Pilot Study of an mHealth Intervention for Living Donor Follow-up

Johns Hopkins University

Status: Active, not recruiting

Conditions: Kidney; Nephrectomy; Living Donors

Treatments: Other: mHealth application

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03400085

K01DK114388 (U.S. NIH Grant/Contract)

IRB00162212

Details and patient eligibility

About

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).

Full 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.

Enrollment: 400 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

Standard of Care

No Intervention group

Description:

The control participants will be instructed to attend required follow-up as is standard of care, and will not receive the mHealth application.

mHealth application

Experimental group

Description:

Participants in the intervention arm will receive the mHealth application at their first post-donation clinic visit. Study personnel will assist participants assigned to the mHealth intervention arm with downloading the application and explain its functioning. Participants will then use the application to complete their required 6-month, 1-year, and 2-year follow-up.

Treatment:

Other: mHealth application