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

NCT03400085 | Active Not Recruiting

• 2 other identifiers: IRB00162212K01DK114388
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 2

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).

Conditions

Living Donors; Nephrectomy; Kidney

Keywords

mHealth; living donor kidney transplant; follow-up; health utilization

Outcome Measures

Primary Outcomes (3)

• 6-month compliance to follow-up

  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.

  6 months

• 1-year compliance to follow-up

  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.

  1 year

• 2-year compliance to follow-up

  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.

  2 years

Secondary Outcomes (3)

• 6-month center follow-up compliance

  6 months

• 1-year center follow-up compliance

  1 year

• 2-year center follow-up compliance

  2 years

Study Arms (2)

Standard of Care

NO INTERVENTION

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

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.

Other: mHealth application

Interventions

mHealth application OTHER

The intervention is an mHealth smartphone application designed for living kidney donors to complete their required 2-year follow-up. It allows the donor to input the answers to the clinical survey responses, as well as upload a picture of their lab values.

Also known as: Application

mHealth application

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Texas Transplant Institute: collaborator
• Vanderbilt University Medical Center: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Johns Hopkins University: lead

Study Sites (2)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Methodist Specialty and Transplant Hospital

San Antonio, Texas, 78229, United States

Location

Related Publications (12)

• LaPointe Rudow D, Hays R, Baliga P, Cohen DJ, Cooper M, Danovitch GM, Dew MA, Gordon EJ, Mandelbrot DA, McGuire S, Milton J, Moore DR, Morgievich M, Schold JD, Segev DL, Serur D, Steiner RW, Tan JC, Waterman AD, Zavala EY, Rodrigue JR. Consensus conference on best practices in live kidney donation: recommendations to optimize education, access, and care. Am J Transplant. 2015 Apr;15(4):914-22. doi: 10.1111/ajt.13173. Epub 2015 Feb 3.

  PMID: 25648884 BACKGROUND

• Organ Procurement and Transplantation Network. National Data 2017.

  BACKGROUND

• Boyarsky BJ, Massie AB, Alejo JL, Van Arendonk KJ, Wildonger S, Garonzik-Wang JM, Montgomery RA, Deshpande NA, Muzaale AD, Segev DL. Experiences obtaining insurance after live kidney donation. Am J Transplant. 2014 Sep;14(9):2168-72. doi: 10.1111/ajt.12819. Epub 2014 Jul 16.

  PMID: 25041695 BACKGROUND

• Rodrigue JR, Schold JD, Morrissey P, Whiting J, Vella J, Kayler LK, Katz D, Jones J, Kaplan B, Fleishman A, Pavlakis M, Mandelbrot DA; KDOC Study Group. Predonation Direct and Indirect Costs Incurred by Adults Who Donated a Kidney: Findings From the KDOC Study. Am J Transplant. 2015 Sep;15(9):2387-93. doi: 10.1111/ajt.13286. Epub 2015 May 5.

  PMID: 25943721 BACKGROUND

• Segev DL, Muzaale AD, Caffo BS, Mehta SH, Singer AL, Taranto SE, McBride MA, Montgomery RA. Perioperative mortality and long-term survival following live kidney donation. JAMA. 2010 Mar 10;303(10):959-66. doi: 10.1001/jama.2010.237.

  PMID: 20215610 BACKGROUND

• OPTN Policy 18 Living Donor Data Submission Requirements. 2016: 220.

  BACKGROUND

• Henderson ML, Thomas AG, Shaffer A, Massie AB, Luo X, Holscher CM, Purnell TS, Lentine KL, Segev DL. The National Landscape of Living Kidney Donor Follow-Up in the United States. Am J Transplant. 2017 Dec;17(12):3131-3140. doi: 10.1111/ajt.14356. Epub 2017 Jun 30.

  PMID: 28510355 BACKGROUND

• Ommen ES, LaPointe Rudow D, Medapalli RK, Schroppel B, Murphy B. When good intentions are not enough: obtaining follow-up data in living kidney donors. Am J Transplant. 2011 Dec;11(12):2575-81. doi: 10.1111/j.1600-6143.2011.03815.x. Epub 2011 Nov 4.

  PMID: 22054024 BACKGROUND

• Mandelbrot DA, Pavlakis M. Living donor practices in the United States. Adv Chronic Kidney Dis. 2012 Jul;19(4):212-9. doi: 10.1053/j.ackd.2012.04.010.

  PMID: 22732040 BACKGROUND

• Waterman AD, Dew MA, Davis CL, McCabe M, Wainright JL, Forland CL, Bolton L, Cooper M. Living-donor follow-up attitudes and practices in U.S. kidney and liver donor programs. Transplantation. 2013 Mar 27;95(6):883-8. doi: 10.1097/TP.0b013e31828279fd.

  PMID: 23388736 BACKGROUND

• Mandelbrot DA, Pavlakis M, Karp SJ, Johnson SR, Hanto DW, Rodrigue JR. Practices and barriers in long-term living kidney donor follow-up: a survey of U.S. transplant centers. Transplantation. 2009 Oct 15;88(7):855-60. doi: 10.1097/TP.0b013e3181b6dfb9.

  PMID: 19935453 BACKGROUND

• Fleming JN, Taber DJ, McElligott J, McGillicuddy JW, Treiber F. Mobile Health in Solid Organ Transplant: The Time Is Now. Am J Transplant. 2017 Sep;17(9):2263-2276. doi: 10.1111/ajt.14225. Epub 2017 Mar 17.

  PMID: 28188681 BACKGROUND

Study Officials

• Daniel Warren, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 9, 2018
• First Posted: January 17, 2018
• Study Start: May 1, 2018
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)