Seizure Rescue Medication (RM) as Part of a Comprehensive Epilepsy Self-management Package of Care

ConditionEpilepsy
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospitals Cleveland Medical Center

About this trial

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

This trial accepts healthy volunteers

Qualifiers

Have epilepsy

Have experience with RM

Be 18 years or older

Be able to speak and understand English

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • SMART RM

    Behavioral

    The SMART-RM will consist of 8 group-format, 45-60 minute sessions (up to 11 participants per group), which will be collaboratively delivered by a Nurse Educator (NE) and a Peer Educator (PE).

  • Valtoco Nasal Product

    Drug

    Medication dosing will follow recommendations in the Valtoco package insert and managed by the epilepsy clinician.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: SMART RMExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Change in number of seizures as measured by patient report.

Time frame
Baseline, 6 months

Secondary outcomes

1

Change in quality of life as measure by QOLIE-31

Quality of life (QOL) will be assessed using the QOLIE-31, a validated tool to assess quality of life specifically in people with epilepsy with higher numbers reflecting a more favorable health state.

Time frame
Baseline, 10 week, 24 week
2

Change in functional status as measure by Short-Form Health Survey (SF-36)

Functional status will be assessed using the 36-item Short-Form Health Survey (SF-36), a multipurpose, short-form health survey with 36 questions that yields two psychometrically based components: a physical component summary and mental component summary. Scores range from 0 (worst functioning) to 100 (best functioning). The SF-36 is a generic measure of functional health status and has proven useful for comparing the relative burden of diseases.

Time frame
Baseline, 10 week, 24 week
3

Change in depressive symptoms as measure by Patient Health Questionnaire (PHQ-9)

Depressive symptom severity will be assessed using the nine- item Patient Health Questionnaire (PHQ-9), a widely used and validated self-rated depression scale. The PHQ-9 incorporates Diagnostic and Statistical Manual of Mental Disorders diagnostic criteria, with scores ranging from 0 to 27. Higher scores indicate worse depression severity. The PHQ-9 has been widely used to measure depressive symptom severity in epilepsy.

Time frame
Baseline, 10 week, 24 week
4

Change in epilepsy self management as measure by Epilepsy Self-Efficacy Scale (ESES)

Self-efficacy will be measured using the 33-item Epilepsy Self-Efficacy Scale (ESES), with scores ranging from 0 to 330 and higher scores indicating better self-efficacy. Social support will be measured with the 12-item.

Time frame
Baseline, 10 week, 24 week

Other outcomes

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