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临床试验/NCT03540121
NCT03540121已完成不适用

Improving Adherence in Kidney Recipients: a Randomized Controlled Trial of a Post-transplant Education Intervention

University of Saskatchewan3 个研究点 分布在 2 个国家目标入组 173 人开始时间: 2018年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
173
试验地点
3
主要终点
Difference in adherence to immunosuppressant medications between intervention and control (self-report)

研究概览

简要总结

This study aims to test the effectiveness of an electronic-based video intervention and behavioral contract on improving medication adherence among kidney transplant recipients.

详细描述

Non-adherence to immunosuppressive medications is a major problem after kidney transplantation, leading to increased rejections, hospitalizations and health care expenditures. Effective educational opportunities may positively influence adherence, especially when combined with a behavior intervention. However, increasing education and support to transplant recipients demands greater use of care providers' time and resources in a health care system that is already stretched.

A patient-oriented video series has been developed according to best practices for transplant education, featuring an animated character embarking on a transplant journey. Animated segments illustrate difficult concepts for patients with poor health literacy, and patient narratives provide support and encouragement. A multicenter randomized controlled trial will be conducted with 4 sites across North America. Patients will be randomized (1:1) to either the intervention (i.e., home-based video education + adherence contract plus usual care) or usual care alone. Patients will be enrolled in the study prior to hospital discharge and will be provided with access to the video intervention and contract electronically. The primary outcome will be adherence at 12 months post-transplant, as measured by self-report (BAASIS), and variability in immunosuppressant levels. Secondary outcomes include the change in knowledge score between the intervention and control in groups (measured by the Kidney Transplant Understanding Tool); differences in self-efficacy (Generalized Self-efficacy Scale), beliefs about medicines (Beliefs of Medicine Questionnaire), and quality of life (SF-12). Individualized viewing statistics will be analyzed to determine patient uptake, and satisfaction about the educational experience will be captured on a self-reported survey.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • •18 or older
  • •can speak and understand and read English
  • •receive their first kidney transplant at one of the participating sites during enrolment

排除标准

  • •do not meet inclusion criteria
  • •have previously participated in a study entitle "Improving health outcomes of kidney recipients: A randomized controlled trial of a pre-transplant education intervention"

研究组 & 干预措施

Standard education

No Intervention

standard of care education provided at each transplant center (control emails will be provided at intervention time points)

Video education + adherence contract

Experimental

electronically delivered video education (at transplant discharge) + electronic adherence contract (1 month after enrolment)

干预措施: Video education + adherence contract (Behavioral)

结局指标

主要结局

Difference in adherence to immunosuppressant medications between intervention and control (self-report)

时间窗: 3 months and 12 months after enrolment

The Basel Assessment of Adherence to Immunosuppressive medications (BAASIS) will be sent electronically by self-reported survey. An answer of 'yes' to any of the questions (pertaining to missing doses, drug holidays, timing, and dose reduction) will constitute non-adherence as a binary outcome. • A continuous measure of adherence will also be determined in each individual using a visual analogue scale.

Difference in adherence to immunosuppressant medications between intervention and control (immunosuppressant blood levels)

时间窗: 3 months and 12 months after enrolment

Immunosuppressant levels (tacrolimus, cyclosporine or sirolimus) will be collected as per routine practice, and will be standardized to the patient specific target. Intra-patient coefficients of variation (CV) will be used as a measure of trough level variability, and percentage of sub-therapeutic levels will be determined for each patient.

次要结局

  • Difference in education satisfaction between intervention and control(3 months and 12 months after enrolment)
  • Cost of administering the intervention(study end (12 months after enrolment))
  • Video viewing habits (duration of viewing time)(study end (12 months after enrolment))
  • Days in hospital(study end (12 months after enrolment))
  • Difference in self efficacy between intervention and control(3 months and 12 months after enrolment)
  • Difference in changes in kidney transplant knowledge between intervention and control(3 months and 12 months after enrolment)
  • Difference in quality of life between intervention and control(3 months and 12 months after enrolment)
  • Difference in beliefs about medication between intervention and control(3 months and 12 months after enrolment)
  • Difference in adherence to transplant appointments between intervention and control(study end (12 months after enrolment))

研究者

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

Holly Mansell

Associate Professor, College of Pharmacy and Nutrition

University of Saskatchewan

研究点 (3)

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