Mobile Video DOT for Heart Transplant Medication Adherence

Recruiting at 3 trial locations

Overseen By Dalia Lopez-Colon, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Florida

Disqualifiers: Cognitive impairments

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

100 Participants Needed

Trial Summary

What is the purpose of this trial?

We will conduct a two-group randomized controlled trial to examine the eMocha DOT intervention with pediatric HT recipients.In this population, medication nonadherence remains a primary cause of late acute rejection (LAR) episodes, increased number of hospitalizations, graft failure, and patient mortality. Herein, we propose an innovative approach to promote medication adherence and improve patient and graft outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on helping you stick to your existing heart transplant medication schedule.

What data supports the effectiveness of the treatment Mobile Video DOT for Heart Transplant Medication Adherence?

Research shows that using mobile health strategies, like the mHeart app, significantly improves medication adherence and patient experience in heart transplant recipients. The app helps patients remember to take their medication and understand its importance, leading to better health outcomes. ^{1 2 3 4 5}

Is Mobile Video DOT safe for use in humans?

Research on Mobile Video DOT, used for monitoring medication adherence in various conditions, shows it is generally safe and well-accepted by patients. Studies have found it feasible and effective in improving adherence without significant safety concerns. ^{2 3 6 7 8}

How is the Mobile Video DOT treatment different from other treatments for heart transplant medication adherence?

Mobile Video DOT is unique because it uses video technology to allow patients to record themselves taking their medication, which is then reviewed by healthcare providers to ensure adherence. This approach combines direct observation with mobile health technology, making it more interactive and engaging compared to traditional methods. ^{1 2 3 6 9}

Research Team

Dipankar Gupta, MD

Principal Investigator

University of Florida

Eligibility Criteria

This trial is for heart transplant recipients aged 10-21 who speak English or Spanish, have a history of medication nonadherence, and own or can access a smartphone. They must be monitored by participating centers and willing to use an app. Those with cognitive impairments cannot join.

Inclusion Criteria

Participants own a smart-phone or have access to the mobile app through other devices

Participants are willing to receive information through it

Participants have a MLVI score of greater than 2.0 over the last year

Exclusion Criteria

I have difficulties with memory or thinking clearly.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the eMocha DOT intervention or standard of care for medication adherence

12 weeks

Regular virtual check-ins via the eMocha app

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Periodic assessments and hospitalizations tracking

Treatment Details

Interventions

• DOT intervention

Trial Overview The study tests the eMocha DOT (Directly Observed Therapy) mobile video intervention aimed at improving medication adherence in young heart transplant patients to reduce rejection episodes and improve survival rates.

Participant Groups

Group I: eMocha intervention Experimental Treatment 1 Intervention

Adolescent patients randomized to the use of asynchronous mobile video directly observed therapy (DOT) intervention (eMocha DOT app)

Group II: Standard of care Active Control 1 Intervention

Adolescent patients who continue enhanced goal-setting standard of care

DOT intervention is already approved in United States, European Union for the following indications:

Approved in United States as Video DOT for:

• Immunosuppression in adolescent heart transplant recipients

Approved in European Union as vDOT for:

• Immunosuppression in adolescent heart transplant recipients

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

emocha Mobile Health, Inc.

Collaborator

Trials

3

Recruited

340+

Findings from Research

The mHealth strategy using the mHeart mobile application significantly improved medication adherence in heart transplant recipients, with adherence rates rising from 46% in the control group to 85% in the intervention group over a mean follow-up of 1.6 years.

Patients using the mHeart strategy also reported better understanding and knowledge of their medication regimens, indicating that the app not only enhanced adherence but also positively influenced patients' experiences with their treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile Health to Improve Adherence and Patient Experience in Heart Transplantation Recipients: The mHeart Trial. Gomis-Pastor, M., Mirabet Perez, S., Roig Minguell, E., et al.[2021]

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]

The pilot study involving 10 adolescent heart transplant recipients showed that an asynchronous Directly Observed Therapy (DOT) mHealth application was highly acceptable and feasible, with 90.1% of medication adherence videos submitted by patients.

Although the study indicated a 21.7% decrease in medication non-adherence after 12 weeks, the results were not statistically significant due to the small sample size, suggesting that further research is needed to confirm the effectiveness of this intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Directly observed therapy to promote medication adherence in adolescent heart transplant recipients. Killian, MO., Clifford, S., Lustria, MLA., et al.[2022]

Young adult heart transplant recipients transitioning to adult care show similar baseline characteristics in terms of medication adherence and knowledge about their condition, indicating a need for improved education and support during this transition.

Both intervention and usual care groups demonstrated a lack of essential knowledge about heart transplant management and self-advocacy skills, highlighting the importance of targeted interventions to enhance these areas for better health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pediatric Heart Transplantation: Transitioning to Adult Care (TRANSIT): Baseline Findings. Grady, KL., Hof, KV., Andrei, AC., et al.[2019]

The study analyzed 894 messages exchanged between 10 adolescent heart transplant patients and nursing staff over a 12-week mobile video therapy intervention, highlighting the importance of communication in promoting medication adherence.

Findings revealed that effective two-way communication, categorized into support, medical inquiries, and functional information, significantly contributed to patient engagement and improved adherence to immunosuppressive medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Engaging Adolescent Heart Transplant Recipients Through In-App Messaging During Mobile Health Intervention. Killian, MO., Schelbe, L., Lustria, MLA., et al.[2023]

A pilot study was conducted to explore the use of mobile video directly observed therapy (mDOT) to improve medication adherence in pediatric organ transplant patients, addressing the challenges posed by the COVID-19 pandemic.

This innovative approach leverages mobile health technology to potentially enhance patient outcomes by ensuring that children take their medications as prescribed, which is crucial for the success of organ transplants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Directly observed therapy to promote medication adherence in paediatric heart transplant recipients. Killian, MO., Clifford, SA., Gupta, D.[2021]

In a proof-of-concept study involving 5 out of 8 eligible youth living with HIV, video directly observed therapy (VDOT) showed promise in improving medication adherence, with all participants achieving virologic suppression one month after starting the intervention.

Participants reported high satisfaction with VDOT, suggesting it could be an effective method for enhancing adherence to antiretroviral therapy, although healthcare providers noted it could be burdensome at times, indicating a need for larger studies to further evaluate its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Video directly observed therapy to improve adherence of human immunodeficiency virus infected adolescents to combination antiretroviral therapy: a proof-of-concept study. Kordy, F., Nashid, N., Khan, S., et al.[2023]

Digital directly observed therapy (DOT) is found to be acceptable and feasible, showing higher rates of treatment completion and adherence compared to traditional in-person monitoring, based on a review of 28 studies.

Despite its effectiveness in improving medication adherence, digital DOT has not yet been utilized for monitoring antiretroviral therapy (ART) adherence in HIV treatment, indicating a gap in its application for this specific population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital directly observed therapy to monitor adherence to medications: a scoping review. Stoner, MCD., Maragh-Bass, AC., Sukhija-Cohen, AC., et al.[2023]

The pilot study involving 29 women with metastatic breast cancer demonstrated that the CONnected CUstomized Treatment Platform effectively maintained a high palbociclib adherence rate of 95.8%, indicating its potential for improving medication compliance.

Despite the high adherence rate, participants reported no significant changes in symptom burden or quality of life over three months, suggesting that while the intervention is feasible, further improvements in usability are needed to enhance overall patient experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving palbociclib adherence among women with metastatic breast cancer using a CONnected CUstomized Treatment Platform: A pilot study. Sadigh, G., Meisel, JL., Byers, K., et al.[2023]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Mobile Health to Improve Adherence and Patient Experience in Heart Transplantation Recipients: The mHeart Trial. [2021]

2. Canada pubmed.ncbi.nlm.nih.gov

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

3. Denmark pubmed.ncbi.nlm.nih.gov

Directly observed therapy to promote medication adherence in adolescent heart transplant recipients. [2022]

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

Pediatric Heart Transplantation: Transitioning to Adult Care (TRANSIT): Baseline Findings. [2019]

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

Engaging Adolescent Heart Transplant Recipients Through In-App Messaging During Mobile Health Intervention. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Directly observed therapy to promote medication adherence in paediatric heart transplant recipients. [2021]

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

Video directly observed therapy to improve adherence of human immunodeficiency virus infected adolescents to combination antiretroviral therapy: a proof-of-concept study. [2023]

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

Digital directly observed therapy to monitor adherence to medications: a scoping review. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Improving palbociclib adherence among women with metastatic breast cancer using a CONnected CUstomized Treatment Platform: A pilot study. [2023]