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Improving Medication Adherence and Clinical Outcomes After Hematopoietic Stem Cell Transplant

Improving Medication Adherence and Clinical Outcomes After Hematopoietic Stem Cell Transplant 1024 683 JoAnna Pendergrass, DVM

A clinical trial is evaluating the acceptability and efficacy of a mobile app in improving medication adherence, symptoms and clinical outcomes in pediatric hematopoietic stem cell patients.

A research team led by Micah Skeens, PhD, APRN, FAAN, principal investigator in the Center for Biobehavioral Health at the Abigail Wexner Research Institute, assistant professor of pediatrics in The Ohio State University College of Medicine and nurse practitioner with the Division of Hematology, Oncology and Blood and Marrow Transplant at Nationwide Children’s Hospital, is conducting a pilot clinical trial using a mobile health app they created — BMT4me© — to monitor medication adherence, symptoms and clinical outcomes of pediatric hematopoietic stem cell transplant (HCT) patients. The National Institutes of Health-funded trial protocol was recently published in PLoS ONE.

Medication nonadherence contributes to adverse clinical outcomes and costs the health care industry nearly $100 billion annually. Nonadherence rates are above 50% for pediatric chronic illness patients and adult HCT patients, but little is known about medication nonadherence for pediatric HCT patients.

“It is assumed that pediatric HCT patients will take their medicine because not doing so could be fatal,” says Dr. Skeens. “However, a myriad of post-transplant complexities and challenges faced by the patients’ caregivers present a significant barrier to medication adherence.”

The clinical trial will enroll 50 caregivers of children in the acute phase post-HCT (first 100 days), randomized 1:1 into a standard of care or intervention group.

All caregivers will receive an electronic adherence monitoring device, either a MedyRPM box or MEMS® Cap. Those in the intervention group will have the BMT4me© app downloaded onto their mobile devices and receive instructions on its use. They will log medication doses and information such as symptoms and symptom severity.

Before the clinical trial, the researchers worked extensively with patients, caregivers and providers on the app’s user-centered design.

“Working with the families and key stakeholders in the app’s development was central to us being able to move forward with the clinical trial,” explains Dr. Skeens.

Multiple assessments will be collected until approximately 100 days post-transplant or medication taper completion, including weekly in-person or virtual check-ins and the Pediatric Quality of Life Inventory every three weeks.

Other data to be collected will include weekly Graft vs. Host Disease (GVHD) scores, readmission rates and monthly medication adherence.

A simultaneous multisite clinical trial funded by the National Institute of Minority and Health Disparities with Columbia University will enroll Spanish-speaking pediatric HCT patients and evaluate the app’s efficacy in improving post-transplant clinical outcomes in Hispanic children undergoing HCT.

“We believe the app monitors medication adherence and symptoms in real time, allowing us to create personalized interventions to help the caregivers improve post-transplant medication adherence and outcomes,” says Dr. Skeens.

This article also appears in the Spring/Summer 2024 print issue. Download the full issue.

 

Reference:

Ralph JE, Sezgin E, Stanek CJ, Landier W, Pai ALH, Gerhardt CA, Skeens MA. Improving medication adherence monitoring and clinical outcomes through mHealth: A randomized controlled trial protocol in pediatric stem cell transplant. PLoS ONE. 2023;18(8):e0289987.

Image credit: Adobe Stock

About the author

JoAnna Pendergrass

JoAnna Pendergrass, DVM, is a veterinarian and freelance medical writer in Atlanta, GA. She received her veterinary degree from the Virginia-Maryland College of Veterinary Medicine and completed a 2-year postdoctoral research fellowship at Emory University’s Yerkes Primate Research Center before beginning her career as a medical writer.

As a freelance medical writer, Dr. Pendergrass focuses on pet owner education and health journalism. She is a member of the American Medical Writers Association and has served as secretary and president of AMWA’s Southeast chapter.

In her spare time, Dr. Pendergrass enjoys baking, running, and playing the viola in a local community orchestra.

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