McGillicuddy John, Chandler Jessica, Sox Luke, Mueller Martina, Nemeth Lynne, Baliga Prabhakar, Treiber Frank
College of Medicine, Medical University of South Carolina, Charleston, SC, United States.
College of Nursing, Medical University of South Carolina, Charleston, SC, United States.
JMIR Res Protoc. 2019 Jun 21;8(6):e13351. doi: 10.2196/13351.
Kidney transplant recipients' poor medication adherence and poor control of comorbidities, particularly hypertension, are risk factors for graft rejection, graft loss, and death. Few randomized controlled trials (RCTs) have been successful in improving sustained medication adherence and blood pressure control among kidney transplantation recipients. We provide rationale for an RCT evaluating a mobile health medical self-management system for kidney transplantation recipients called Smartphone Medication Adherence Saves Kidneys (SMASK).
Our objective is to determine whether SMASK is efficacious in improving medication adherence and sustaining blood pressure control among kidney transplantation recipients with uncontrolled hypertension and poor medication adherence compared to an enhanced standard care.
This two-arm, 6-month, phase II single-site efficacy RCT will involve 80 kidney transplantation recipients. Participants will be randomly assigned to the SMASK intervention arm or control arm. SMASK includes multilevel components: automated reminders from an electronic medication tray; tailored text messages and motivational feedback, guided by the self-determination theory; and automated summary reports for providers. Evaluations will be conducted preintervention, at 3 and 6 months, and posttrial at 12 months. Specific aims are to test the hypotheses that compared to standard care, the SMASK cohort will demonstrate significantly improved changes at 3, 6, and 12 months in the primary outcome variables medication adherence (proportion with electronic monitor-derived score >0.90) and blood pressure control (proportion meeting and sustaining adherence to the Kidney Disease Improving Global Outcomes [KDIGO] guidelines for blood pressure control); the secondary outcome variables provider adherence to KDIGO guidelines, measured by timing of medication changes and changes in self-determination theory constructs; and the exploratory outcome variables estimated glomerular filtration rate, variability in calcineurin inhibitor trough levels, and proportion of patients meeting and sustaining the 24-hour ambulatory blood pressure below 130/80 mm Hg. After the 6-month evaluation, interviews with a random sample of SMASK subjects (n=20) and health care providers (n=3-5) will assess user reactions including acceptability, usability, and aids/barriers to sustainability. Data from the RCT and interviews will be triangulated to further refine and optimize SMASK and prepare for a multisite effectiveness RCT.
The SMASK project received funding from National Institute of Diabetes and Digestive and Kidney Diseases in June 2016, obtained institutional review board approval in April 2016, and began data collection in July 2016. As of July 2018, we completed enrollment with a total of 80 participants.
This study will provide data regarding the efficacy of SMASK to improve medication adherence and blood pressure control in a cohort of hypertensive kidney transplant recipients. An efficacious SMASK intervention will pave the way for a larger, multicenter, effectiveness RCT powered sufficiently to evaluate clinical events in a real-world setting and with the potential to demonstrate improved outcomes at lower cost than standard care.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/13351.
肾移植受者药物依从性差以及合并症（尤其是高血压）控制不佳是移植肾排斥、移植肾丢失和死亡的危险因素。很少有随机对照试验（RCT）能成功提高肾移植受者的持续药物依从性和血压控制水平。我们为一项RCT提供理论依据，该试验评估一种针对肾移植受者的移动健康医疗自我管理系统，即智能手机药物依从性拯救肾脏（SMASK）系统。
我们的目的是确定与强化标准护理相比，SMASK在改善高血压且药物依从性差的肾移植受者的药物依从性和维持血压控制方面是否有效。
这项双臂、为期6个月的II期单中心疗效RCT将纳入80名肾移植受者。参与者将被随机分配到SMASK干预组或对照组。SMASK包括多个层面的组成部分：电子药盒的自动提醒；以自我决定理论为指导的定制短信和激励反馈；以及为医护人员提供的自动总结报告。评估将在干预前、3个月和6个月时进行，并在试验后12个月时进行。具体目标是检验以下假设：与标准护理相比，SMASK队列在3个月、6个月和12个月时，主要结局变量药物依从性（电子监测器得出的分数>0.90的比例）和血压控制（达到并维持对改善全球肾脏病预后（KDIGO）血压控制指南的依从性的比例）将有显著改善；次要结局变量为医护人员对KDIGO指南的依从性，通过药物变更时间和自我决定理论结构的变化来衡量；探索性结局变量为估计肾小球滤过率、钙调神经磷酸酶谷浓度的变异性，以及达到并维持24小时动态血压低于130/80 mmHg的患者比例。在6个月的评估之后，对SMASK受试者（n = 20）和医疗保健提供者（n = 3 - 5）的随机样本进行访谈，将评估用户反应，包括可接受性、可用性以及可持续性的促进因素/障碍。来自RCT和访谈的数据将进行三角验证，以进一步完善和优化SMASK，并为多中心有效性RCT做准备。
SMASK项目于2016年6月获得美国国立糖尿病、消化和肾脏疾病研究所的资助，2016年4月获得机构审查委员会的批准，并于2016年7月开始数据收集。截至2018年7月，我们共招募了80名参与者，完成了入组。
本研究将提供有关SMASK在改善高血压肾移植受者队列的药物依从性和血压控制方面疗效的数据。有效的SMASK干预将为更大规模的多中心有效性RCT铺平道路，该RCT有足够的能力在现实环境中评估临床事件，并有潜力以低于标准护理的成本证明改善的结局。
国际注册报告识别号（IRRID）：DERR1-10.2196/13351
