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Supporting treatment adherence regimens in children with epilepsy: A randomized clinical trial
Avani C Modi1,2, Shanna M Guilfoyle1,2, Tracy A Glauser1,2
1Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.
Insights
The Supporting Treatment Adherence Regimens (STAR) intervention significantly improved medication adherence in children with new onset epilepsy over 12 months compared to education alone. This family-based approach is effective for routine epilepsy care.
Area of Science:
- Pediatric Neurology
- Behavioral Science
- Clinical Trial Methodology
Background:
- New onset epilepsy in children requires effective adherence strategies for optimal management.
- Medication adherence is crucial for seizure control and improving health-related quality of life (HRQOL).
- Existing interventions may not adequately address the unique needs of young children and their families.
Purpose of the Study:
- To evaluate the efficacy of the Supporting Treatment Adherence Regimens (STAR) intervention compared to an education-only (EO) control group.
- To determine if STAR improves medication adherence in children (2-12 years) with new onset epilepsy.
- To assess the impact of STAR on seizure outcomes and HRQOL.
Main Methods:
- A randomized controlled trial involving 200 children with new onset epilepsy and their caregivers.
- Participants received either the STAR intervention or an EO intervention for 4 months.
- Adherence was monitored electronically, with assessments at baseline, post-intervention, and 3-, 6-, and 12-month follow-ups.
Main Results:
- The STAR group showed significantly greater adherence at 12 months (82.34%) compared to the EO group (61.77%), a difference of 20.6%.
- The STAR intervention demonstrated a large effect size (d=0.83) for adherence improvement.
- No significant differences were observed between groups in seizure frequency or HRQOL outcomes.
Conclusions:
- The family-tailored STAR intervention effectively enhances and sustains medication adherence in children with new onset epilepsy for up to one year.
- STAR is an efficacious adherence intervention that can be readily integrated into standard pediatric epilepsy care.
- While adherence improved, further research may be needed to impact seizure control and HRQOL directly.
Objective:
This study was undertaken to examine the efficacy of a family-tailored education and problem-solving behavioral intervention, Supporting Treatment Adherence Regimens (STAR), in young children (2-12 years old) with new onset epilepsy compared to an attention control (i.e., education only [EO]) intervention. Participants randomized to the STAR intervention were hypothesized to demonstrate significantly improved adherence at postintervention and 3-, 6-, and 12-month follow-up visits compared to the EO intervention. Seizure and health-related quality of life (HRQOL) outcomes were also examined.
Methods:
Two hundred children with new onset epilepsy and their caregivers were recruited during routine epilepsy clinic visits. Baseline questionnaires were completed, and electronic adherence monitors were provided. Participants with adherence less than 95% during the run-in period were randomized to either STAR or EO intervention. Active intervention was provided to both groups for 4 months. Questionnaires were completed at conclusion of the active intervention phase and three follow-up time points (3, 6, and 12 months). Group differences in adherence, seizure outcomes, and HRQOL were examined using regression-based analyses of covariance and longitudinal mixed effect linear or logistical models.
Results:
Adherence at 12-month follow-up was significantly different between the STAR (mean = 82.34, SD = 21.29) and EO intervention groups (mean = 61.77, SD = 28.29), with the STAR group demonstrating 20.6% greater adherence (b = 19.11, p = .04, 95% confidence interval = 1.00-37.22, d = .83). No significant differences were found between groups in seizure and HRQOL outcomes.
Significance:
A family-based behavioral adherence intervention demonstrated sustained adherence improvements 1 year following epilepsy diagnosis compared to an epilepsy-specific education intervention. STAR is an efficacious adherence intervention that can easily be implemented into routine epilepsy care.
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