Pilot Study of an mHealth Intervention for Living Donor Follow-up
| Status: | Recruiting |
|---|---|
| Conditions: | Nephrology |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/11/2018 |
| Start Date: | May 1, 2018 |
| End Date: | May 2022 |
| Contact: | Macey Henderson, JD, PhD |
| Email: | macey@jhmi.edu |
| Phone: | 443-287-6649 |
Pilot Study of a Mobile Health Intervention for Living Donor Follow-up
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).
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).
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.
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.
Inclusion Criteria:
- Adults (≥18 years)
- Have undergone live donor nephrectomy at Methodist Specialty and Transplant Hospital
in San Antonio, Texas
Exclusion Criteria:
- Participants will only be excluded if they do not consent to the study
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