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

Trial Summary

What is the purpose of this trial?

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).

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 data supports the effectiveness of the mHealth application treatment for living donor follow-up?

The mHealth application, like mKidney, is designed to help with follow-up for living kidney donors by making it easier to collect and report necessary health data. While specific effectiveness data for this application is not provided, similar mHealth tools have shown potential benefits in managing health after organ transplants, suggesting they could improve follow-up compliance and patient empowerment. ^{1 2 3 4 5}

Is the mHealth application for living donor follow-up safe for humans?

The research does not provide specific safety data for the mHealth application itself, but it suggests that electronic communication methods like text messaging and email are well-received by living kidney donors and may improve follow-up compliance without indicating any safety concerns. ^{2 3 4 6 7}

How is the mHealth application treatment for living donor follow-up different from other treatments?

The mHealth application for living donor follow-up is unique because it uses mobile technology to provide real-time decision support and communication, allowing patients to manage their own care without waiting for clinician input. This approach is different from traditional follow-up methods, which typically rely on scheduled in-person visits and do not offer the same level of immediate, personalized feedback. ^{8 9 10 11 12}

Research Team

Daniel Warren, PhD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

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 am 18 years old or older.

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of mobile health-based self-management application for posttransplant cares: A systematic review. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Living donors' perception of their quality of health after donation. [2022]

3. Denmark pubmed.ncbi.nlm.nih.gov

Perspectives on implementing mobile health technology for living kidney donor follow-up: In-depth interviews with transplant providers. [2023]

4. Canada pubmed.ncbi.nlm.nih.gov

The Impact of the mKidney mHealth System on Live Donor Follow-Up Compliance: Protocol for a Randomized Controlled Trial. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Mobile Health in Solid Organ Transplant: The Time Is Now. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

The Living Donor Collective: A Scientific Registry for Living Donors. [2023]

7. Denmark pubmed.ncbi.nlm.nih.gov

Electronic messaging and communication with living kidney donors. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Identification of Important Features in Mobile Health Applications for Surgical Site Infection Surveillance. [2020]

9. Korea (South) pubmed.ncbi.nlm.nih.gov

Follow-Up Decision Support Tool for Public Healthcare: A Design Research Perspective. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

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

11. Germany pubmed.ncbi.nlm.nih.gov

A Standards-Based Architecture Proposal for Integrating Patient mHealth Apps to Electronic Health Record Systems. [2018]

12. United States pubmed.ncbi.nlm.nih.gov

Mobile health apps and recovery after surgery: What are patients willing to do? [2017]