mHealth App for Kidney Transplant Care
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Medical University of South Carolina
Disqualifiers: Non-kidney transplant, Inability to use app, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?This is a randomized study to test a smartphone app that a pharmacist will use to help kidney transplant patients track their medications, blood pressures, and blood sugars in those with diabetes. The goal of this study is to improve care and outcomes in kidney transplant patients and, in particular, help African American patients have better outcomes after transplant.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It seems likely that you can continue your current medications, as the study involves tracking them with an app.
What data supports the effectiveness of the mHealth app/dashboard treatment for kidney transplant care?
Research shows that mobile health apps can help kidney transplant patients manage their health better by improving medication adherence, blood pressure control, and self-management skills. These apps provide real-time feedback and personalized coaching, which can lead to better engagement and health outcomes.
12345Is the mHealth app for kidney transplant care safe for humans?
The research on mHealth apps for kidney transplant care does not specifically address safety concerns, but it highlights the importance of data security and the need for proper development and regular updates to ensure safe use.
12367How is the mHealth app for kidney transplant care different from other treatments?
The mHealth app for kidney transplant care is unique because it uses mobile technology to help patients monitor their self-care in real time, offering features like health tracking, personalized feedback, and easy usability. Unlike traditional treatments, this app provides a platform for patients to actively engage in their health management, which can be more convenient and accessible.
138910Eligibility Criteria
This trial is for kidney transplant patients who are at least 18 years old and two or more years post-transplant. It's focused on helping African American patients in particular. Participants must be able to measure their own blood pressure and glucose if diabetic, use a mobile health app after training, and speak, hear, and read English.Inclusion Criteria
It has been over 2 years since my kidney transplant.
I am 18 years old or older.
Exclusion Criteria
Not capable of speaking, hearing, and reading English
I have received an organ transplant, but it was not a kidney.
I cannot measure my own blood pressure or glucose levels.
+1 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants use a smartphone app to track medications, blood pressures, and blood sugars, with pharmacist support
2 years
Monthly visits (in-person or virtual)
Follow-up
Participants are monitored for safety and effectiveness after treatment
6 months
Participant Groups
The study is testing a smartphone app managed by pharmacists that helps track medications, blood pressures, and blood sugars for those with diabetes. The aim is to see if this mHealth tool can improve medication adherence and overall outcomes after kidney transplants.
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention GroupExperimental Treatment1 Intervention
Usual Care + mHealth/Telehealth
Group II: Control GroupActive Control1 Intervention
Usual Care + Attention Control
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Medical University of South CarolinaCharleston, SC
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Who Is Running the Clinical Trial?
Medical University of South CarolinaLead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Collaborator
References
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.
MyKidneyCoach, Patient Activation, and Clinical Outcomes in Diverse Kidney Transplant Recipients: A Randomized Control Pilot Trial. [2023]Kidney transplant (KT) recipients who are not actively engaged in their care and lack self-management skills have poor transplant outcomes, which are disproportionately observed among Black KT recipients. This pilot study aimed to determine whether the MyKidneyCoach app, an mHealth intervention that provides self-management monitoring and coaching, improved patient activation, engagement, and nutritional behaviors in a diverse KT population.
Preferred Features in Mobile Health Applications for Kidney Transplant Recipients: A Qualitative Approach. [2021]Despite the increasing number of consumer-based mobile health applications (mHealth apps) for self-care, there is little research exploring consumers' experiences with mHealth apps. Health apps using mobile technology have the potential to provide a platform for kidney transplant recipients to monitor their self-care in real time. This study explored kidney transplant recipients' perceptions of the usefulness of mHealth apps and identified features that Kidney transplant recipients believe are important for using mHealth apps. A qualitative design was used to explore a purposive sample of adult kidney transplant recipients from a Midwest Transplant Program who used an mHealth app. Qualitative content data analysis revealed three themes participants found useful: health tracking (medication, nutrition, fluid intake, lab values, and activity), feedback (short personalized messages, positive awards using symbols, and color-coded bar graphs indicating normal and abnormal ranges), and usability (large font, words that everyone can understand, and all information stored in one area).
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.
Effectiveness of IT-based interventions on self-management in adult kidney transplant recipients: a systematic review. [2021]Kidney transplant outcomes are broadly associated with transplant recipients' capacity in following a complex and continuous self-management regimen. Health information technology has the potential to empower patients. This systematic review aimed to determine the impacts of IT-based interventions for self-management in kidney transplant recipients.
Transplant surgery enters a new era: Increasing immunosuppressive medication adherence through mobile apps and smart watches. [2020]The high rate of immunosuppressive medication non-adherence in transplant recipients demands the search for a solution that targets modifiable risk factors and incorporates mobile health technology to better engage and educate patients. Kidney transplant recipients (kidneys alone or multi-organ) were randomized to receive a mobile app known as Transplant Hero, both the app and a smart watch, or neither. The coefficient of variability (CV) of tacrolimus levels was measured at one and three months. No statistically significant differences in CV levels were observed between the three groups at either one or three months. Although mobile health apps are a promising strategy for increasing medication adherence, further research is required to determine how to best use this technology.
Current state of mobile health apps in endourology: a review of mobile platforms in marketplaces and literature. [2023]Several mobile healthcare (mHealth) apps are available in various marketplaces, but there is still concern about their accuracy, data safety, and regulation. The goal of this review was to critically analyze the mobile apps created for education, diagnosis, and medical and surgical treatment of patients with kidney stone disease (KSD), as well as to assess the level of data security, the contribution of physicians in their development and adherence to the Food and Drug Administration (FDA) and Medical Device Regulation (MDR) guidance. A comprehensive literature search was performed using PubMed (September 2022), in the Apple App Store and Google Play store using relevant keywords and inclusion criteria. Information was extracted for the name of the app, primary and additional functionalities, release and last update, number of downloads, number of marks and average rating, Android/iOS compatibility, initial and in-app payments, data safety statement, physician involvement statement, and FDA/MDR guidance. A total of 986 apps and 222 articles were reviewed, of which based on the inclusion, 83 apps were finally analyzed. The apps were allocated to six categories about their primary purpose: education (n = 8), fluid trackers (n = 54), food content description and calculators (n = 11), diagnosis (n = 3), pre- and intra-operative application (n = 4), and stent trackers (n = 2). Of these apps, the number of apps supported for Android, iOS, and both of them were 36, 23, and 23, respectively. Despite a wide range of apps available for KSD, the participation of doctors in their development, data security, and functionality remains insufficient. Further development of mHealth should be carried out properly under the supervision of urological associations involving patient support groups, and these apps must be regularly updated for their content and data security.
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).
An Exploratory Correlational Study in the Use of Mobile Technology Among Adult Kidney Transplant Recipients. [2019]Rapidly growing use of mobile technology provides a platform for self-management of care support for those with chronic conditions. Few studies have explored the characteristics or access patterns of kidney transplant recipients who use mHealth applications (apps) for self-management of care.
Design and evaluation of a mobile application to assist the self-monitoring of the chronic kidney disease in developing countries. [2019]The chronic kidney disease (CKD) is a worldwide critical problem, especially in developing countries. CKD patients usually begin their treatment in advanced stages, which requires dialysis and kidney transplantation, and consequently, affects mortality rates. This issue is faced by a mobile health (mHealth) application (app) that aims to assist the early diagnosis and self-monitoring of the disease progression.