Supporting Treatment Adherence Regimens in Pediatric Epilepsy: The STAR Trial

Fifty-eight percent of children with new-onset epilepsy do not take their antiepileptic drugs (AEDs) as prescribed (i.e., non-adherence). Non-adherence, which is modifiable, is associated with continued seizures, mortality, poor quality of life, and high healthcare costs. There are no adherence interventions for young children with epilepsy and their families; thus, the current proposal examines a family-based behavioral treatment focused on improving epilepsy knowledge and problem-solving around barriers to adherence in young children with epilepsy and their families with the goal of improving adherence and ultimately, seizures and quality of life. It is hypothesized that children with newly diagnosed epilepsy and their families who participate in the problem-solving intervention will have significant improvements on adherence compared to those in the education only intervention.

Study Overview

• Status: Completed
• Conditions: Epilepsy
• Intervention / Treatment: Behavioral: Education Only; Behavioral: STAR

Detailed Description

Non-adherence to antiepileptic drugs (AEDs) is a common (i.e., 58% of patients have some level of non-adherence) and previously under-recognized problem for young children with newly diagnosed epilepsy. This is surprising given the consequences of non-adherence in patients with epilepsy are extremely serious, including continued seizures, mortality, and high healthcare expenditures. Despite the critical need to develop and implement interventions to improve adherence, there are no family-based interventions for young children with epilepsy and their families. As such, we developed a family-tailored adherence intervention (STAR: Supporting Treatment Adherence Regimens) focused on increasing epilepsy knowledge and problem-solving skills around barriers to adherence for children with epilepsy and their families. Data from our pilot adherence intervention studies demonstrated good preliminary effects (effect size= 0.64) and excellent feasibility, with families reporting that the intervention was beneficial and a positive experience for their family. Capitalizing on these findings, the next logical step is to test the efficacy of the STAR intervention to improve AED adherence in 200 children with epilepsy via a randomized controlled trial. Thus, the aims of the study are to examine the short-term and long-term effects of the STAR intervention on electronically-monitored medication adherence in children with new-onset epilepsy compared to an education only (EO) intervention. In addition, exploratory aims are to examine the effect of the STAR intervention on seizure freedom and QOL in children with epilepsy compared to the EO intervention. The current study uses an innovative, sequential, randomization enrichment design that preventatively targets 200 patients with new-onset epilepsy, between 2-12 years, who demonstrate non-adherence. Using criteria established from our pilot studies, adherence falling below 95% within the first six months of the study will trigger participant randomization into one of two 8-session interventions: STAR or EO. If the aims of the project are achieved, this study will change the practice of pediatric epilepsy by providing a proven approach to the routine monitoring and treatment of AED non-adherence in epilepsy clinics across the nation. This study also lays the foundation for determining the long term impact of adherence intervention on morbidity and mortality. In addition, this study's innovative methodological enrichment design should be generalizable to other pediatric conditions and lead to the development of cost effective, clinic-based adherence promotion interventions.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• ages 2-12 years
• diagnosis of epilepsy within approximately 6 months
• only one prescribed AED
• family lives < 75 miles from Cincinnati Children's Hospital Medical Center (CCHMC)
• ability to read English

Exclusion Criteria:

• comorbid medical disorders requiring daily medication
• parent-reported significant developmental delays (e.g. Autism)
• liquid AED formulation due to electronic monitoring incompatibility.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Education Only; Education only arm (8 total sessions)	Behavioral: Education Only; Education around epilepsy (8 total sessions)
Experimental: STAR: Education and Problem Solving; Problem-solving and education intervention (8 total sessions)	Behavioral: STAR; Problem-solving and education intervention (8 total sessions)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence rate (short-term)	This is a measure of adherence, using an electronic monitor called the Medication Event Monitoring System (MEMS) TrackCap, and adherence rates range from 0 to 100%. Adherence rates will be calculated at baseline and represent a rate from 0 to 100. Similarly, an adherence rate will be calculated for the 30 day post intervention period, with a rate between 0-100%. The change score for the mean of the 30 days of adherence immediately following the end of intervention relative to the mean adherence obtained during the30 day screening period will be calculated.	30 day post intervention adherence rate

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence rate (long-term)	This is a measure of adherence, using an electronic monitor called the MEMS TrackCap, and adherence rates range from 0 to 100%. The outcome will be a comparison of baseline 30 day adherence, which ranges from 0 to 100%, to the 3, 6, and 12 month post intervention adherence to antiepileptic drugs (0-100%). A change score will be calculated between the baseline and long-term end points of 3, 6 and 12 months.	3, 6 and 12 months post intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health related quality of life	Compare baseline quality of life scores (0-100), based on the PedsQL (Pediatric Quality of Life) questionnaire, compared to 6 and 12 months post intervention.	6 and 12 months post intervention
Seizure absence/presence	Compare seizure absence/presence (0=no;1=yes) from baseline to 6 and 12 months post intervention	6 and 12 months post intervention

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Avani C Modi, Ph.D., Children's Hospital Medical Center, Cincinnati

Publications and helpful links

General Publications

• Al-Aqeel S, Gershuni O, Al-Sabhan J, Hiligsmann M. Strategies for improving adherence to antiepileptic drug treatment in people with epilepsy. Cochrane Database Syst Rev. 2020 Oct 22;10(10):CD008312. doi: 10.1002/14651858.CD008312.pub4.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2013
• Primary Completion (Actual): December 1, 2019
• Study Completion (Actual): December 1, 2019

Study Registration Dates

• First Submitted: May 1, 2013
• First Submitted That Met QC Criteria: May 8, 2013
• First Posted (Estimate): May 10, 2013

Study Record Updates

• Last Update Posted (Actual): January 23, 2020
• Last Update Submitted That Met QC Criteria: January 22, 2020
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Epilepsy
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy
• Other Study ID Numbers: R01HD073115 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Not being shared