Supporting Treatment Adherence Regimens in Pediatric Epilepsy: The STAR Trial
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Neurology, Epilepsy |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | 2 - 12 |
| Updated: | 1/13/2019 |
| Start Date: | April 2013 |
| End Date: | December 2020 |
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.
(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.
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.
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.
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.
We found this trial at
1
site
3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
Cincinnati, Ohio 45229
1-513-636-4200
Principal Investigator: Avani C Modi, Ph.D.
Phone: 513-803-2745
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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