Accepted for/Published in: JMIR Research Protocols
Date Submitted: Apr 28, 2022
Date Accepted: May 13, 2022
A Mobile Health Application to Promote Adherence to Immunosuppressant Medication and Track Symptoms in Children After Hematopoietic Stem Cell Transplant: A Protocol for a Mixed Methods Usability Study
ABSTRACT
Background:
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. In pediatrics, adherence is largely dependent on caregivers. In a high-risk Hematopoietic Stem Cell Transplant (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. The most successful adherence interventions, and thus improved clinical outcomes, have included mobile health (mHealth) reminder approaches and a direct measure of adherence.
Objective:
This is a three phase project, with this study protocol describing Phase 2, to determine the usability and feasibility of an mHealth application (app) (BMT4me) designed to promote adherence to immunosuppressant medication and to track symptoms among children who received HSCT.
Methods:
This study uses an iterative, convergent mixed methods design to develop and assess usability and feasibility of an adherence digital health intervention. We will recruit 15 caregivers of pediatric HSCT patients to complete user testing. Qualitative and quantitative data will be integrated to enhance and expand upon study findings.
Results:
We are currently enrolling families and anticipate completion of the study in 4 months.
Conclusions:
This protocol describes a mixed methods usability and feasibility study to develop and implement a smartphone application for caregivers of children receiving HSCT. The app was designed to improve immunosuppressant adherence and to track symptoms in the acute phase post-discharge. Study findings will inform further refinement of the app and the feasibility of a pilot randomized controlled trial examining efficacy on clinical outcomes. Clinical Trial: ClinicalTrials.gov NCT04976933; https://clinicaltrials.gov/ct2/show/NCT04976933
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