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临床试验/NCT03427008
NCT03427008撤回不适用

mDOT: A Pilot Study of Video Directly Observed Therapy for Immunosuppressant Adherence in Adult Kidney Transplant Recipients

Johns Hopkins University1 个研究点 分布在 1 个国家开始时间: 2018年9月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
12-week immunosuppression medication adherence

研究概览

简要总结

The investigators are interested in whether or not the use of a mobile health (mHealth) application increases the rate of immunosuppression medication adherence among adult kidney transplant recipients. The investigators aim to test this by randomly assigning transplant recipients to the intervention (use of an mHealth app to manage and track their immunosuppression regimen) or control arm (standard of care) upon discharge from their initial transplant hospitalization, and tracking medication adherence over time. The study population will be approximately 50 adult kidney transplant recipients at the Johns Hopkins Hospital.

详细描述

In adult kidney transplant recipients, the leading predictor of rejection, kidney loss, and death is immunosuppressive medication nonadherence. An estimated one-third of kidney transplant recipients reportedly experience medication nonadherence, and even minor deviations from the required protocol have been shown to have negative effects. However, due to the lack of systematic measurements of adherence, the direct relationship between the level of immunosuppressive medication adherence and poor outcomes is not well understood. Therefore, the investigators believe that mHealth technologies could be a feasible way to allow clinicians and researchers to better understand baseline adherence measurements, and increase immunosuppression adherence among kidney transplant recipients.

We will use a mobile health platform that enables users to track dose-by-dose medication adherence through asynchronous, video directly observed therapy (DOT). This helps patients take their medication as prescribed and gives providers the assurance that their patients are supported and successful in treatment. DOT is the practice of watching a patient take every dose of medicine in-person, and has typically only been done in extreme cases because it can be both costly and burdensome: DOT is the standard of care for Tuberculosis treatment and has proven high-adherence rates. Through mHealth technology, DOT can be used more broadly and without added burden; emocha's technology allows this through enabling patients to use their mobile application to view their regimen, record themselves taking every dose of their medication, report side effects or symptoms, visualize their treatment progress, access educational content, and track appointments. This information is encrypted and transmitted to a HIPAA-secure web portal for providers to review. The aim of this study is to conduct a randomized control trial to compare medication adherence between patients who use the mHealth system against controls who do not.

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
None

入排标准

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

入选标准

  • •Adults (≥22 years)
  • •Receive a kidney transplant at the Johns Hopkins Hospital

排除标准

  • •Non-English speaking participants

研究组 & 干预措施

Standard of Care

No Intervention

Participants in the control arm will be instructed to take their immunosuppressive medications as prescribed and attend required follow-up as is standard of care, and will not receive the mHealth app.

mHealth Intervention

Experimental

Participants in the intervention arm will receive the mHealth app either while they are an inpatient post-transplant, or at their first post-transplant clinic visit. Study personnel will assist participants assigned to the mHealth intervention arm with downloading the mHealth app and explain its functioning. Participants will then use the application to aid in immunosuppressive medication adherence post-transplant.

干预措施: mHealth Intervention (Other)

结局指标

主要结局

12-week immunosuppression medication adherence

时间窗: 12 weeks

After 12 weeks in the study, patients will complete the 4-item immunosuppressant therapy adherence instrument (ITAS) to determine self-reported medication adherence (scores range from 0-12 with 0 indicating very poor adherence and 12 indicating perfect adherence). Additionally, immunosuppression level trends will be tracked via electronic medical record review to determine medication adherence.

次要结局

  • Feasibility of using the mHealth Application as Assessed by a Semi-Structured Interview and a 17-Item Survey(12 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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