Epilepsy Clinical Trial
— Beat!Official title:
Beat!: A Randomized Controlled Clinical Trial
Verified date | September 2022 |
Source | Children's Hospital Medical Center, Cincinnati |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Non-adherence to antiepileptic drug therapy is a significant problem for adolescents with epilepsy and has a critical impact on health and patient-reported outcomes. Evidence-based adherence interventions are lacking in this population and are critically needed. This proposal seeks to develop and evaluate a mHealth social norms adherence intervention for adolescents with epilepsy.
Status | Completed |
Enrollment | 104 |
Est. completion date | August 16, 2021 |
Est. primary completion date | March 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 13 Years to 17 Years |
Eligibility | Inclusion Criteria: - Ages 13-17 - Confirmed diagnosis of epilepsy - Antiepileptic drug monotherapy - Ability to read and speak English Exclusion Criteria: - No significant developmental delay (e.g., autism, moderate/severe developmental or intellectual disability) or comorbid medical diagnoses (e.g., diabetes) |
Country | Name | City | State |
---|---|---|---|
United States | Nationwide Children's Hospital | Columbus | Ohio |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital Medical Center, Cincinnati | National Institute of Nursing Research (NINR), Nationwide Children's Hospital |
United States,
Modi AC, Patel AD, Stevens J, Smith G, Huszti H, Guilfoyle SM, Mara CA, Schmidt M, Wagner JL. The psychosocial impact of COVID-19 within the first six months of the pandemic on youth with epilepsy and their caregivers. Epilepsy Behav. 2021 Apr;117:107855. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Satisfaction-Teen Report Total Score | Adolescents completed this study specific Satisfaction measure, which was 23-items. This measure assesses satisfaction with the intervention content, relevance, helpfulness, and ease of use. Assessment of perceptions of the impact of what was learned from the intervention were also assessed. Eighteen of the items used a Likert format with the following ratings: Strongly Disagree, Disagree, Agree, and Strongly Agree. A total scale was calculated for the 18 items, which ranges from 18-72, with higher scores reflecting higher satisfaction. Finally, five open-ended items assessing what was most and least helpful about the intervention, what changes adolescents want to see in the intervention, and any additional input. | Month 7 | |
Primary | Electronically Monitored Adherence | A total mean adherence rates will be calculated based on daily adherence rates captured through the SimpleMed Pillboxes or AdhereTech bottles. Scores range from 0-100%, with higher scores representing better adherence. | Month 7 | |
Secondary | Seizure Severity-Clinician Report | The Global Assessment of Severity of Epilepsy (GASE) is a one item clinician-rated measure of seizure severity. The total score ranges from 1-7, with higher scores representing more severe epilepsy | Month 9 | |
Secondary | Seizure Severity-Parent Report | The Seizure Severity Scale-Adapted for Children is a caregiver-reported questionnaire, which is 9-items and assess seizure severity, including intrusiveness, frequency, length, and disruptiveness of seizures. A total score is calculated, ranging from 0-3, with higher scores representing worse seizure severity. | Month 9 | |
Secondary | PedsQL Epilepsy Module - Parent Report | The PedsQL-Epilepsy Module is a 29 item measure with several subscales (Impact, Cognitive, Executive Functioning, Sleep, Mood/Behavior) will be used. Scores range from 0-100 for each subscale, with higher scores representing better quality of life. | Month 9 | |
Secondary | PedsQL Epilepsy Module-Adolescent Report | The PedsQL Epilepsy Module is a 29-item health-related quality of life instrument with five subscales, including Impact, Cognitive, Executive Functioning, Sleep, and Mood/Behavior). Scores range from 0-100, with higher scores representing better quality of life. | 9-month |
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