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

NCT03400085 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2025-12-16

No results posted yet for this study

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

Interventions

OTHER

mHealth application

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.

Sponsors & Collaborators

  • Texas Transplant Institute

    collaborator OTHER

  • Vanderbilt University Medical Center

    collaborator OTHER

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • Johns Hopkins University

    lead OTHER

Principal Investigators

  • Daniel Warren, PhD · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-01
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03400085 on ClinicalTrials.gov