Seizure Rescue Medication (RM) as Part of a Comprehensive Epilepsy Self-management Package of Care
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Change in number of seizures as measured by patient report.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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 3 seizures but not more than 100 seizures in the previous 6 months. If there have only been 3 seizures in the last 6 months, two of the seizures should be within approximately 24 hours of each other (not more than 48 hours apart)
- •Be able to speak and understand English
- •Be able to provide written, informed consent to study participation
排除标准
- •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
研究组 & 干预措施
SMART RM
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). The intervention will be remotely delivered in a web-based format using a secure web teleconferencing system (such as Zoom) that will allow us to set up a virtual meeting room. Following the group-session series, participants will have 3 monthly telephone maintenance sessions lasting around 15 minutes. Maintenance session web/telephone calls will be made to study participants by a NE with experience in epilepsy and/or chronic health condition management.
干预措施: SMART RM (Behavioral)
SMART RM
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). The intervention will be remotely delivered in a web-based format using a secure web teleconferencing system (such as Zoom) that will allow us to set up a virtual meeting room. Following the group-session series, participants will have 3 monthly telephone maintenance sessions lasting around 15 minutes. Maintenance session web/telephone calls will be made to study participants by a NE with experience in epilepsy and/or chronic health condition management.
干预措施: Valtoco Nasal Product (Drug)
结局指标
主要结局
Change in number of seizures as measured by patient report.
时间窗: Baseline, 6 months
次要结局
- Change in quality of life as measure by QOLIE-31(Baseline, 10 week, 24 week)
- Change in functional status as measure by Short-Form Health Survey (SF-36)(Baseline, 10 week, 24 week)
- Change in depressive symptoms as measure by Patient Health Questionnaire (PHQ-9)(Baseline, 10 week, 24 week)
- Change in epilepsy self management as measure by Epilepsy Self-Efficacy Scale (ESES)(Baseline, 10 week, 24 week)
- Change in number of emergency room visit as measure by patient report(Baseline, 10 week, 24 week)
- Change in number of hospitalizations as measure by patient report(Baseline, 10 week, 24 week)
- Change in epilepsy self management as measure by Multidimensional Scale of Perceived Social Support (MSPSS)(Baseline, 10 week, 24 week)
- Change in epilepsy self management as measure by Epilepsy Self-Management Scale (ESMS)(Baseline, 10 week, 24 week)
- Change in epilepsy self management as measure by Epilepsy Stigma Scale (ESS)(Baseline, 10 week, 24 week)
- Change in number of non study outpatient services utilization as measure by patient report(Baseline, 10 week, 24 week)
研究者
Martha Sajatovic
Physician, UHMG
University Hospitals Cleveland Medical Center