Medication Adherence App for Bone Marrow Transplant Care

(Bmt4me 2 Trial)

Overseen By Micah A Skeens, PhD, APRN, CPNP

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Micah Skeens

Must be taking: Immunosuppressants, Anti-infectives

Disqualifiers: Adults unable to consent

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

Compensation: Varies

Number of Visits: Unknown

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a mobile app called BMT4me 2.0 to determine its effectiveness in helping caregivers of children adhere to medication schedules after a bone marrow transplant. Researchers aim to assess whether caregivers find the app useful and if it improves medication adherence, particularly for children who recently underwent a transplant and are on immunosuppressants. Participants will either use the app or continue with usual care. The trial seeks caregivers who live with children discharged after a transplant and have a smartphone. As an unphased trial, it offers caregivers the chance to contribute to innovative research that could enhance post-transplant care.

Will I have to stop taking my current medications?

The trial does not specify whether participants must stop taking their current medications. It focuses on using an app to help with medication adherence for children post-transplant.

What prior data suggests that the BMT4me 2.0 app is safe for use in post-HSCT care?

Research has shown that the BMT4me 2.0 app has been used in studies with children undergoing bone marrow transplants, and no safety problems have emerged. The app helps ensure that patients take their medications as prescribed. Designed for ease of use, it has been tested for its effectiveness in helping kids follow their treatment plans.

Although the app is new, the absence of reported safety issues in earlier studies is a positive sign. This indicates that users have not experienced negative effects. For those considering joining a trial with the BMT4me 2.0 app, it is reassuring to know that others in similar situations have used it without problems. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the BMT4me 2.0 app because it brings a fresh approach to improving medication adherence for bone marrow transplant patients. Unlike traditional methods that rely on patient memory or manual tracking, this app offers a digital solution to ensure patients take their medication as prescribed. The app is designed to streamline the post-transplant care process, potentially leading to better health outcomes by reducing the risk of complications due to missed doses. By integrating modern technology into patient care, the BMT4me 2.0 app represents a significant advancement over standard practices, which often lack this level of personalized support and engagement.

What evidence suggests that the BMT4me 2.0 app is effective for improving medication adherence in post-HSCT children?

Research shows that the BMT4me app holds promise in helping children take their medications on time after a bone marrow transplant. In this trial, participants in the BMT4me 2.0 Intervention Group will receive the app at discharge as the primary intervention. Studies have found that similar health apps have successfully helped kids with other conditions, like childhood obesity and infant HIV, stick to their medication schedules. The BMT4me app provides real-time, personalized support for managing medications, which is crucial for kids after a transplant. Early results suggest that using this app could improve medication adherence without any safety concerns. ^{3 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for primary caregivers who speak English and have an iOS or Android device. Their children must be aged 2-12, receiving immunosuppression post-allogeneic bone marrow transplant, and discharged before Day 100 of immunosuppression tapering. Adults unable to consent and pregnant women cannot participate.

Inclusion Criteria

Children must be residing with the primary caregiver that enrolls on the study

My children are between 0 and 21 years old.

My child is on immunosuppressants for a transplant from a donor.

Exclusion Criteria

I am unable to give consent for myself.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Acute Phase Post-HSCT

Participants are monitored for medication adherence and receive the BMT4me 2.0 app or usual care at discharge

14 weeks

Weekly visits for monitoring

Follow-up

Participants are monitored for safety and effectiveness after the acute phase

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BMT4me 2.0 app

Trial Overview

The BMT4me study tests a mobile health app designed to help caregivers manage their child's medication after a bone marrow transplant. It looks at how well the app is received, its ability to keep participants engaged over time, and if it improves adherence to taking prescribed immunosuppressants.

How Is the Trial Designed?

Group I: BMT4me 2.0 Intervention Group Experimental Treatment 1 Intervention

The intervention group will be receiving the BMT4me 2.0 app at discharge as the primary intervention.

Group II: BMT4me 2.0 Control Group Active Control 1 Intervention

The control group will be receiving usual care at discharge. These participants will not be receiving the BMT4me 2.0 app.

Who Is Running the Clinical Trial?

Micah Skeens

Lead Sponsor

Trials

2

Recruited

70+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Published Research Related to This Trial

The MY-Medula mHealth platform was successfully implemented in a pilot study with 28 allogeneic stem cell transplantation (allo-SCT) recipients, showing high usability with a median of 143 app visits per patient over 2 months.

Patients and healthcare professionals reported high satisfaction rates (95% and 100%, respectively) with the integrated care model, indicating that mHealth tools can enhance follow-up care for allo-SCT recipients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a New Model of Care for Allogeneic Stem Cell Transplantation Recipients Facilitated by eHealth: The MY-Medula Pilot Study. Redondo, S., De Dios, A., Gomis-Pastor, M., et al.[2023]

Medication non-adherence in children, especially those receiving hematopoietic stem cell transplants, is a significant issue, with rates between 50% and 80%, which can lead to life-threatening complications.

The BMT4me© mobile health app is designed to improve medication adherence by sending reminders and tracking medication-taking behaviors in real-time, and its efficacy will be evaluated in a randomized controlled trial comparing it to standard care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving medication adherence monitoring and clinical outcomes through mHealth: A randomized controlled trial protocol in pediatric stem cell transplant. Ralph, JE., Sezgin, E., Stanek, CJ., et al.[2023]

A new intervention module was developed to improve medication adherence for patients undergoing allogeneic stem cell transplantation, focusing on the implementation and persistence phases of adherence using a structured approach based on behavior change theories.

The intervention identified key behaviors and barriers related to immunosuppressant use, and selected specific strategies like education and goal setting to enhance adherence, which could serve as a model for future eHealth solutions in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Theory-driven development of a medication adherence intervention delivered by eHealth and transplant team in allogeneic stem cell transplantation: the SMILe implementation science project. Ribaut, J., Leppla, L., Teynor, A., et al.[2021]

The BMT Roadmap application was found to be useful for caregivers of HSCT patients, leading to increased caregiver activation and decreased feelings of burden during hospitalization.

Despite the positive effects on activation and burden, caregivers reported a decrease in overall quality of life at discharge, highlighting the need for ongoing support and resources for caregivers throughout the HSCT process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a health information technology tool addressing information needs of caregivers of adult and pediatric hematopoietic stem cell transplantation patients. Fauer, AJ., Hoodin, F., Lalonde, L., 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]

The Barrows Cards method significantly improved adherence to immunosuppressive therapy among 17 adolescents with blood cancer following hematopoietic stem-cell transplantation, indicating its potential as an effective educational tool.

This method not only enhanced self-management skills but also contributed to reduced hospital readmissions and healthcare costs, suggesting it could be a cost-effective intervention for chronic illness management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Investigating the use of Barrows Cards to improve self-management and reduce healthcare costs in adolescents with blood cancer: a pilot study. Bagnasco, A., Calza, S., Petralia, P., et al.[2016]

The TRU-BMT mHealth app was developed to help hematopoietic stem cell transplantation (HCT) patients monitor their health daily, aiming to improve symptom tracking and early detection of complications, with a pilot study involving 30 patients over 180 days.

Adherence to the app was around 30% daily and 44% weekly, and higher adherence correlated with better health outcomes, such as increased meal completion and shorter hospital stays, indicating the app's potential to enhance patient management during HCT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing the Feasibility of a Novel mHealth App in Hematopoietic Stem Cell Transplant Patients. Racioppi, A., Dalton, T., Ramalingam, S., et al.[2023]

Citations

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The BMT4me app demonstrated promising usability as a mHealth intervention among pediatric patients undergoing HCT.

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BMT4me: Post-HSCT Medication Adherence mHealth App

Within pediatrics, BE has been successful in reducing childhood obesity, increasing vaccination rates, and improving adherence rates to infant HIV medications.

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Supporting Medication Adherence in Pediatric Patients ...

This study aimed to assess the usability of a mHealth intervention (BMT4me) designed to serve as a real-time, personalized tool for medication management or ...

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withpower.com/trial/phase-hematopoietic-stem-cell-transplantation-sct-8-2022-55955

Medication Adherence App for Bone Marrow Transplant Care

The BMT4me app has been used in studies to help monitor medication adherence in children undergoing bone marrow transplants, and no safety issues have been ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10434937/

Improving medication adherence monitoring and clinical ...

The BMT4me app will improve the real-time monitoring and medication adherence in children receiving hematopoietic stem cell transplant following discharge.

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clinicaltrial.be

clinicaltrial.be/nl/details/23895?per_page=100&recruiting=1&enrolling_by_invitation=0&active_not_recruiting=0&not_yet_recruiting=0&completed=0&only_recruiting=1&only_eligible=0

BMT4me: Post-HSCT Medication Adherence mHealth App

poor adherence is generally associated with adverse outcomes, including complications, hospital admissions, and even death. The societal burden of cancer care ...

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researchprotocols.org

researchprotocols.org/2022/7/e39098/

An mHealth App to Promote Adherence ...

This protocol describes a mixed methods usability and feasibility study to develop and implement a smartphone app for caregivers of children receiving HSCT.

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Transcreating BMT4me: A protocol for adapting an mobile ...

Hematopoietic stem cell transplant is a life-saving procedure that treats patients with various conditions by transplanting hematopoietic ...