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

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. ^{1 2 3 4 5}

Is 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. ^{1 2 3 6 7}

How 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. ^{1 3 8 9 10}

Eligibility 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.

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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 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 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]

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]

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]

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]

References

1. Brazil pubmed.ncbi.nlm.nih.gov

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

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

MyKidneyCoach, Patient Activation, and Clinical Outcomes in Diverse Kidney Transplant Recipients: A Randomized Control Pilot Trial. [2023]

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

Preferred Features in Mobile Health Applications for Kidney Transplant Recipients: A Qualitative Approach. [2021]

4. 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]

5. England pubmed.ncbi.nlm.nih.gov

Effectiveness of IT-based interventions on self-management in adult kidney transplant recipients: a systematic review. [2021]

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

Transplant surgery enters a new era: Increasing immunosuppressive medication adherence through mobile apps and smart watches. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Current state of mobile health apps in endourology: a review of mobile platforms in marketplaces and literature. [2023]

8. England pubmed.ncbi.nlm.nih.gov

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

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

An Exploratory Correlational Study in the Use of Mobile Technology Among Adult Kidney Transplant Recipients. [2019]

10. England 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. [2019]