Improving medication adherence monitoring and clinical outcomes through mHealth: A randomized controlled trial protocol in pediatric stem cell transplant

Abstract

Medication non-adherence rates in children range between 50% and 80% in the United States. Due to multifaceted outpatient routines, children receiving hematopoietic stem cell transplant (HCT) are at especially high risk of non-adherence, which can be life-threatening. Although digital health interventions have been effective in improving non-adherence in many pediatric conditions, limited research has examined their benefits among families of children receiving HCT. To address this gap, we created the BMT4me© mobile health app, an innovative intervention serving as a “virtual assistant” to send medication-taking reminders for caregivers and to track, in real-time, the child’s medication taking, barriers to missed doses, symptoms or side effects, and other notes regarding their child’s treatment. In this randomized controlled trial, caregivers will be randomized to either the control (standard of care) group or the intervention (BMT4me© app) group at initial discharge post-HCT. Both groups will receive an electronic adherence monitoring device (i.e., medication event monitoring system “MEMS” cap, Medy Remote Patient Management “MedyRPM” medication adherence box) to store their child’s immunosuppressant medication. Caregivers who agree to participate will be asked to complete enrollment, weekly, and monthly parent-proxy measures of their child’s medication adherence until the child reaches Day 100 or complete taper from immunosuppression. Caregivers will also participate in a 15 to 30-minute exit interview at the conclusion of the study. Descriptive statistics and correlations will be used to assess phone activity and use behavior over time. Independent samples t-tests will examine the efficacy of the intervention to improve adherence monitoring and reduce readmission rates. The primary expected outcome of this study is that the BMT4me© app will improve the real-time monitoring and medication adherence in children receiving hematopoietic stem cell transplant following discharge, thus improving clinical outcomes.

Modern technologies for improving elderly patients’ compliance

“…Numerous smartphone apps available for the main operating systems support medication self-management [61] and therapy regimen adherence [82]. The level of complexity of such software varies widely, from simple medication lists and reminders to advanced interactive virtual assistants that not only send medication reminders to patients and their caregivers but also track patients as they take medication or miss doses, while also allowing notes to be taken on reported symptoms, side effects and other treatment topics [83]. Such approaches have been tested in the treatment of numerous conditions, mainly chronic, including diabetes [84], arterial hypertension [85], cardiovascular disease [86], heart failure [87], ankylosing spondylitis [88], postoperative pain [89], cancer [90] pain, food allergies and intolerances [91] and sleep disturbances [92].…”

Is there an app for that? A Systematic Search and Analysis of mHealth apps in the digital marketplace for pediatric cancer patients (Preprint)

“…One of the early investigations highlighted cancer apps for adolescent and young adult cancer patients with their functionalities for symptom tracking, pain management, monitoring, and medication management [13]. In recent literature, studies focus on electronic medical diaries for mood, symptom and treatment tracking [14], care after cancer treatment [15], pre-rehabilitation support [16], and post-treatment medical adherence [17]. In addition, newer mHealth technologies have leveraged wearable technologies for tracking physical activity [18,19], social media behaviors [19,20], web-text messaging for weight management [21], and gamification of monitoring symptoms to address cancer-associated pain through self-guidance [22,23].…”