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Randomized Controlled Trial
. 2025 Aug;29(5):e70109.
doi: 10.1111/petr.70109.

Development of a Targeted, Telehealth Intervention: Experiences From the Improving Medication Adherence in Adolescents and Young Adults Following a Liver Transplantation (iMALT) Multisite Trial

Rebecca Tutino  1 , Rachel Annunziato  1   2 , Claire Dunphy  2 , Ravinder Anand  3 , Jeff Mitchell  3 , Margaret Stuber  4 , Eyal Shemesh  2 , Sarah Duncan-Park  2 ; for iMALT
Affiliations
Randomized Controlled Trial

Development of a Targeted, Telehealth Intervention: Experiences From the Improving Medication Adherence in Adolescents and Young Adults Following a Liver Transplantation (iMALT) Multisite Trial

Rebecca Tutino et al. Pediatr Transplant. 2025 Aug.

Abstract

Background: Medication non-adherence is a major reason for poor outcomes across chronic diseases. Specifically, it is the most common cause for organ rejection in pediatric liver transplant recipients. Therefore, understanding how to improve adherence through behavior change interventions could lead to substantial health benefits. The Improving Medication Adherence in Adolescents who had a Liver Transplant (iMALT) study is a longitudinal, multisite, randomized controlled trial that uses a biomarker of adherence (the Medication Level Variability Index, calculated from electronic health record information) to identify non-adherent patients. The fully remote intervention uses repeat measurements of the biomarker to determine intervention intensity over time. This paper describes the iMALT intervention with an emphasis on innovative elements, including the use of a biomarker to guide the intervention as it unfolds, the theoretical framework, and delivery methods.

Methods: We use the Template for Intervention Description and Replication (TIDieR) guidelines to describe the iMALT intervention. We review design elements that help to improve engagement (in a particularly hard-to-engage cohort) and reduce attrition, discuss the tailoring paradigm that uses biomarker readings to modify aspects of the manual-driven protocol, and present considerations for designing remote interventions that engage patients across state lines.

Conclusions: Our intervention introduces a novel concept in behavioral intervention design-the use of a biomarker to identify risk and inform intervention intensity while the intervention is ongoing. The remote approach, which allows for intervention dissemination from one "hub" of trained individuals and decreased patient burden, may also inform future intervention designs.

Keywords: intervention development; liver transplant; medication adherence; pediatric; randomized controlled trial; telehealth.

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References

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