50 Participants Needed

Medication Adherence App for Bone Marrow Transplant Care

(Bmt4me 2 Trial)

MA
Overseen ByMicah A Skeens, PhD, APRN, CPNP
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: Micah Skeens
Must be taking: Immunosuppressants, Anti-infectives
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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 data supports the effectiveness of the BMT4me 2.0 app treatment for improving medication adherence in bone marrow transplant care?

Research shows that digital health tools like the BMT4me app can help improve medication adherence by sending reminders and tracking medication use, which is crucial for children undergoing bone marrow transplants. Similar apps have shown promise in enhancing symptom monitoring and improving outcomes in patients with complex conditions.12345

Is the BMT4me app safe for use in humans?

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 reported. It acts as a virtual assistant to remind caregivers about medication schedules and track symptoms, aiming to improve health outcomes.13467

How is the BMT4me 2.0 app treatment different from other treatments for bone marrow transplant care?

The BMT4me 2.0 app is unique because it acts as a 'virtual assistant' to help caregivers manage medication schedules for children who have undergone bone marrow transplants, providing real-time tracking and reminders, which is not typically offered by standard care or other digital health interventions.12345

What is the purpose of this trial?

This is a mixed methods, prospective longitudinal pilot RCT to evaluate the 1) acceptability of a newly developed mHealth app (BMT4me), 2) the feasibility of enrolling and retaining caregivers of children in the acute phase post-HSCT, and 3) the potential efficacy of an mHealth app on adherence to immunosuppressants in post-HSCT children discharged during the acute phase.

Eligibility Criteria

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.
See 2 more

Exclusion Criteria

I am unable to give consent for myself.

Timeline

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: BMT4me 2.0 Intervention GroupExperimental Treatment1 Intervention
The intervention group will be receiving the BMT4me 2.0 app at discharge as the primary intervention.
Group II: BMT4me 2.0 Control GroupActive Control1 Intervention
The control group will be receiving usual care at discharge. These participants will not be receiving the BMT4me 2.0 app.

Find a Clinic Near You

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+

Findings from Research

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

References

Improving medication adherence monitoring and clinical outcomes through mHealth: A randomized controlled trial protocol in pediatric stem cell transplant. [2023]
Theory-driven development of a medication adherence intervention delivered by eHealth and transplant team in allogeneic stem cell transplantation: the SMILe implementation science project. [2021]
Assessing the Feasibility of a Novel mHealth App in Hematopoietic Stem Cell Transplant Patients. [2023]
Feasibility of a New Model of Care for Allogeneic Stem Cell Transplantation Recipients Facilitated by eHealth: The MY-Medula Pilot Study. [2023]
Investigating the use of Barrows Cards to improve self-management and reduce healthcare costs in adolescents with blood cancer: a pilot study. [2016]
Impact of a health information technology tool addressing information needs of caregivers of adult and pediatric hematopoietic stem cell transplantation patients. [2020]
Directly observed therapy to promote medication adherence in adolescent heart transplant recipients. [2022]
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