The Donor App for Kidney Failure

Recruiting at 5 trial locations

Overseen By Andrew Cameron, MD PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Under 18, Multiple organ lists

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

1000 Participants Needed

Trial Summary

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 treatment The Donor App for kidney failure?

Research on similar mobile health applications for kidney transplant recipients shows that these tools can improve medication adherence and manage conditions like high blood pressure, which are crucial for better kidney health. These apps provide real-time feedback and help patients manage their health more effectively. ^{1 2 3 4 5}

Is The Donor App safe for use in humans?

There is no specific safety data available for The Donor App or its other names. However, general safety concerns in kidney-related digital applications include risks of adverse drug reactions and other safety events in patients with kidney conditions. ^{3 5 6 7 8}

How is The Donor App treatment different from other treatments for kidney failure?

The Donor App is unique because it uses technology to connect potential kidney donors with transplant candidates, increasing awareness and linkage between them, which is not a focus of traditional treatments for kidney failure. ^{3 4 5 9 10}

What is the purpose of this trial?

This study utilizes a web-based application to help patients on the organ transplant waitlist communicate patient's need for a living donor via social media and provide interested potential donors the opportunity to engage with the evaluation process.

Research Team

Andrew Cameron, MD PhD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

This trial is for adults over 18 who are on the waiting list for a kidney or liver transplant at a participating center. It's not open to those under 18, not on the transplant waitlist, or waiting for multiple organ transplants.

Inclusion Criteria

I am on the waiting list for a kidney or liver transplant at a participating center.

Exclusion Criteria

I am under 18 years old.

I am not waiting for a kidney or liver transplant.

You are on waiting lists for transplants for more than one organ.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Participants use the Donor App to create and share their story via social media to identify potential live donors

Indefinite

Follow-up

Participants are monitored for the success of the Donor App in identifying live donors and facilitating live donor transplantation

Up to 5 years

Treatment Details

Interventions

• The Donor App

Trial Overview The study is testing 'The Donor App', which is designed to help patients in need of an organ transplant use social media to find living donors and allows potential donors to start the evaluation process.

Participant Groups

Group I: The Donor App Experimental Treatment 1 Intervention

Select physicians and research staff from about 15 transplant hospitals will be given access to distribute the application to patients who the above people feel could benefit from the application. After obtaining informed consent, an approved member of the study team will enter the participant's name, contact info, and organ needed into the Donor App's secure management portal to send an email or text message with a unique and protected invitation link to the participant. Using this link the participant will be allowed to use the Donor App indefinitely.

The Donor App is already approved in United States for the following indications:

Approved in United States as DONOR for:

• Organ transplant waitlist management
• Living donor identification

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Rush University Medical Center

Collaborator

Trials

448

Recruited

247,000+

Scripps Health

Collaborator

Trials

59

Recruited

43,400+

Yale University

Collaborator

Trials

1,963

Recruited

3,046,000+

Washington University School of Medicine

Collaborator

Trials

2,027

Recruited

2,353,000+

MaineHealth

Collaborator

Trials

76

Recruited

43,800+

Findings from Research

A prototype mobile health (mHealth) system for kidney transplant patients significantly improved medication adherence and reduced systolic blood pressure compared to standard care, demonstrating its potential effectiveness in managing hypertension.

The system was found to be safe and highly acceptable among patients and providers, with a high retention rate of 91% during the 3-month trial involving 20 participants, indicating strong feasibility for future larger studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile Health Medication Adherence and Blood Pressure Control in Renal Transplant Recipients: A Proof-of-Concept Randomized Controlled Trial. McGillicuddy, JW., Gregoski, MJ., Weiland, AK., et al.[2022]

A telehealth app developed for kidney transplant follow-up was found to be easy to use and valuable for both patients and healthcare professionals, enhancing communication and support during post-transplant care.

The app facilitated better preparation and dialogue in consultations, indicating its potential to improve patient outcomes and collaboration in clinical practice, although further adjustments and investigations are needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a telehealth solution developed to improve follow-up after kidney Transplantation. Nielsen, C., Agerskov, H., Bistrup, C., et al.[2020]

Out of 823 downloads of the renal health application, only 12.3% were registered kidney transplant recipients, indicating limited engagement with the app among this population.

Although the app generated interest, with 36.7% of users entering health data like weight and creatinine levels, most users only engaged for a short time, highlighting challenges in long-term adherence to mHealth technologies in kidney transplantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the use of a Renal Health application by kidney transplant recipients. Oliveira, JGR., Sanders-Pinheiro, H., Freitas Filho, RA., et al.[2023]

The NefroPortatil mobile app significantly improved self-management of chronic kidney disease in 52 dialysis patients over a 3-month period, as indicated by a notable change in the Perceived Medical Condition Self-Management Scale (P < 0.03).

Laboratory results showed a significant reduction in serum phosphorus levels (P < 0.04) after using the app, suggesting it effectively aids in nutritional control for patients undergoing dialysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Validation of an Application for Follow-up of Patients Undergoing Dialysis: NefroPortátil. Pinto, LCS., Andrade, MC., Chaves, RO., et al.[2021]

The SMASK intervention, a mobile health self-management system, aims to improve medication adherence and blood pressure control in kidney transplant recipients, with a study involving 80 participants over 6 months.

If successful, SMASK could lead to better health outcomes for kidney transplant recipients and set the stage for larger studies to confirm its effectiveness in real-world settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Smartphone Medication Adherence Saves Kidneys" for Kidney Transplantation Recipients: Protocol for a Randomized Controlled Trial. McGillicuddy, J., Chandler, J., Sox, L., et al.[2020]

In a 1-year study involving 182 outpatients with advanced chronic kidney disease (CKD), the eKidneyCare app significantly reduced medication discrepancies compared to the MyMedRec app, indicating better medication management.

eKidneyCare not only lowered the total number of discrepancies but also reduced the severity of clinically relevant discrepancies, including those that could potentially cause serious harm, highlighting its effectiveness in improving medication safety for high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital Applications Targeting Medication Safety in Ambulatory High-Risk CKD Patients: Randomized Controlled Clinical Trial. Ong, SW., Jassal, SV., Porter, EC., et al.[2023]

Out of 543 serious adverse events reported in organ donation from 2016 to 2022, 53 cases (9.8%) were identified as proven or probable transmissions of diseases to recipients, highlighting the importance of monitoring disease transmission in organ transplantation.

Infections were the most common type of disease transmission, and the mortality rate among recipients who received infected organs was notably high at 23%, with a particularly alarming 50% mortality rate when malignant diseases were transmitted.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vigilance Data in Organ Donation and Solid Organ Transplantation in Germany: Six Years of Experience 2016-2022. Böhler, K., Rahmel, A., Barreiros, AP.[2023]

In a study of 267 predialysis patients with chronic kidney disease (CKD), 69.3% experienced at least one adverse safety event, highlighting the high risk of complications in this population.

The most common adverse events reported were hypoglycemia in diabetic patients and hyperkalemia (high potassium levels), with significant co-occurrences of these events, indicating a need for better safety monitoring in CKD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported and actionable safety events in CKD. Ginsberg, JS., Zhan, M., Diamantidis, CJ., et al.[2021]

A smartphone-based application was developed to predict kidney transplant survival for patients with End-Stage Renal Disease, utilizing data from 513 patient records and achieving an accuracy of 87.21% with the C5.0 data mining algorithm.

The application received positive usability ratings from urologists and nephrologists, indicating it is user-friendly and can be reliably used to assist in predicting graft survival in kidney transplantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predicting the survival of kidney transplantation: design and evaluation of a smartphone-based application. Shahmoradi, L., Borhani, A., Langarizadeh, M., et al.[2022]

Technology-based interventions (TBI) can significantly enhance awareness and knowledge about living donor kidney transplantation (LDKT), particularly among African American and Hispanic populations, which have seen a decline in LDKT rates.

In a review of 31 studies, 60% of patient-facing TBIs and 75% of donor-facing TBIs showed increased linkage between potential donors and transplant candidates, indicating that customized and accessible TBI can effectively connect these groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of technology-based interventions on linking potential kidney donors and transplant candidates: a scoping review. Deshpande, PP., Jariwala, S., Martin, L., et al.[2022]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Mobile Health Medication Adherence and Blood Pressure Control in Renal Transplant Recipients: A Proof-of-Concept Randomized Controlled Trial. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Evaluation of a telehealth solution developed to improve follow-up after kidney Transplantation. [2020]

3. Brazil pubmed.ncbi.nlm.nih.gov

Evaluation of the use of a Renal Health application by kidney transplant recipients. [2023]

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

Development and Validation of an Application for Follow-up of Patients Undergoing Dialysis: NefroPortátil. [2021]

5. Canada pubmed.ncbi.nlm.nih.gov

"Smartphone Medication Adherence Saves Kidneys" for Kidney Transplantation Recipients: Protocol for a Randomized Controlled Trial. [2020]

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

Digital Applications Targeting Medication Safety in Ambulatory High-Risk CKD Patients: Randomized Controlled Clinical Trial. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Vigilance Data in Organ Donation and Solid Organ Transplantation in Germany: Six Years of Experience 2016-2022. [2023]

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

Patient-reported and actionable safety events in CKD. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Predicting the survival of kidney transplantation: design and evaluation of a smartphone-based application. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Impact of technology-based interventions on linking potential kidney donors and transplant candidates: a scoping review. [2022]