Nephrectomy Clinical Trial
— mHealthOfficial title:
Pilot Study of a Mobile Health Intervention for Living Donor Follow-up
Verified date | January 2024 |
Source | Johns Hopkins University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Active, not recruiting |
Enrollment | 400 |
Est. completion date | January 2025 |
Est. primary completion date | January 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Vanderbilt University Medical Center | Nashville | Tennessee |
United States | Methodist Specialty and Transplant Hospital | San Antonio | Texas |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Texas Transplant Institute, Vanderbilt University Medical Center |
United States,
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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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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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. — View Citation
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* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | 6-month center follow-up compliance | Overall center rate of compliance with follow-up with 80% of all donors within 60 days of the six-month donation anniversary. | 6 months | |
Secondary | 1-year center follow-up compliance | Overall center rate of compliance with follow-up with 80% of all donors within 60 days of the 1-year donation anniversary. | 1 year | |
Secondary | 2-year center follow-up compliance | Overall center rate of compliance with follow-up with 80% of all donors within 60 days of the 2-year donation anniversary. | 2 years |
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