mHealth Messaging for Transplant Medication Adherence

Overseen By Cyd Eaton, PhD

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Johns Hopkins University

Must be taking: Tacrolimus, Sirolimus

Disqualifiers: Dialysis, Hospitalized, Cognitive delay, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

Can the investigators create an effective way to improve adherence to immunosuppressant medication and reduce rejection, graft loss, and death in adolescents and young adults who have undergone kidney or liver transplantation? The investigators' mobile technology intervention uses real-time electronic pillbox-assessed dose timing and text message prompts to address antirejection medication nonadherence when nonadherence is detected.

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 data supports the effectiveness of the mHealth Messaging Intervention treatment for transplant medication adherence?

Research suggests that mobile health (mHealth) interventions, like apps and electronic tools, show promise in improving medication adherence in organ transplant patients, although more studies are needed to determine the best ways to use this technology effectively. ^{1 2 3 4 5}

Is mHealth messaging safe for transplant medication adherence?

The research does not report any specific safety concerns related to using mobile health messaging for improving medication adherence in transplant patients. However, further studies are needed to fully understand the best ways to use this technology. ^{1 4 6 7 8}

How is the mHealth Messaging Intervention treatment different from other treatments for transplant medication adherence?

The mHealth Messaging Intervention is unique because it uses mobile phone text messages to remind patients to take their medication, which is a scalable and innovative way to improve adherence compared to traditional methods. This approach leverages technology to engage patients and support their self-management, which is particularly important for transplant recipients who need to maintain strict medication schedules. ^{1 4 9 10 11}

Research Team

Cyd Eaton, PhD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

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

Trial Timeline

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)

Treatment Details

Interventions

• mHealth Messaging Intervention Group (Behavioral Intervention)

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.

Participant Groups

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+

Findings from Research

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 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]

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 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 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]

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]

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]

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]

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]

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]

References

1. Canada pubmed.ncbi.nlm.nih.gov

"Smartphone Medication Adherence Saves Kidneys" for Kidney Transplantation Recipients: Protocol for a Randomized Controlled Trial. [2020]

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

Efficacy of a medication adherence enhancing intervention in transplantation: The MAESTRO-Tx trial. [2022]

3. Canada pubmed.ncbi.nlm.nih.gov

Interdisciplinary Mobile Health Model to Improve Clinical Care After Heart Transplantation: Implementation Strategy Study. [2020]

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

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

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

Effectiveness of eHealth interventions for improving medication adherence of organ transplant patients: A systematic review and meta-analysis. [2021]

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

Improved adherence and outcomes for pediatric liver transplant recipients by using text messaging. [2022]

7. Denmark 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. [2021]

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

Pharmacist-Led Mobile Health Intervention and Transplant Medication Safety: A Randomized Controlled Clinical Trial. [2023]

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

Effectiveness of mobile health-based self-management application for posttransplant cares: A systematic review. [2022]

10. England pubmed.ncbi.nlm.nih.gov

mHealth SMS text messaging interventions and to promote medication adherence: an integrative review. [2022]

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

Mobile Telephone Text Messaging for Medication Adherence in Chronic Disease: A Meta-analysis. [2022]