BMT4me: Post-HSCT Medication Adherence mHealth App (Bmt4me 2)

Micah Skeens

Status: Enrolling

Conditions: Adherence, Medication; Digital Health; Stem Cell Transplant

Treatments: Device: BMT4me 2.0 app

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05515497

STUDY00002478

4R00NR019115-03 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

In the United States, poor adherence accounts for up to 70% of all medication-related hospital admissions, resulting in $100 billion in healthcare costs annually Adherence rates have been reported as low as 0% in pediatric patients. Reasons for non-adherence are multifactorial. The most important determinants of non-adherence are consistently documented as complexity and duration of treatment regimens, as well as forgetfulness. Thus, children undergoing difficult hematopoietic stem cell transplants (HSCT) that require medication indefinitely are at high risk for medication non-adherence.

Only 4 published studies exist regarding adherence in pediatric HSCT. None address adherence to immunosuppressant medication, nor are they RCTs. Second, the complexity of most interventions for adherence is counter to the geographic, resource, and time constraints families of chronically ill children face. Adherence interventions based on conventional behavior theory have been cumbersome for families already stressed due to chronic illness. BE design is a significant paradigm shift to a simpler, less onerous approach that can engage those patients and families that would otherwise forego complicated adherence interventions. Although mHealth adherence apps are a widely available, simple, and innovative approach to addressing these problems, a third gap relates to poor usability. For example, a recent review of pediatric adherence apps found that none identified individual barriers to adherence, and nearly all were designed for adults. Thus, there is an urgent need to develop and evaluate innovative, accessible, and evidence-based approached to adherence among children receiving HSCT to prevent morbidity and mortality from GVHD.

The impact of non-adherence on clinical outcomes is largely unknown in pediatric HSCT. poor adherence is generally associated with adverse outcomes, including complications, hospital admissions, and even death. The societal burden of cancer care and HSCT is substantial and likely to increase based on the growing number of transplants each year. Clinicians and researchers have focused on GVHD prevention to minimize unnecessary treatment-related deaths. Acute GVHD develops in the first 100 days post-transplant. Children that develop acute GVHD have a 30% to 50% chance of survival. Morbidity and mortality due to GVHD can be decreased through prophylactic use of immunosuppressants. Although these medications are costly and produce unpleasant side effects, adherence is critical to decrease complications, reduce readmissions, and ultimately increase quality of life and survival.

Adherence is complex, but ultimately, the final common pathway to adherence is human behavior. In pediatrics, adherence is largely dependent on parents. As the primary caregivers, they are responsible for ensuring children receive the prescribed therapy correctly. In a high-risk HSCT population, caregivers are isolated with their child due to infection risk and must manage challenging treatment regimens at home, often with limited time and support. Complex behavioral interventions, typically employed to address adherence, are difficult to deliver and manage in the context of these daily tasks. Alternatively, behavioral economics (BE) theory suggests that small "nudges" can produce and sustain behavior change. A BE approach is a significant paradigm shift and assumes decision-making can be influenced through low-intensity interventions to lead patients to optimal choices. Improved adherence to medication and exercise programs using BE designed interventions in adults have been positive. Within pediatrics, BE has been successful in reducing childhood obesity, increasing vaccination rates, and improving adherence rates to infant HIV medications.

Enrollment: 50 estimated patients

Sex: All

Ages: Under 21 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Children of caregivers must be a) 0 to 21 years of age; b) receiving immunosuppression for an allogeneic transplant or anti-infective for an autologous transplant; c) discharged prior to Day 100 or completion of immunosuppression taper, and d) residing with the primary caregiver that enrolls on the study.
• Primary caregivers must be: d) English-speaking; and e) have an iOS or Android capable cellular device.

Exclusion criteria

• Adults unable to consent

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

50 participants in 2 patient groups

BMT4me 2.0 Intervention Group

Experimental group

Description:

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

Treatment:

Device: BMT4me 2.0 app

BMT4me 2.0 Control Group

No Intervention group

Description:

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