mHealth App for Kidney Transplant Care

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medical University of South Carolina

Disqualifiers: Non-kidney transplant, Inability to use app, others

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

Duration: 2 years

190 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a smartphone app designed to help kidney transplant patients manage medications and monitor health. The study aims to determine if the app can improve health outcomes, particularly for African American patients. Participants will either use the app or receive regular care without it. Those who have had a kidney transplant for over two years and can use the app and track their health might be a good fit. As an unphased trial, this study offers patients the chance to contribute to innovative research that could enhance post-transplant care.

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 prior data suggests that this mHealth app is safe for kidney transplant care?

Research has shown that mobile health (mHealth) apps, like the one tested in this trial, are generally safe and easy to use. One study found that an mHealth app helped kidney transplant patients remember to take their medications on time and lowered their systolic blood pressure, the top number in a blood pressure reading.

Another study found that a similar app, when used with a pharmacist's assistance, saved money by reducing hospital visits. This suggests that these apps not only help manage health but are also safe to use.

Overall, no serious side effects or safety concerns have been reported with mHealth apps in these situations, which is reassuring for those considering joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the mHealth app for kidney transplant care because it offers a new way to support patients beyond the traditional methods like medication management and routine clinic visits. Unlike standard care, which often relies on in-person follow-ups, this app provides continuous, remote monitoring and personalized health insights. By integrating telehealth features, it allows for real-time communication and data sharing between patients and healthcare providers, which could potentially improve adherence to treatment protocols and overall outcomes. This approach aims to make post-transplant care more accessible and efficient, promising to enhance patient engagement and quality of life.

What evidence suggests that this mHealth app is effective for improving care in kidney transplant patients?

Research shows that mobile health (mHealth) apps can help kidney transplant patients manage their health more effectively. In this trial, participants in the intervention group will use an mHealth app alongside usual care. Studies have found that these apps assist with tracking medications, managing diet, and following self-care routines. For those who have had a kidney transplant, using a mobile app can help better control blood pressure and blood sugar levels, which is especially important for patients with diabetes. Research also indicates that many kidney transplant patients are willing to use mHealth apps, which can improve their involvement in their own care and lead to better health outcomes after the transplant. Overall, these apps have the potential to enhance the care and health of kidney transplant patients. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• mHealth app/dashboard

Trial Overview 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.

How Is the Trial Designed?

Group I: Intervention Group Experimental Treatment 1 Intervention

Usual Care + mHealth/Telehealth

Group II: Control Group Active Control 1 Intervention

Usual Care + Attention Control

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

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

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

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]

The MyKidneyCoach app was well-accepted by kidney transplant recipients, showing a high completion rate of 81% and a retention rate of 73%, indicating its feasibility as a self-management tool.

Participants using MyKidneyCoach experienced significant improvements in patient activation and self-management skills, particularly among Black patients, suggesting that this intervention could help address healthcare disparities in kidney transplant outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MyKidneyCoach, Patient Activation, and Clinical Outcomes in Diverse Kidney Transplant Recipients: A Randomized Control Pilot Trial. Pollock, MD., Stauffer, N., Lee, HJ., et al.[2023]

A review of 986 mobile healthcare apps related to kidney stone disease identified 83 that were analyzed, revealing a significant focus on fluid tracking (54 apps) but insufficient physician involvement in their development and data security measures.

Despite the availability of various apps for education and management of kidney stone disease, there is a critical need for better regulation and oversight to ensure their accuracy, safety, and adherence to FDA and Medical Device Regulation guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current state of mobile health apps in endourology: a review of mobile platforms in marketplaces and literature. Talyshinskii, A., Bakhman, G., Hameed, BZ., et al.[2023]

IT-based interventions, such as mobile health applications and computer systems, significantly improve self-management in kidney transplant recipients, with 80% of evaluated outcomes showing positive effects.

While these interventions positively impacted care processes and some clinical outcomes, further studies are needed to fully understand their long-term effects on clinical outcomes, healthcare costs, and patients' quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of IT-based interventions on self-management in adult kidney transplant recipients: a systematic review. Eslami, S., Khoshrounejad, F., Golmakani, R., et al.[2021]

A mobile health (mHealth) app was developed to aid in the early diagnosis and self-monitoring of chronic kidney disease (CKD), with a substantial agreement (Kappa value of 0.7119) between the app's results and assessments from three nephrologists based on 60 medical records.

User testing indicated good satisfaction with the app, although many users struggled to understand specific biomarkers, highlighting the need for better education on CKD indicators to enhance self-monitoring effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design and evaluation of a mobile application to assist the self-monitoring of the chronic kidney disease in developing countries. Sobrinho, A., da Silva, LD., Perkusich, A., et al.[2019]

A study involving kidney transplant recipients tested the effectiveness of a mobile app, Transplant Hero, and a smartwatch in improving adherence to immunosuppressive medication, but found no significant differences in tacrolimus level variability among the groups after one and three months.

While mobile health technology shows potential for enhancing patient engagement and education, this study indicates that more research is needed to optimize its use for improving medication adherence in transplant patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transplant surgery enters a new era: Increasing immunosuppressive medication adherence through mobile apps and smart watches. Levine, D., Torabi, J., Choinski, K., et al.[2020]

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]

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]

A study of 123 kidney transplant recipients found that those using mHealth apps had significantly fewer hospitalizations compared to both other app users and non-app users, suggesting that these apps may enhance self-management and reduce health complications.

Knowledge barriers were a major issue for non-app users, with 49% reporting lack of knowledge as a reason for not using mHealth apps, highlighting the need for better education on these tools.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Exploratory Correlational Study in the Use of Mobile Technology Among Adult Kidney Transplant Recipients. O'Brien, T., Russell, CL., Tan, A., et al.[2019]

Kidney transplant recipients find mHealth apps useful for real-time health tracking, including medication, nutrition, fluid intake, lab values, and activity, which can enhance their self-care management.

Key features that improve the usability of these apps include personalized feedback, easy-to-read formats, and centralized information storage, making it easier for users to engage with their health data.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preferred Features in Mobile Health Applications for Kidney Transplant Recipients: A Qualitative Approach. O'Brien, T., Rosenthal, A.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05151445?tab=results

The Use of a Consumer-Based mHealth Dietary App and ... A feasibility study will be utilized to establish the recruitment, retention, and adherence with post-kidney transplant recipients using a consumer-based ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4968877/

Kidney transplant recipients' attitudes about using mobile ... The results of this study provide continued evidence that the majority of kidney transplant recipients now own smartphones and are willing to use mHealth apps ...

3. jmir.org jmir.org/2025/1/e53144/PDF

Effectiveness of Mobile Apps in Improving Medication ... Kidney Love is a mobile app designed to assist kidney transplant recipients in improving self-management through dietary restrictions, blood ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8966961/

Review and Evaluation of mHealth Apps in Solid Organ ... In conclusion, mHealth systems show promise in improving patient engagement and self-management in solid organ transplantation. To gain ...

5. docwirenews.com docwirenews.com/post/mobile-health-app-to-track-self-care-post-transplant

Mobile Health App to Track Self-Care Post-Transplant mHealth apps has presented an opportunity for kidney transplant recipients to manage their post-transplant requirements, set goals, and monitor self-care ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S1600613522087615

Significant hospitalization cost savings to the payer with a ... A mHealth-enabled, pharmacist-led intervention significantly reduced hospitalization costs for payers over a 12-month period and has a positive ROI.

7. mhealth.jmir.org mhealth.jmir.org/2023/1/e45531/

Improving Kidney Outcomes in Patients With Nondiabetic ... Conclusions: The utilization of the KidneyOnline intelligent care system was associated with reduced risk of unfavorable kidney outcomes in ...