Fostering Medication Adherence in Children With Epilepsy Using mHealth Technology

Epilepsy Adherence in Children and Technology (eACT)

Sponsors

Lead sponsor: Children's Hospital Medical Center, Cincinnati

Collaborator: National Institute of Nursing Research (NINR)
Medical University of South Carolina
Children’s Hospital of Orange County
University of Cincinnati
Nationwide Children's Hospital
North Carolina State University

Source Children's Hospital Medical Center, Cincinnati
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.

Overall Status Recruiting
Start Date April 15, 2019
Completion Date September 2023
Primary Completion Date September 2022
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Adherence rates Month 8
Adherence rates Month 14
Adherence rates Month 20
Secondary Outcome
Measure Time Frame
Change in seizure frequency Months 8-14
PedsQL Epilepsy Module (health-related quality of life measure) Month 14
Healthcare utilization (the number of emergency room visits and hospitalizations) Months 8-20
Enrollment 600
Condition
Intervention

Intervention type: Behavioral

Intervention name: Education microlearning sessions

Description: mHealth education microlearning sessions

Intervention type: Behavioral

Intervention name: Automated digital reminders

Description: reminders from electronic monitors based on texts or lights/chimes

Intervention type: Behavioral

Intervention name: Problem-solving mHealth module

Description: mhealht problem solving module with 2 telehealth sessions with a therapist

Arm group label: Treatment Group

Intervention type: Behavioral

Intervention name: Individualized Adherence Feedback Report

Description: Individual Adherence Feedback reports sent to parents weekly

Arm group label: Treatment Group

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

Gender: All

Minimum age: 2 Years

Maximum age: 12 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Avani Modi, Ph.D. Principal Investigator Children's Hospital Medical Center, Cincinnati
Overall Contact

Last name: Avani Modi, Ph.D.

Phone: 513-636-4864

Email: [email protected]

Location
facility status contact
Childrens Hospital of Orange County | Orange, California, 92868, United States Not yet recruiting Heather Huszti, Ph.D. 714-509-8481 [email protected]
Cincinnati Children's Hospital Medical Center | Cincinnati, Ohio, 45229, United States Recruiting Avani Modi, Ph.D. 513-636-4864 [email protected] Avani C Modi, Ph.D. Principal Investigator
Nationwide Children's Hospital | Columbus, Ohio, 43205, United States Recruiting Anup Patel, MD 614-722-4625 [email protected]
Medical University of South Carolina | Charleston, South Carolina, 29425, United States Recruiting Janelle Wagner, Ph.D. 843-792-3307 [email protected]
Location Countries

United States

Verification Date

May 2019

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Control Group

Arm group type: Active Comparator

Description: mHealth education module and automated digital reminders

Arm group label: Treatment Group

Arm group type: Experimental

Description: mHealth education module, automated digital reminders, and individualized adherence feedback (stage 1 SMART). After three months of intervention, the treatment group will be evaluated for responsiveness (> 95%) based on the 30-day adherence outcome (stage 2 SMART). If participants in the treatment group demonstrate adherence > 95%, they will continue with the treatment arm of receiving automated digital reminders and individualized adherence feedback. If they are deemed to be non-responsive (adherence < 95%), they will be re-randomized to either: 1) continued automated digital reminders and individualized adherence feedback or 2) a mHealth problem solving module with three therapist-guided problem-solving sessions.

Acronym eACT
Patient Data Yes
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

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

Masking: Double (Care Provider, Investigator)

Masking description: The PI will not be notified of group status or details of participants. The healthcare provider will also not know which group participants are randomized to.

Source: ClinicalTrials.gov