Clinical trial NCT03400085: Pilot Study of an mHealth Intervention for Living Donor Follow-up
Official title: Pilot Study of a Mobile Health Intervention for Living Donor Follow-up
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Living Donors
Nephrectomy
Kidney
Keywords: mHealth
living donor kidney transplant
follow-up
health utilization
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Texas Transplant Institute
name: Vanderbilt University Medical Center
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2018-01-17
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a single-center, prospective, randomized control trial with two arms. Participants in the intervention arm will use an mHealth application to complete their mandated living kidney donor follow-up at 6 months, 1 year, and 2 years, and participants in the control arm will receive the current standard of follow-up care and complete their required follow-up without the use of an mHealth application.

Living Kidney Donors at the Vanderbilt University Medical Center are also being given the option to use the mKidney system, however, these study participants are not a part of the Pilot RCT.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: 6-month compliance to follow-up
timeFrame: 6 months
measure: 1-year compliance to follow-up
timeFrame: 1 year
measure: 2-year compliance to follow-up
timeFrame: 2 years
Secondary outcomes:
measure: 6-month center follow-up compliance
timeFrame: 6 months
measure: 1-year center follow-up compliance
timeFrame: 1 year
measure: 2-year center follow-up compliance
timeFrame: 2 years
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: San Antonio
country: United States
facility: Methodist Specialty and Transplant Hospital
state: Texas
Study officials:
affiliation: Johns Hopkins University
name: Daniel Warren, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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