Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT03817229 |
| Other study ID # |
FP00001781 |
| Secondary ID |
R01NR017794-01A1 |
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 15, 2019 |
| Est. completion date |
May 31, 2024 |
Study information
| Verified date |
April 2024 |
| Source |
Children's Hospital Medical Center, Cincinnati |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
