Readiness Brain Operation Optimization Training (ReBOOT) for Epilepsy Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Study Attrition
研究概览
简要总结
The goal of this clinical trial is to learn if new educational program prior to epilepsy surgery can either decrease the risk of cognitive decline after surgery or be a help to those patients who experience a decline after undergoing epilepsy surgery.
Participants will participate in 2 individual virtual sessions and 4 virtual group sessions over the course of 5-6 weeks prior to their epilepsy surgery. They will asked to fill out online surveys and questionnaires at various times throughout the study, up to 12 months after their surgery.
To see if the educational program works, researchers will compare those participating in the educational program with those that are receiving the standard epilepsy care prior to surgery.
详细描述
In this prospective, controlled, randomized study, the researchers aim to assess the feasibility and effectiveness of a cognitive intervention in those with epilepsy. They will implement a novel prehabilitation program for patients who have been recommended for epilepsy surgery and will track retention, and adherence to understand the feasibility of the program. Researchers will gather patient data regarding satisfaction with the prehabilitation program and elicit qualitative feedback from patients to further refine the program. To assess intervention efficacy, researchers will compare patients who undergo the prehabilitation program to a treatment-as-usual control group on outcome measures related to quality of life, compensatory strategy use, psychosocial factors, and surgical satisfaction.
The study team will accomplish these objectives by comparing participants that are randomly assigned to the ReBOOT intervention arm (2 individual, virtual sessions and 4 virtual, group sessions over the course of 5-6 weeks) to those participants assigned to the control arm (standard epilepsy care). Researchers will measure the effects and feasibility of the intervention through the use attendance tracking, homework adherence, and health and quality of life questionnaires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults, aged 18-60 years old, with diagnosed epilepsy who have been confirmed as an appropriate surgical candidate by their epileptologist
- •Able to independently provide informed consent
- •Fluent in English
- •Reading abilities at or above 8th grade level as determined by the Wide Range Achievement Test- 4th Edition (WRAT-4), Reading subtest.
- •Internet access and the ability to participate in online video streaming
- •No history of resective or ablative neurosurgery, but this does not include neuromodulation therapies for epilepsy (e.g., RNS, VNS, DBS)
- •Willing and able to participate in cognitive intervention
排除标准
- •Any patient that has engaged in any form of cognitive rehabilitation/intervention within the last 6 months
- •Ongoing litigation related to the cause of epilepsy, unless litigation is related to short term or long-term disability application.
- •Undergoing intensive medical treatment for serious or life-threatening illness (e.g., chemotherapy, etc.) that would impact study participation.
- •Serious psychiatric condition that could interfere with participation, such as schizophrenia, active psychosis, active mania, and current suicidal ideation.
- •Significant hearing and/or vision loss that would preclude them from participating in remote cognitive testing and engaging in the cognitive intervention.
研究组 & 干预措施
Intervention
Participants in this arm will receive 2 one-on-one virtual education sessions as well as 4 virtual group education sessions prior to their epilepsy surgery.
干预措施: ReBOOT program (Behavioral)
Treatment-as-Usual
Treatment as usual but will also receive three brief 5-minute phone calls over 6-weeks after initial enrollment. These phone calls are not therapeutic in nature but provide control participants with brief engagement in study-related activities to ensure that any benefits seen between groups are not simply attributable to study participation.
结局指标
主要结局
Study Attrition
时间窗: 5-6 Weeks post study enrollment
As determined by number of patients who do not complete the ReBOOT program and the reasons why
Intervention attendance
时间窗: 5-6 Weeks post study enrollment
As determined by weekly group attendance and the number of weeks it takes each patient to complete all four rotating sessions
Rate of Homework Completion
时间窗: 5-6 Weeks post study enrollment
As determined by self-reported whether or not patient attempted to complete or completed their homework
Intervention Efficacy based on Quality of Life
时间窗: 5-6 weeks post study enrollment, 6 month, 12 month
As assessed by the Quality of Life in Epilepsy questionnaire (Min/Max: 0-100, higher score means better outcome)
次要结局
- Change in Subjective Cognitive Function(5-6 weeks post study enrollment, 6 month, 12 month)
- Change in Stress(5-6 weeks post study enrollment, 6 month, 12 month)
- Change in Mood(5-6 weeks post study enrollment, 6 month, 12 month)
- Surgery Satisfaction assessed by Epilepsy Surgery Satisfaction Questionnaire(6 month, 12 month)
- Intervention Efficacy based on Functional Status(5-6 weeks post study enrollment, 6 month, 12 month)
- Satisfaction with ReBOOT(5-6 weeks post study enrollment)
- Change in Self-Efficacy(5-6 weeks post study enrollment, 6 month, 12 month)
- Change in Locus of Control(5-6 weeks post study enrollment, 6 month, 12 month)
- Change in Subjective Cognitive Function(5-6 weeks post study enrollment, 6 month, 12 month)
- Change in Stress(5-6 weeks post study enrollment, 6 month, 12 month)
- Change in Mood(5-6 weeks post study enrollment, 6 month, 12 month)
- Surgery Satisfaction assessed by Epilepsy Surgery Satisfaction Questionnaire(6 month, 12 month)
- Intervention Efficacy based on Functional Status(5-6 weeks post study enrollment, 6 month, 12 month)
- Satisfaction with ReBOOT(5-6 weeks post study enrollment)
- Change in Self-Efficacy(5-6 weeks post study enrollment, 6 month, 12 month)
- Change in Locus of Control(5-6 weeks post study enrollment, 6 month, 12 month)
- Change in Word List Recall(Pre-surgery and 6 Months Post-surgery)
- Change in Story Recall(Pre-surgery and 6 Months Post-surgery)
- Change in Visual Memory Recall(Pre-surgery and 6 Months Post-surgery)
- Change in Naming(Pre-surgery and 6 Months Post-surgery)
- Change in Attention(Pre-surgery and 6 Months Post-surgery)
- Change in Problem Solving(Pre-surgery and 6 Months Post-surgery)
- Change in Mental Flexibility(Pre-surgery and 6 Months Post-surgery)
研究者
Kayela Arrotta
Principal Investigator
The Cleveland Clinic