mHealth Application for Living Donor Follow-Up

(mHealth Trial)

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Non-consent

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a mobile app (mHealth application) can assist living kidney donors in maintaining their medical follow-ups. Participants are divided into two groups: one uses the app to track check-ups, while the other follows the usual care routine. The researchers aim to determine if the app improves follow-up compliance at 6 months, 1 year, and 2 years after donation. The study seeks individuals who have donated a kidney at either Methodist Specialty and Transplant Hospital or Vanderbilt University Medical Center. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance post-donation care for future kidney donors.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this mHealth application is safe for living kidney donors?

Research has shown that using a mobile health (mHealth) app in healthcare is generally safe. Specifically, studies have examined mHealth apps designed to monitor the health of living kidney donors after surgery. These apps assist in tracking and managing donor health.

Past research indicates that users find mHealth apps easy to use, with no major reports of problems caused by these digital tools. They primarily improve communication and ensure consistent follow-up care. This suggests that using an app like the one in this trial is generally safe for participants.

While minor technical issues may occur, patients have reported a positive overall experience. The app helps streamline healthcare processes without adding health risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the mHealth application for living donor follow-up because it offers a modern twist on post-donation care. Unlike traditional follow-up methods that rely on in-person visits and phone calls, this app empowers donors to manage their health checks digitally. This new delivery method allows for more convenient and potentially more consistent monitoring, as users can complete their required follow-ups at the 6-month, 1-year, and 2-year marks directly through the app. By streamlining the follow-up process, the app could lead to improved health outcomes and a better overall experience for living donors.

What evidence suggests that this mHealth application is effective for increasing follow-up compliance among living kidney donors?

This trial will compare a mobile health (mHealth) application with standard care for living kidney donors. Research has shown that mHealth apps can assist donors in maintaining their follow-up appointments, though the benefits vary over time. One study found that these apps improved follow-up rates at 6 months after donation. However, there was no noticeable improvement at 1 year and 2 years post-donation. Despite these mixed results, mHealth tools might still enhance donor engagement, particularly in the short term. As this is a developing field, further research is needed to determine how these apps can be more effective over longer periods. ^{3 6 7 8 9}

Who Is on the Research Team?

Daniel Warren, PhD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for adults who have donated a kidney and undergone nephrectomy at Methodist Specialty and Transplant Hospital in San Antonio, Texas or Vanderbilt University Medical Center in Nashville, Tennessee. Participants must consent to the study.

Inclusion Criteria

I had a kidney removal surgery from a living donor at Methodist Specialty and Transplant Hospital in San Antonio, Texas.

I had a kidney removal surgery from a living donor at Vanderbilt University Medical Center.

Exclusion Criteria

Participants who do not consent to the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Post-Donation

Participants receive the mHealth application and are instructed on its use at their first post-donation clinic visit

1 visit

1 visit (in-person)

Follow-up

Participants complete required follow-up at 6 months, 1 year, and 2 years using the mHealth application or standard of care

2 years

3 visits (virtual or in-person)

What Are the Treatments Tested in This Trial?

Interventions

• mHealth application

Trial Overview The study tests if a mobile health (mHealth) application can improve follow-up compliance among living kidney donors post-donation. Donors are randomly placed into two groups: one uses the mHealth app for follow-ups; the other follows standard care.

How Is the Trial Designed?

Group I: mHealth application Experimental Treatment 1 Intervention

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.

Group II: Standard of Care Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

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

Collaborator

Trials

2,513

Recruited

4,366,000+

Texas Transplant Institute

Collaborator

Trials

1

Recruited

400+

Vanderbilt University Medical Center

Collaborator

Trials

922

Recruited

939,000+

Published Research Related to This Trial

The study presents a new architecture for integrating mobile health applications (mHealth Apps) with electronic health records (EHRs), enabling bi-directional data exchange to improve patient engagement in healthcare management.

Using a case study for congestive heart failure patients, the architecture allows clinicians to prescribe monitoring procedures through EHRs, which are then communicated to mHealth Apps, facilitating real-time patient monitoring and reporting without local data storage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Standards-Based Architecture Proposal for Integrating Patient mHealth Apps to Electronic Health Record Systems. Marceglia, S., Fontelo, P., Rossi, E., et al.[2018]

Mobile health applications (m-Health apps) have been shown to improve medication adherence and self-management in transplant patients, with 62.5% of studies indicating positive outcomes in these areas.

The systematic review highlighted that 37.5% of the studies focused on lung transplantation, emphasizing the importance of m-Health in managing post-transplant care, which is crucial for preventing medication nonadherence and subsequent graft loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of mobile health-based self-management application for posttransplant cares: A systematic review. Abasi, S., Yazdani, A., Kiani, S., et al.[2022]

Out of 10 evaluated mHealth applications for surgical site infection (SSI) detection, only two are currently in full clinical use, highlighting a gap in practical implementation despite the availability of technology.

The apps collected various data types, such as wound photographs and medication adherence, but their integration with electronic health records varied, indicating a need for standardized evaluation methods in mHealth technologies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identification of Important Features in Mobile Health Applications for Surgical Site Infection Surveillance. Chernetsky Tejedor, S., Sharma, J., Lavallee, DC., et al.[2020]

mHealth systems can automatically collect and analyze glucose data, providing real-time decision support for both patients and healthcare professionals, which can lead to timely and personalized treatment decisions.

While mHealth shows promise for diabetes management, rigorous testing and regulatory approval are necessary to ensure safety, effectiveness, and to address privacy, clinical, and economic concerns for widespread adoption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The current status of mHealth for diabetes: will it be the next big thing? Klonoff, DC.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40145946/

Effectiveness of a Mobile Health System on Compliance With ... Conclusion: mHealth technologies improved 6-month follow-up, but did not impact 1- and 2-year LKD follow-up in this single-center RCT. Other strategies, such as ...

2. researchprotocols.org researchprotocols.org/2019/1/e11000/

The Impact of the mKidney mHealth System on Live Donor ... Current Landscape of Living Kidney Donor Follow-Up. OPTN/UNOS has collected postdonation follow-up data on LKDs since 1999. However, LKD ...

3. researchgate.net researchgate.net/publication/390313304_Effectiveness_of_a_Mobile_Health_System_on_Compliance_With_2-Year_Living_Kidney_Donor_Follow-Up_in_the_United_States

Effectiveness of a Mobile Health System on Compliance ... Conclusion mHealth technologies improved 6‐month follow‐up, but did not impact 1‐ and 2‐year LKD follow‐up in this single‐center RCT. Other ...

4. trial.medpath.com trial.medpath.com/clinical-trial/e12d8cb21ba34b4a/pilot-study-mobile-health-intervention

Pilot Study of an mHealth Intervention for Living Donor Follow ... Overall center rate of compliance with follow-up with 80% of all donors within 60 days of the 2-year donation anniversary. 6-month center follow-up compliance ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6690770/

In-Depth Interviews with Transplant Providers - PMC United States transplant centers are required to report follow-up data for living kidney donors for 2 years post-donation. However, living kidney donor ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6350092/

The Impact of the mKidney mHealth System on Live Donor ... Current Landscape of Living Kidney Donor Follow-Up. OPTN/UNOS has collected postdonation follow-up data on LKDs since 1999. However, LKD follow- ...

7. researchprotocols.org researchprotocols.org/2025/1/e67588/

Using Linked Health Service Data in Multimodal Modeling ... The Impact of the mKidney mHealth System on Live Donor Follow-Up Compliance: Protocol for a Randomized Controlled Trial. Macey L Henderson ...

8. mhealth.jmir.org mhealth.jmir.org/2018/10/e11192/

Assessing the Attitudes and Perceptions Regarding the Use of ... Novel smartphone-based mobile health (mHealth) technologies might reduce the burden of living kidney donor follow-up for centers and donors.

9. journals.lww.com journals.lww.com/transplantationdirect/fulltext/2021/05000/outcomes_of_living_kidney_donor_candidate.1.aspx

Outcomes of Living Kidney Donor Candidate Evaluations in... These results suggest that a comprehensive living donor registry is both feasible and necessary to assess long-term outcomes that may inform decision making.