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临床试验/NCT03104868
NCT03104868已完成不适用

Transplant Regimen Adherence for Kidney Recipients by Engaging Information Technologies: The TAKE IT Trial

Northwestern University4 个研究点 分布在 1 个国家目标入组 449 人开始时间: 2018年5月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
449
试验地点
4
主要终点
Rx Pill Count

研究概览

简要总结

The investigators will evaluate a technology-enabled strategy designed to promote medication adherence, routinely monitor regimen use, and mobilize appropriate transplant center resources to respond early to kidney transplant recipients demonstrating inadequate adherence.

详细描述

The investigators will evaluate a technology-enabled strategy designed to promote medication adherence, routinely monitor regimen use, and mobilize appropriate transplant center resources to respond early to kidney transplant recipients demonstrating inadequate adherence.

Among patients receiving a kidney transplant (KT), the 5-year risk of organ (graft) failure is high; 30% for deceased donor and 27% for living donor recipients. Medication non-adherence is a leading root cause of graft failure, and KT recipients have the highest reported rate of poor adherence (~35%) among all organ transplant recipients. Despite many attempts, there have been few successful interventions evaluated to date that have significantly improved KT recipients' regimen adherence and subsequent health outcomes over time.

There are many reasons why individuals may not take medication regimens as prescribed, including but not limited to: forgetfulness, misunderstanding, regimen complexity, side effects, health issues, social support, motivation and cost. Therefore no single solution can address all patients. A healthcare team must understand the precise nature of a patient's adherence barriers in order to properly respond. Yet medication adherence is not clinically assessed as part of routine post-transplant care, and prior studies have found that medical staff cannot readily identify poor adherence among patients, let alone the reasons why. Using evidence from the research team's extensive previous studies in other chronic disease contexts, the investigators will implement and comprehensively test a potentially low cost, 'low touch', thus highly scalable intervention: the Transplant regimen Adherence for Kidney recipients by Engaging Information Technologies (TAKE IT) strategy.

The TAKE IT strategy leverages a transplant center's electronic health record and a web-based patient portal, as well as mobile technology to: 1) educate patients on their prescribed Rx regimens, 2) help them organize their daily regimen schedule in the most efficient manner, 3) remind them via SMS (Short Message Service) text when to take their medicine, 4) routinely monitor regimen use, and 5) provide care alerts to engage appropriate transplant center clinical staff (e.g. nurse coordinator, pharmacist, social worker) when medication concerns are detected. All components of the TAKE IT strategy have been developed with prior NIH support, refined with 'user' input (patient, family, clinic staff), and their efficacy tested in non-transplant settings.

The research team's primary aim and hypotheses (H) are to:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Investigator)

盲法说明

We will blind: 1) research interviewers involved with outcomes assessment, 2) personnel involved in statistical analyses (Dr. Kwasny, Ms. Patel), 3) principal investigators (Wolf, Ladner). Site project managers will have access to study arm assignments to initiate TAKE IT components to those randomized to receive them.

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age 21 or older
  • 5 weeks to 24 months post kidney transplant
  • English speaking
  • primarily responsible for administering own medication
  • owns a cell phone and comfortable receiving text messages
  • has access to and proficiency using internet in home

排除标准

  • any severe, uncorrectable vision, hearing or cognitive impairments

结局指标

主要结局

Rx Pill Count

时间窗: 1 year - 1.5 years

An in-person pill count using established guidelines will be conducted. When in-person interviews are not possible, pill count will be done over the phone. Adherence will be assessed within drugs. The proportion of pills taken/pills prescribed will be calculated per medication. Patients will be considered non-adherent for a medication if this score is \<=80% and adherent if pills taken/pill prescribed\>80% (0=non-adherent, 1=adherent).

次要结局

  • Correct Medication Dosing Over Past 24 Hours (24 Hour Recall)(1 year)
  • Ask-12(1 year)
  • Change in Estimated Glomerular Filtration Rate (eGFR), ml/Min/1.73m^2(Value at 2 years minus value at baseline)
  • Re-hospitalization(2 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael S. Wolf

Associate Division Chief - Division of General Internal Medicine

Northwestern University

研究点 (4)

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