Clinical trial NCT06346262: Seizure Rescue Medication (RM) As Part of a Comprehensive Epilepsy Self-management Package of Care
Official title: Seizure Rescue Medication (RM) As Part of a Comprehensive Epilepsy Self-management Package of Care
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Epilepsy
Keywords: Epilepsy Self Management
Epilepsy
Seizure
Reduction medication
Anti-seizure medication
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
First posted: 2024-04-04
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study will be done in two phases. Using stakeholder input (community advisory board (CAB)), the study team will adapt the SMART program to incorporate education and self-management support for use of Rescue Medication (RM) to manage seizure occurrence among Persons With Epilepsy (PWE) who have repetitive seizures. Additional content/support materials, pending input stakeholder might include posters/hand-outs that present information on the use of RM in a way that is engaging and salient to PWE. It is expected that participants will be in Phase 1 for about 3 months and participate in the CAB 2 or 3 times via zoom for 60-90 minutes/meeting. The advisory board will provide input on needed refinement of an adapted version of SMART based on their individual experiences. It is anticipate the total time commitment to be no more than 6 hours over 3 months, spread out over 2-3 meetings with review of materials possible in between meetings.

Phase 2: The investigators will use a 6-month prospective trial design to test engagement with and effects of SMART-RM among approximately 35 adult (≥ 18 years) PWE who have repetitive seizures.


Eligibility criteria: Inclusion Criteria:

Phase 1 Patient with epilepsy inclusion criteria:

* Have epilepsy
* Have experience with RM
* Be 18 years or older
* Be able to speak and understand English
* Be able to provide written, informed consent to study participation

Phase 1 Caregiver inclusion criteria

* Provide care support to an individual with epilepsy
* Be 18 years or older
* Be able to speak and understand English
* Be able to provide written, informed consent to study participation

Phase 1 Provider inclusion criteria

* Provide care for individuals with epilepsy - this may include (not limited to) physician, nurse practitioner, physician assistant, nurse, social worker, psychologist
* Be 18 years or older
* Be able to speak and understand English
* Be able to provide written, informed consent to study participation

Inclusion criteria for PEs:

* Have epilepsy
* Have experience with RM
* Be 18 years or older
* Be able to speak and understand English
* Be able to provide written, informed consent to study participation

Inclusion criteria for participants who will receive SMART-RM:

* Have received a previous diagnosis of epilepsy
* Be adults ≥ age 18,
* While on a regimen of anti-epileptic medication, still be experiencing bouts of seizures (e.g. frequent break through or acute repetitive seizures) distinct from their usual seizure pattern , and, in the opinion of the study epilepsy clinician, may need benzodiazepine intervention for seizure control
* Have experienced at least 5 seizures but not more than 100 seizures in the previous 6 months.
* Be able to speak and understand English
* Be able to provide written, informed consent to study participation

Exclusion Criteria:

Exclusion criteria for participants who will receive SMART-RM:

* Individuals who have had allergic reaction to diazepam or who have medical/psychiatric that are contraindications to the use of diazepam
* Individuals prescribed opioid medications
* Individuals with acute narrow angle glaucoma
* Individuals with known dependence on benzodiazepines or current benzodiazepine abuse.
* Actively suicidal/homicidal
* Individuals with a diagnosis of dementia
* Individuals who are unable to provide written informed consent to participate in study and who do not have a legally authorized representative or individuals who are unable to participate in study procedures.
* Pregnant women

Primary outcomes:
measure: Change in number of seizures as measured by patient report.
timeFrame: Baseline, 6 months
Secondary outcomes:
measure: Change in quality of life as measure by QOLIE-31
timeFrame: Baseline, 10 week, 24 week
measure: Change in functional status as measure by Short-Form Health Survey (SF-36)
timeFrame: Baseline, 10 week, 24 week
measure: Change in depressive symptoms as measure by Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline, 10 week, 24 week
measure: Change in epilepsy self management as measure by Epilepsy Self-Efficacy Scale (ESES)
timeFrame: Baseline, 10 week, 24 week
measure: Change in epilepsy self management as measure by Multidimensional Scale of Perceived Social Support (MSPSS)
timeFrame: Baseline, 10 week, 24 week
measure: Change in epilepsy self management as measure by Epilepsy Self-Management Scale (ESMS)
timeFrame: Baseline, 10 week, 24 week
measure: Change in epilepsy self management as measure by Epilepsy Stigma Scale (ESS)
timeFrame: Baseline, 10 week, 24 week
measure: Change in number of emergency room visit as measure by patient report
timeFrame: Baseline, 10 week, 24 week
measure: Change in number of hospitalizations as measure by patient report
timeFrame: Baseline, 10 week, 24 week
measure: Change in number of non study outpatient services utilization as measure by patient report
timeFrame: Baseline, 10 week, 24 week
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Medical Center
state: Ohio
Study officials:
affiliation: University Hospitals
name: Martha Sajatovic, MD
role: PRINCIPAL_INVESTIGATOR
References: