The Donor App for Kidney Failure
Recruiting in Palo Alto (17 mi)
+5 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Johns Hopkins University
Disqualifiers: Under 18, Multiple organ lists
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
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.
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.
12345Is 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.
35678How 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.
345910Eligibility 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 18 years old or older.
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.
Trial 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
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: The Donor AppExperimental Treatment1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
The Johns Hopkins HospitalBaltimore, MD
Scripps Green HospitalSan Diego, CA
Washington University in St. LouisSaint Louis, MO
Maine Medical CenterPortland, ME
More Trial Locations
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Who Is Running the Clinical Trial?
Johns Hopkins UniversityLead Sponsor
Rush University Medical CenterCollaborator
Scripps HealthCollaborator
Yale UniversityCollaborator
Washington University School of MedicineCollaborator
MaineHealthCollaborator
References
Mobile Health Medication Adherence and Blood Pressure Control in Renal Transplant Recipients: A Proof-of-Concept Randomized Controlled Trial. [2022]Mobile phone based programs for kidney transplant recipients are promising tools for improving long-term graft outcomes and better managing comorbidities (eg, hypertension, diabetes). These tools provide an easy to use self-management framework allowing optimal medication adherence that is guided by the patients' physiological data. This technology is also relatively inexpensive, has an intuitive interface, and provides the capability for real-time personalized feedback to help motivate patient self-efficacy. Automated summary reports of patients' adherence and blood pressure can easily be uploaded to providers' networks helping reduce clinical inertia by reducing regimen alteration time.
Evaluation of a telehealth solution developed to improve follow-up after kidney Transplantation. [2020]To explore patients' and healthcare professionals' experiences of using a telehealth solution developed to improve follow-up after kidney transplantation.
Evaluation of the use of a Renal Health application by kidney transplant recipients. [2023]to evaluate the use of a renal health application by kidney transplant recipients.
Development and Validation of an Application for Follow-up of Patients Undergoing Dialysis: NefroPortátil. [2021]To develop the NefroPortatil mobile application (app) and evaluate its effects on the management of patients undergoing dialysis.
"Smartphone Medication Adherence Saves Kidneys" for Kidney Transplantation Recipients: Protocol for a Randomized Controlled Trial. [2020]Kidney transplant recipients' poor medication adherence and poor control of comorbidities, particularly hypertension, are risk factors for graft rejection, graft loss, and death. Few randomized controlled trials (RCTs) have been successful in improving sustained medication adherence and blood pressure control among kidney transplantation recipients. We provide rationale for an RCT evaluating a mobile health medical self-management system for kidney transplantation recipients called Smartphone Medication Adherence Saves Kidneys (SMASK).
Digital Applications Targeting Medication Safety in Ambulatory High-Risk CKD Patients: Randomized Controlled Clinical Trial. [2023]Patients with CKD are at risk for adverse drug reactions, but effective community-based preventive programs remain elusive. In this study, we compared the effectiveness of two digital applications designed to improve outpatient medication safety.
Vigilance Data in Organ Donation and Solid Organ Transplantation in Germany: Six Years of Experience 2016-2022. [2023]The reporting of serious adverse events (SAE) and serious adverse reactions (SAR) is an essential part of an effective vigilance and surveillance system (V&S) in organ donation and transplantation. All SAE and SAR reported to the German organ procurement organization (DSO) between 2016 and 2022 were analyzed. In case of a possible transmission of a disease to one or more recipients, an assessment of imputability was done according to the grading system of the US Disease Transmission Advisory Committee (DTAC). 543 SAE and SAR cases were reported to the DSO and analyzed in detail. 53 of the 543 reports (9.8%) were proven or probable (P/P) transmissions of infectious diseases, malignancies or other diseases to 75 recipients. Infections were the most frequently reported P/P disease transmission occurrences (30/53, 57%). In case of disease transmission, the mortality of the recipients was high (17/75, 23%), especially when a malignant disease was transmitted (11/22, 50 %). Donor-Derived disease transmission is a rare event (53/8,519; 0.6 %), but when it occurs can lead to significant morbidity and mortality.
Patient-reported and actionable safety events in CKD. [2021]Patients with CKD are at high risk for adverse safety events because of the complexity of their care and impaired renal function. Using data from our observational study of predialysis patients with CKD enrolled in the Safe Kidney Care study, we estimated the baseline frequency of adverse safety events and determined to what extent these events co-occur. We examined patient-reported adverse safety incidents (class I) and actionable safety findings (class II), conditioned on participant use of drugs that might cause such an event, and we used association analysis as a data-mining technique to identify co-occurrences of these events. Of 267 participants, 185 (69.3%) had at least one class I or II event, 102 (38.2%) had more than one event, and 48 (18.0%) had at least one event from both classes. The adjusted conditional rates of class I and class II events ranged from 2.9 to 57.6 per 100 patients and from 2.2 to 8.3 per 100 patients, respectively. The most common conditional class I and II events were patient-reported hypoglycemia and hyperkalemia (serum potassium>5.5 mEq/L), respectively. Reporting of hypoglycemia (in patients with diabetes) and falling or severe dizziness (in patients without diabetes) were most frequently paired with other adverse safety events. We conclude that adverse safety events are common and varied in CKD, with frequent association between disparate events. Further work is needed to define the CKD "safety phenotype" and identify patients at highest risk for adverse safety events.
Predicting the survival of kidney transplantation: design and evaluation of a smartphone-based application. [2022]Prediction of graft survival for Kidney Transplantation (KT) is considered a risky task due to the scarcity of donating organs and the use of health care resources. The present study aimed to design and evaluate a smartphone-based application to predict the survival of KT in patients with End-Stage Renal Disease (ESRD).
Impact of technology-based interventions on linking potential kidney donors and transplant candidates: a scoping review. [2022]Despite the demonstrated survival advantage in end-stage kidney disease (ESKD) patients of a preemptive living donor kidney transplantation (LDKT), there has been a decline in LDKT among African American and Hispanic populations. We performed a scoping review and summarized the evidence about the use of technology-based interventions (TBI) to not only increase knowledge and awareness of LDKT but also link living donors with transplant candidates. We evaluated 31 studies and characterized them into "transplant-candidate facing" TBI, "transplant donor facing" TBI, and "interactive websites" targeting both donors and candidates. For the patient-facing interventions, 60% of studies suggested an increased likelihood of linking possible donors and candidates. The donor-facing interventions showed an increase in donor awareness and 75% of these interventions suggested increasing donor-candidate linkage. This study also demonstrates that TBI (regardless of medium) that are accessible and customized to the specific target population can potentially increase linkage of donors to recipients and serve as effective guides to connect potential donors to transplant candidates.