂量提醒，并在与参与者一起审查前3个月的依从性数据时，每隔3个月与教练会面。“以问题为中心的问题解决”被用来解决参与者选择为重要的依从性障碍。被分配到对照组的参与者每隔3个月与教练会面，但没有收到关于依从性数据的反馈。主要结局是在每个观察日电子测量的“服用”依从性（服用规定剂量的免疫抑制药物的比例）和“定时”依从性（在规定给药时间前1小时和给药时间后2小时之间服用免疫抑制药物的比例）。次要结局包括他克莫司谷浓度的标准差、自我报告的依从性、急性排斥反应和移植失败。有81名患者被分配到干预组（中位年龄15.5岁; 57%为男性），88名患者被分配到对照组（中位年龄15.8岁; 61%为男性）。64名干预组和74名对照组参与者的电子依从性数据。与对照组相比，干预组的参与者服用处方药物（OR，1.66; 95%CI，1.15-2.39]）和在规定时间或接近规定时间服用药物（OR，1.74; 95%CI，1.21-2.50）的几率显著更大。一些参与者缺乏电子依从性数据可能会引入偏倚。临床结局的统计学把握度较低。多组分服用IT干预导致比对照条件下更好的药物依从性。更好的药物依从性可能会导致移植物结局的改善，但这需要在更大规模的研究中证明。
Poor adherence to immunosuppressive medications is a major cause of premature graft loss among children and young adults. Multicomponent interventions have shown promise, but have not been fully evaluated. Unblinded, parallel arm randomized trial to assess the efficacy of a clinic-based adherence-promoting intervention. Prevalent kidney transplant recipients 11–24 years of age and ≥3 months post-transplantation at 8 kidney transplant centers in Canada and the United States (Feb. 2012 – May 2016) were included. Adherence was electronically monitored in all participants during a 3-month run-in, followed by a 12-month intervention. Participants assigned to the TAKE-IT intervention could choose to receive text message, email, and/or visual cue dose reminders, and met with a coach at 3-month intervals when adherence data from the prior 3 months were reviewed with the participant. ‘Action-Focused Problem-Solving’ was used to address adherence barriers selected as important by the participant. Participants assigned to the control group met with coaches at 3-month intervals but received no feedback about adherence data. The primary outcomes were electronically-measured ‘taking’ adherence (the proportion of prescribed doses of immunosuppressive medications taken) and ‘timing’ adherence (the proportion of doses of immunosuppressive medications taken between 1 hour before and 2 hours after the prescribed time of administration) on each day of observation. Secondary outcomes included standard deviation of tacrolimus trough levels, self-reported adherence, acute rejection, and graft failure. There were 81 patients assigned to intervention (median age 15.5 years; 57% male) and 88 to the control group (median age 15.8 years; 61% male). Electronic adherence data were available for 64 intervention and 74 control participants. Participants in the intervention group had significantly greater odds of taking prescribed medications (OR, 1.66; 95% CI, 1.15–2.39]) and taking medications at or near the prescribed time (OR, 1.74; 95% CI, 1.21–2.50) than controls. Lack of electronic adherence data for some participants may have introduced bias. There was low statistical power for clinical outcomes. The multicomponent TAKE-IT intervention resulted in significantly better medication adherence than the control condition. Better medication adherence may result in improved graft outcomes, but this will need to be demonstrated in larger studies.
登录
查看更多内容
影响因子：
3.1
作者：
Langkamp, Diane L.;Lehman, Amy;Lemeshow, Stanley
通讯作者：
Lemeshow, Stanley
影响因子：
8
作者：
Modi, Avani C.;Pai, Ahna L.;Drotar, Dennis
通讯作者：
Drotar, Dennis
影响因子：
1.3
作者：
Dobbels, F.;Ruppar, T.;Fine, R. N.
通讯作者：
Fine, R. N.
影响因子：
8.8
作者：
Fine, R. N.;Becker, Y.;Dobbels, F.
通讯作者：
Dobbels, F.
影响因子：
8.8
作者：
Kim, J. J.;Balasubramanian, R.;Marks, S. D.
通讯作者：
Marks, S. D.