Epilepsy Adherence in Children and Technology (eACT)
- Conditions
- Epilepsy
- Registration Number
- NCT03817229
- Lead Sponsor
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 268
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Anti-seizure Medication Adherence Rate Stage 1 (Month 5) Electronically monitored adherence, as measured by the Simplemed+ pillboxes or Adheretech bottles will be used as the primary outcome to calculate an adherence rate. A monthly adherence rate for antiseizure medication is calculated for Month 5, which ranges from 0-100%, with higher scores reflecting higher adherence.
- Secondary Outcome Measures
Name Time Method Antiseizure Medication Adherence Rate Month 14 lectronically monitored adherence, as measured by the Simplemed+ pillboxes or Adheretech bottles will be used as the primary outcome to calculate an adherence rate. A monthly adherence rate for antiseizure medication is calculated for Month 14, which ranges from 0-100%, with higher scores reflecting higher adherence.
Global Assessment of Severity of Epilepsy Months 14-19 The GASE is a item measure, ranging from 1-7, with 7 representing worse seizure severity. GASE was dichotomized with a 0 or 1 rating. Participants who received a GASE severity score of 1 or 2 were given a 0 score and those who received a GASE score of 3-7 were given a 1 score. In this context, a GASE category of 0 is the lower severity rating.
PedsQL Epilepsy Module-Impact (Parent Report) Month 14 The Pediatric Quality of Life (PedsQL) Epilepsy Module is a 29-item epilepsy-specific HRQOL measure for youth with epilepsy between the ages of 2 and 18 years with excellent reliability and validity. A total of five different subscales comprise this measure, including Cognitive, Impact, Sleep, Executive Functioning, and Mood/Behavior. Parallel and developmentally appropriate forms exist for both youth and their caregiver, who record their answers using a 5-point Likert scale ranging from 0 = never a problem to 4 = almost always a problem. Scores range from 0-100, with higher scores representing better HRQOL. Internal consistency for the subscales range from 0.70 to 0.94.
Seizure Severity Adapted for Children Scale-Total Score Month 14 Seizure Severity Scale Adapted for Children is a measure of seizure severity via parent-report. This caregiver questionnaire is nine-items assessing the child's seizure severity. Items focus on the intrusiveness, frequency, length, and disruptiveness of seizures. Items are scored from 0-3 and a mean is calculated across items for a Total score. Higher scores reflect greater seizure severity.
Seizure Freedom Month 14-17 Seizure Freedom is a dichotomous variable regarding the absence or presence of seizures over a 4 month period of time. Participants were given a score of 0 if they had no seizures and a score of 1 if they had any seizures during that time frame. Thus, a score of 0 represents seizure freedom while a score of 1 represents the presence of seizures.
PedsQL Epilepsy Module-Cognition (Parent Report) Month 14 The Pediatric Quality of Life (PedsQL) Epilepsy Module is a 29-item epilepsy-specific HRQOL measure for youth with epilepsy between the ages of 2 and 18 years with excellent reliability and validity. A total of five different subscales comprise this measure, including Cognitive, Impact, Sleep, Executive Functioning, and Mood/Behavior. Parallel and developmentally appropriate forms exist for both youth and their caregiver, who record their answers using a 5-point Likert scale ranging from 0 = never a problem to 4 = almost always a problem. Scores range from 0-100, with higher scores representing better HRQOL. Internal consistency for the subscales range from 0.70 to 0.94.
PedsQL Epilepsy Module-Sleep (Parent Report) Month 14 The Pediatric Quality of Life (PedsQL) Epilepsy Module is a 29-item epilepsy-specific HRQOL measure for youth with epilepsy between the ages of 2 and 18 years with excellent reliability and validity. A total of five different subscales comprise this measure, including Cognitive, Impact, Sleep, Executive Functioning, and Mood/Behavior. Parallel and developmentally appropriate forms exist for both youth and their caregiver, who record their answers using a 5-point Likert scale ranging from 0 = never a problem to 4 = almost always a problem. Scores range from 0-100, with higher scores representing better HRQOL. Internal consistency for the subscales range from 0.70 to 0.94.
PedsQL Epilepsy Module-Executive Functioning (Parent Report) Month 14 The Pediatric Quality of Life (PedsQL) Epilepsy Module is a 29-item epilepsy-specific HRQOL measure for youth with epilepsy between the ages of 2 and 18 years with excellent reliability and validity. A total of five different subscales comprise this measure, including Cognitive, Impact, Sleep, Executive Functioning, and Mood/Behavior. Parallel and developmentally appropriate forms exist for both youth and their caregiver, who record their answers using a 5-point Likert scale ranging from 0 = never a problem to 4 = almost always a problem. Scores range from 0-100, with higher scores representing better HRQOL. Internal consistency for the subscales range from 0.70 to 0.94.
PedsQL Epilepsy Module-Mood/Behavior (Parent Report) Month 8 The Pediatric Quality of Life (PedsQL) Epilepsy Module is a 29-item epilepsy-specific HRQOL measure for youth with epilepsy between the ages of 2 and 18 years with excellent reliability and validity. A total of five different subscales comprise this measure, including Cognitive, Impact, Sleep, Executive Functioning, and Mood/Behavior. Parallel and developmentally appropriate forms exist for both youth and their caregiver, who record their answers using a 5-point Likert scale ranging from 0 = never a problem to 4 = almost always a problem. Scores range from 0-100, with higher scores representing better HRQOL. Internal consistency for the subscales range from 0.70 to 0.94.
Emergency Room and Urgent Care Visits Combined Months 8-14 Emergency Room and Urgent Care Visits Combined (Healthcare utilization) - Number of emergency room visits based on medical chart review and caregiver report. Higher scores reflect more visits.
Hospitalizations (Healthcare Utilization) Months 8-14 Number of inpatient hospitalization based on medical chart review and caregiver report. Higher numbers mean a higher level of inpatient hospitalizations.
Trial Locations
- Locations (4)
Childrens Hospital of Orange County
🇺🇸Orange, California, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
Nationwide Children's Hospital
🇺🇸Columbus, Ohio, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Childrens Hospital of Orange County🇺🇸Orange, California, United States