mHealth Messaging for Transplant Medication Adherence

Overseen By Cyd Eaton, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Must be taking: Tacrolimus, Sirolimus

Disqualifiers: Dialysis, Hospitalized, Cognitive delay, others

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

Compensation: Varies

Number of Visits: Unknown

65 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether text message reminders can help young people adhere to their medication schedule after a kidney or liver transplant. The focus is on improving adherence to immunosuppressants, which are crucial for maintaining the health of the transplanted organ. Participants will use electronic pill boxes to track their medication intake, and some will receive text messages based on their adherence. Known as the mHealth Messaging Intervention Group, this trial is suitable for individuals aged 13-25 who had a kidney or liver transplant at least six months ago and are taking specific medications like tacrolimus or sirolimus. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance post-transplant care for young people.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it requires participants to be on tacrolimus or sirolimus. If you are already taking these, you will likely continue them during the study.

What prior data suggests that this mHealth Messaging Intervention is safe for improving medication adherence?

Research has shown that mobile health tools, such as text messages and electronic pillboxes, are generally safe and easy for people to use. These tools help patients adhere to their medication schedules without causing harm. A review of studies involving over 3,000 transplant patients found that these tools improved medication adherence.

Furthermore, reviews of mobile health apps for transplant patients have identified no major safety issues, indicating these digital tools are safe. Participants in the mHealth Messaging Intervention can expect a low risk of side effects while potentially improving their medication habits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the mHealth Messaging Intervention because it offers a fresh approach to improving medication adherence for transplant patients. Unlike traditional methods that rely heavily on patients remembering to take their medication, this intervention uses electronic pill boxes to track adherence and sends personalized text messages. These messages either encourage patients after missed doses or praise them for taking their medication on time. This innovative use of technology aims to enhance patient engagement and ensure better health outcomes by providing timely support and motivation directly to patients' phones.

What evidence suggests that this mHealth Messaging Intervention is effective for improving medication adherence in transplant patients?

Research has shown that mobile health tools, such as text reminders and electronic pillboxes, can help people take their medication as prescribed. In this trial, participants will join a mobile health (mHealth) text messaging intervention, with adherence monitored through electronic pillboxes. For instance, one study found that these tools helped kidney transplant patients take their anti-rejection medication on time, which is crucial to prevent organ rejection. Reviews suggest that mobile health tools effectively support regular medication use in managing long-term health conditions. Overall, evidence indicates that these digital tools offer a promising way to help patients maintain their medication schedules. ^{3 6 7 8 9}

Who Is on the Research Team?

Cyd Eaton, PhD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for young people aged 13-25 who had a kidney or liver transplant at least 6 months ago and are taking specific anti-rejection drugs (tacrolimus or sirolimus).

Inclusion Criteria

I am currently taking tacrolimus or sirolimus.

I am between 13-25 years old and had a kidney or liver transplant over 6 months ago.

Exclusion Criteria

Non-English speaking

Hospitalized for duration of study

Decline to use electronic pill box to monitor daily medication adherence

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Monitoring

Adherence is monitored daily via electronic pill boxes without sending text messages

4 weeks

Daily monitoring (remote)

Micro-randomized Trial

Participants receive adherence support or praise text messages based on their dosing behavior

12 weeks

Daily monitoring (remote)

Follow-up

Participants continue using electronic pill boxes for adherence monitoring without text messages

12 months

Monthly check-ins (remote)

What Are the Treatments Tested in This Trial?

Interventions

• mHealth Messaging Intervention Group

Trial Overview

The study tests if a mobile tech intervention with electronic pillbox monitoring and text message reminders can help these patients take their medication on time to prevent organ rejection.

How Is the Trial Designed?

Group I: Mobile health (mHealth) text messaging intervention Experimental Treatment 1 Intervention

During baseline (4 weeks), adherence will be monitored daily via electronic pill boxes and no text messages will be sent. After baseline, participants will begin the 12-week micro-randomized trial of the intervention (a within-person study design). During this 12-week micro-randomized trial, daily adherence will be electronically monitored with the electronic pill boxes and participants will be randomized to receive (1) adherence support text messages or (2) no text message after each missed dose, and (1) praise text message or (2) no text message after each on time dose. For 12 months post-intervention, participants will keep using the electronic pill boxes (no text messages will be sent).

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

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 study involving 41 pediatric liver transplant patients showed that using text message reminders significantly improved adherence to immunosuppressant medication, as indicated by a decrease in the standard deviation of serum tacrolimus levels from 3.46 microg/L to 1.37 microg/L.

The number of acute cellular rejection episodes dropped dramatically from 12 to 2 during the study, highlighting the effectiveness of text messaging in enhancing medication adherence and reducing rejection risks in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved adherence and outcomes for pediatric liver transplant recipients by using text messaging. Miloh, T., Annunziato, R., Arnon, R., et al.[2022]

A meta-analysis of 16 randomized clinical trials involving 2742 patients found that mobile phone text messaging significantly improves medication adherence in adults with chronic diseases, doubling the odds of adherence (odds ratio of 2.11).

The increase in adherence rates from approximately 50% to 67.8% suggests that text messaging can be an effective and scalable intervention, although results should be interpreted cautiously due to the reliance on self-reported data and the short duration of the studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile Telephone Text Messaging for Medication Adherence in Chronic Disease: A Meta-analysis. Thakkar, J., Kurup, R., Laba, TL., et al.[2022]

An integrative review of 13 studies found that using text messages to promote medication adherence improved adherence rates by 15.3% to 17.8%, highlighting their potential as an effective intervention.

The review suggests that standardized, tailored, and timely text messages can enhance medication adherence across various diseases, but emphasizes the need for larger, rigorous randomized trials to further validate these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

mHealth SMS text messaging interventions and to promote medication adherence: an integrative review. DeKoekkoek, T., Given, B., Given, CW., et al.[2022]

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]

The mHeart app, developed for heart transplant recipients, showed high acceptance among patients, with 97.7% of the 135 participants willing to use the system, indicating strong potential for improving therapy management and patient-provider interactions.

The implementation of the mHeart model faced challenges such as ensuring data confidentiality and increasing interoperability, but the interdisciplinary approach and stakeholder involvement were crucial for its development and scalability in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interdisciplinary Mobile Health Model to Improve Clinical Care After Heart Transplantation: Implementation Strategy Study. Gomis-Pastor, M., Mirabet, S., Roig, E., et al.[2020]

A systematic review of seven randomized controlled trials involving 759 organ transplant patients found that eHealth interventions did not significantly improve medication adherence compared to standard care, with effect sizes ranging from -0.18 to 1.30.

Despite the lack of significant differences in adherence and knowledge scores, the study suggests that eHealth interventions can still be considered for supporting medication adherence in organ transplant patients, highlighting the need for further research to enhance these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of eHealth interventions for improving medication adherence of organ transplant patients: A systematic review and meta-analysis. Lee, H., Shin, BC., Seo, JM.[2021]

In a study of 90 kidney and liver transplant recipients using the TrackYourMed® (TYM) app, 68% regularly engaged with the mobile health technology to track their immunosuppression adherence, indicating a promising level of patient engagement.

The study found that higher rates of medication taken out of schedule were linked to greater variability in drug levels and more frequent dose adjustments, suggesting that TYM can help identify patients with erratic adherence, potentially improving transplantation outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adoption of a novel smart mobile-health application technology to track chronic immunosuppression adherence in solid organ transplantation: Results of a prospective, observational, multicentre, pilot study. Melilli, E., Cestone, G., Revuelta, I., et al.[2021]

A pharmacist-led, mobile health-based intervention significantly reduced medication errors by 61% and decreased the incidence of severe adverse events in kidney transplant recipients, based on a study of 136 participants over 12 months.

The intervention also led to a notable reduction in hospitalizations, indicating that improving medication safety can enhance overall patient outcomes in kidney transplant care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacist-Led Mobile Health Intervention and Transplant Medication Safety: A Randomized Controlled Clinical Trial. Gonzales, HM., Fleming, JN., Gebregziabher, M., et al.[2023]

The study involved 205 adult transplant recipients and demonstrated that a tailored behavioral intervention significantly improved medication adherence, with a 16% increase in dosing adherence in the intervention group compared to the control group (95.1% vs 79.1%; p < 0.001).

Although the intervention improved adherence, the 5-year clinical event-free survival rates were 82.5% for the intervention group and 72.5% for the control group, indicating a trend towards better outcomes, but not statistically significant (p = 0.18).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a medication adherence enhancing intervention in transplantation: The MAESTRO-Tx trial. Dobbels, F., De Bleser, L., Berben, L., et al.[2022]

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]

Mobile health applications (m-Health apps) have been shown to improve medication adherence and self-management in transplant patients, with 62.5% of studies indicating positive outcomes in these areas.

The systematic review highlighted that 37.5% of the studies focused on lung transplantation, emphasizing the importance of m-Health in managing post-transplant care, which is crucial for preventing medication nonadherence and subsequent graft loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of mobile health-based self-management application for posttransplant cares: A systematic review. Abasi, S., Yazdani, A., Kiani, S., et al.[2022]

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mHealth Messaging for Transplant Medication Adherence

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