Clinical trial NCT03817229: Epilepsy Adherence in Children and Technology (eACT)
Official title: Fostering Medication Adherence in Children With Epilepsy Using mHealth Technology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epilepsy
Keywords: adherence
mHealth
eHealth
children
caregivers
compliance
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
name: Medical University of South Carolina
name: Children's Hospital of Orange County
name: University of Cincinnati
name: Nationwide Children's Hospital
name: North Carolina State University
First posted: 2019-01-25
Enrollment: 466
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This a 2-stage, sequential, multiple assignment, randomized trial (SMART) . In Stage 1 (three months long), non-adherent caregivers (\< 95%) will be randomized to a mHealth education module and automated digital reminders (control) or the mHealth education module, automated digital reminders, and individualized adherence feedback based on real-time adherence monitoring (treatment) to address the primary barrier of forgetting. At the beginning of Stage 2 (two months long), caregivers randomized to treatment who do not achieve adherence \> 95% (response) by the end of Stage 1 will be re-randomized to either continued individualized adherence feedback or individualized adherence feedback augmented with three mHealth problem-solving modules (translated from the PIs existing RCTs) with a therapist.
Primary purpose: TREATMENT

Brief summary: Fifty-eight percent of children with new-onset epilepsy do not take their antiepileptic drugs (AEDs) as prescribed, which is associated with continued seizures, mortality, poor quality of life, and high healthcare costs. Evidence-based adherence interventions are lacking and critically needed, especially for children with epilepsy, who represent an underserved population in pediatrics. The current proposal is a mHealth sequential, multiple assignment, randomized trial (SMART) focused on providing education, automated digital reminders, and individualized adherence feedback, as well as teaching problem-solving skills, with the goal of improving adherence and quality of life and decreasing seizures and health care utilization.

Detailed description: Non-adherence to antiepileptic drugs (AEDs) is a common problem (i.e., 58% of patients have some level of non-adherence) for young children with newly diagnosed epilepsy, with potentially devastating consequences. AED non-adherence is associated with a 3-fold increased risk of seizures, poor quality of life, inaccurate clinical decision-making, and higher health care utilization and costs. One of the primary barriers to adherence is forgetting, which may be particularly amenable to mHealth (mobile technology in healthcare) interventions. Despite the critical need to develop and implement interventions to improve adherence, there are few family-based interventions for young children with epilepsy and their families. One existing intervention is highly promising; however, this intervention requires six in-person sessions, which can be impossible for families who lack routine access to tertiary specialty care due to time, financial, or transportation constraints. Thus, unmet medical and psychosocial needs of the underserved pediatric epilepsy population are perpetuated and compounded by limited access to this state of the art care. The overall goal is to test a mHealth adherence intervention that is easily accessible using a stepped up care model based on individual needs. This stepped up care model will conserve patient, family, and provider time, costs and resources. The aim of this multi-site R01 is to conduct a two-stage, sequential, multiple assignment, randomized trial (SMART) to evaluate the effectiveness of mHealth intervention strategies for improving AED adherence in caregivers of young children with epilepsy. A two-month baseline period will be followed by two stages. In Stage 1 (3-months long), non-adherent caregivers (\< 95%) will be randomized to a mHealth education module and automated digital reminders (control) or the mHealth education module, automated digital reminders, and individualized adherence feedback based on real-time adherence monitoring (treatment) to address the primary barrier of forgetting. At the beginning of Stage 2 (two months long), caregivers randomized to treatment who do not achieve adherence \> 95% (response) by the end of Stage 1 will be re-randomized to either continued individualized adherence feedback or individualized adherence feedback augmented with two mHealth problem-solving modules (translated from the PIs existing RCTs) with a therapist. Thus, there are three intervention strategies embedded in this SMART: #1 control, #2 treatment, and #3 problem-solving augmented treatment if nonresponsive at three months. The primary outcome is electronically-monitored adherence and secondary outcomes include seizure severity/frequency, quality of life, and healthcare utilization. If the aims of the project are achieved, this study would have a large impact on pediatric epilepsy, with the potential to change clinical practice for treating non-adherence. The SMART design would allow the investigators to identify patients who are most likely to respond to interventions and step up care with more time- and resource-intensive interventions (i.e., problem-solving with a therapist via the web), when necessary.

Eligibility criteria: Inclusion criteria:

1. Children ages 2-12 years
2. Epilepsy diagnosis \< 2 years
3. Ability to read/speak English

Exclusion criteria:

1. Major comorbid neurodevelopmental or medical disorders (e.g., Autism, diabetes)
2. Plan to wean AEDs for 18 months

Primary outcomes:
measure: Adherence rates
timeFrame: Month 8
measure: Adherence rates
timeFrame: Month 14
measure: Adherence rates
timeFrame: Month 20
Secondary outcomes:
measure: Change in seizure frequency
timeFrame: Months 8-14
measure: PedsQL Epilepsy Module (health-related quality of life measure)
timeFrame: Month 14
measure: Healthcare utilization (the number of emergency room visits and hospitalizations)
timeFrame: Months 8-20
Other outcomes:
Locations:
city: Orange
country: United States
facility: Childrens Hospital of Orange County
state: California
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Avani Modi, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: