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临床试验/NCT03400085
NCT03400085进行中(未招募)不适用

Pilot Study of a Mobile Health Intervention for Living Donor Follow-up

Johns Hopkins University4 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2018年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
400
试验地点
4
主要终点
6-month compliance to follow-up

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 follow-up compliance among living kidney donors. The investigators aim to test this by randomly assigning living kidney donors to the intervention (use of mHealth application to complete required living kidney donor follow-up at 6 months, 1 year, and 2 years) or control arm (standard of care) upon discharge from their initial donation hospitalization, and tracking follow-up compliance over time. The study population will be approximately 400 living kidney donors who undergo donor nephrectomy at Methodist Specialty and Transplant Hospital (200/year for 2 years).

The investigators will also recruit patients from the Vanderbilt University Medical Center into the study, however, these study participants are not a part of the Pilot Randomized Clinical Trial (RCT).

详细描述

Living kidney donation has been promoted as the 'best treatment option' for eligible patients with end-stage renal disease on the transplant waitlist by the American Society of Transplantation. In 2017, 5,264 living kidney donor (LKD) transplants were performed in the United States, representing over one-third of all kidney transplants performed nationally. While living donor nephrectomy is viewed as an overall safe procedure, the surgery does carry associated potential risks, including out-of-pocket costs, difficulty obtaining insurance, and long-term health complications. In 2013, the United Network for Organ Sharing (UNOS) passed new regulations requiring transplant hospitals to collect living kidney donor (LKD) follow-up data for a minimum of 2 years post-donation. Despite this national mandate, less than 50% of transplant hospitals were able to meet reporting thresholds for LKDs who donated in 2013. Documented challenges to collecting this data include cost, donor inconvenience, and data collection burden.

Therefore, novel methods are required to address incomplete donor follow-up. The investigators believe that mobile health (mHealth) systems, such as smartphone applications, would provide an effective, low-cost method of improving living donor follow-up rates. The investigators have built an mHealth system designed for reporting and collecting LKD follow-up data. The mHealth application was created based on previous studies conducted by the study team on the attitudes and perceptions of LKDs at a single transplant center on the use of mHealth for LKD follow-up, as well as after eliciting input from transplant thought leaders in the United States through semi-structured interviews. The aim of this study is to pilot test the mHealth system and compare the investigators' ability to achieve required follow-up at 6 months, 1 year, and 2 years against controls to help estimate potential effect sizes of the intervention.

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

入选标准

  • Adults (≥18 years)
  • Have undergone live donor nephrectomy at Methodist Specialty and Transplant Hospital in San Antonio, Texas
  • Have undergone live donor nephrectomy at Vanderbilt University Medical Center in Nashville, Tennessee

排除标准

  • Participants will only be excluded if they do not consent to the study

结局指标

主要结局

6-month compliance to follow-up

时间窗: 6 months

Compliance with submitting questionnaires and laboratory values within 60 days of the six-month donation anniversary. Participants in the intervention arm will receive notifications when their follow-up is available to complete via the mHealth app, and subsequent notifications thereafter until either the donor completes both clinical and laboratory components of the required follow-up, or they are no longer compliant and within the 60-day window. Participants in the control arm will complete their follow-up as is current standard of care at Texas Transplant Institute.

1-year compliance to follow-up

时间窗: 1 year

Compliance with submitting questionnaires and laboratory values within 60 days of the 1-year donation anniversary. Participants in the intervention arm will receive notifications when their follow-up is available to complete via the mHealth app, and subsequent notifications thereafter until either the donor completes both clinical and laboratory components of the required follow-up, or they are no longer compliant and within the 60-day window. Participants in the control arm will complete their follow-up as is current standard of care at Texas Transplant Institute.

2-year compliance to follow-up

时间窗: 2 years

Compliance with submitting questionnaires and laboratory values within 60 days of the 2-year donation anniversary. Participants in the intervention arm will receive notifications when their follow-up is available to complete via the mHealth app, and subsequent notifications thereafter until either the donor completes both clinical and laboratory components of the required follow-up, or they are no longer compliant and within the 60-day window. Participants in the control arm will complete their follow-up as is current standard of care at Texas Transplant Institute.

次要结局

  • 2-year center follow-up compliance(2 years)
  • 6-month center follow-up compliance(6 months)
  • 1-year center follow-up compliance(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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