HOBSCOTCH-YOUTH and Young Adults
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Change in quality of life as measured by comparing QOLIE-10 scores at baseline to 3 months and 6 months post HOBSCOTCH intervention in young adults with epilepsy (YAWE)
研究概览
简要总结
The goal of this clinical trial is to learn more about the home-based epilepsy self-management program, HOBSCOTCH, for improving cognitive function (thinking and memory) and quality of life specifically in young adults, ages 18 - 29 years, who have epilepsy. It will also learn if a modification of the program for youth with epilepsy, ages 13 - 17, improves thinking and memory and quality of life and reduces stress for their parents.
Researchers will enroll 260 young adults with epilepsy and 40 youth with epilepsy and their parent or guardian. Researchers will compare responses to questionnaires and surveys before and after participation in the HOBSCOTCH program to see if thinking, memory and quality of life have improved for young adults and youth with epilepsy and to see if parents have improved quality of life as well.
Participants will:
- Attend 9 weekly one-hour sessions of the HOBSCOTH program in their homes with a one-on-one coach using their computer or their phone; youth with epilepsy (ages 13 - 17) will attend alongside a parent or legal guardian.
- Keep a short daily diary about their seizures and activity in the program using a smart phone app(lication)
- Complete surveys and questionnaires before HOBSCOTCH and 3 months and 6 months later.
There are no study visits to a medical center. HOBSCOTCH is a virtual or telehealth intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 29 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria for Young Adults with Epilepsy (YAWE) and Youth with Epilepsy (YWE):
- •Age 18 - 29 years for YAWE
- •Age 13 - 17 years for YWE
- •For YWE at least one parent or legal guardian provides consent and agrees to participate
- •Diagnosis of epilepsy (controlled or uncontrolled seizures)
- •Subjective cognitive complaints (memory, attention, learning, problem solving, executive function, planning)
- •Literate and proficient in English
- •Telephone access
- •Internet Access.
- •Inclusion Criteria for Parent of Youth with Epilepsy (YWE):
- •Parent or legal guardian of a youth with epilepsy (age 13 - 17 years)
- •Literate and proficient in English
- •Telephone access
- •Internet Access
排除标准
- •Active psychosis (any participant)
- •Illicit substance abuse (any participant)
- •Severe cognitive/intellectual disability (any participant)
- •YWE cannot participate without a parent and parent's consent (or legal guardian)
- •YWE cannot participate without assent even if a parent or legal guardian gives consent
研究组 & 干预措施
HOBSCOTCH-YOUTH and Young Adults Intervention
Participants will receive the HOBSCOTCH (ages 18-29) or HOBSCOTCH-YOUTH (ages 13 -17) program consisting of 1:1 sessions delivered once per week including:
- 1 pre-HOBSCOTCH Session (on webcam or by phone);
- 1 educational session (on webcam);
- 6 HOBSCOTCH intervention sessions (webcam or by phone);
- 1 wrap-up and maintenance planning session.
干预措施: HOBSCOTCH/HOBSCOTCH-YOUTH (Other)
结局指标
主要结局
Change in quality of life as measured by comparing QOLIE-10 scores at baseline to 3 months and 6 months post HOBSCOTCH intervention in young adults with epilepsy (YAWE)
时间窗: Baseline, 3 months and 6 months post HOBSCOTCH intervention
The QOLIE-10 (Quality of Life in Epilepsy Inventory-10) is a validated 10-item, patient-reported questionnaire designed to assess health-related quality of life in adults and adolescents with epilepsy, focusing on core aspects such as seizure worries, daily activities, mood, energy, and medication effects. Numerical responses are summed and divided by the total number of items answered with lower scores reflecting better quality of life or fewer perceived difficulties.
Change in subjective cognition as measured by comparing NeuroQOL - Cognitive Function sub-scale scores at baseline to 3 months and 6 months post HOBSCOTCH intervention in young adults with epilepsy (YAWE)
时间窗: Baseline, 3 months and 6 months post HOBSCOTCH intervention
The Cognitive Function sub-scale of the NeuroQOL is a brief validated tool developed by the NIH for use in patients with neurological disease. Scores range from 8 to 40, with a higher score indicating better reported cognitive functioning.
Change in quality of life as measured by comparing QOLIE-AD-48 scores at baseline to 3 months and 6 months post- HOBSCOTCH-YOUTH intervention in youth with epilepsy (YWE)
时间窗: Baseline, 3 months and 6 months post HOBSCOTCH-YOUTH intervention
The Quality of Life in Epilepsy Inventory for Adolescents (QOLIE-AD-48) is a validated instrument designed to measure health-related quality of life (HRQOL) in adolescents aged 11-18 years with epilepsy. It consists of 8 domains and is scored based on a 5-point Likert scale response from 1 - 5 (very poor - excellent). Higher scores reflect better functioning or quality of life.
Change in caregiver burden for parent/legal guardian of youth with epilepsy as measured by comparing Zarit Burden Interview scores at baseline to 3 months and 6 months post-HOBSCOTH-YOUTH intervention by their child
时间窗: Baseline, 3 months and 6 months post-HOBSCOTCH-YOUTH intervention
The Zarit Burden Interview is a 22-item questionnaire designed to measure the extent to which a caregiver perceives his or her level of burden as a result of caring for a person with a particular diagnosis. A 5-point Likert scale is used with a higher score indicating a greater level of perceived burden.
Change in quality of life as measured by comparing QOLIE-31 scores at baseline to 3 months and 6 months post HOBSCOTCH intervention in young adults with epilepsy (YAWE)
时间窗: Baseline, 3 months and 6 months post HOBSCOTCH intervention
The QOLIE-31 (Quality of Life in Epilepsy Inventory-31) is a validated 31-item, patient-reported questionnaire designed to assess health-related quality of life in adults and adolescents with epilepsy, focusing on core aspects such as seizure worries, daily activities, mood, energy, and medication effects. Numerical responses are summed and divided by the total number of items answered with lower scores reflecting better quality of life or fewer perceived difficulties.
次要结局
- Change in epilepsy self-management practices as measured by comparing the Adult Epilepsy Self-Management Measurement Instrument (AESMMI-65) scores at baseline to 3 months and 6 months post HOBSCOTCH intervention in young adults with epilepsy (YAWE).(Baseline, 3 months and 6 months post HOBSCOTCH intervention)
- Changes in functional memory as measured by comparing Everyday Memory Questionnaire - Revised (EMQ-R) scores at baseline to 3 months and 6 months post HOBSCOTCH intervention in young adults with epilepsy (YAWE).(Baseline, 3 months and 6 months post HOBSCOTCH intervention)
- Changes in perceived self-stigma as measured by comparing Epilepsy Self-Stigma Scale (ESS) scores at baseline to 3 months and 6 months post HOBSCOTCH intervention in young adults with epilepsy (YAWE).(Baseline, 3 months and 6 months post HOBSCOTCH intervention)
- Changes in mood and depression as measured by Patient Health Questionnaire-8 (PHQ-8) scores at baseline to 3 months and 6 months post HOBSCOTCH intervention in young adults with epilepsy (YAWE).(Baseline, 3 months and 6 months post HOBSCOTCH intervention)
- Changes in anxiety by comparing Brief-Epilepsy Anxiety Survey Instrument (brEASI) at baseline to 3 months and 6 months post HOBSCOTCH intervention in young adults with epilepsy (YAWE).(Baseline, 3 months and 6 months post HOBSCOTCH intervention)
- Changes in perceived personal impact of epilepsy as measured by Personal Impact of Epilepsy Scale (PIES) scores at baseline to 3 months and 6 months post HOBSCOTCH intervention in young adults with epilepsy (YAWE).(Baseline, 3 months and 6 months post HOBSCOTCH intervention)
- Change in executive function as measured by comparing Behavioral Rating Inventory of Executive Function - Self Report (BRIEF-SR) scores at baseline to 3 months and 6 months post HOBSCOTCH intervention in youth with epilepsy (YWE).(Baseline, 3 months and 6 months post HOBSCOTCH-YOUTH intervention)
- Change in parent's perception of child's executive function as measured by Behavioral Rating Inventory of Executive Function - Parent Report at baseline to 3 months and 6 months post HOBSCOTCH-YOUTH intervention.(Baseline, 3 months and 6 months post-HOBSCOTCH-YOUTH intervention)
- Changes in perceived self-stigma in parents of youth with epilepsy as measured by comparing Affiliate Stigma Scale scores at baseline to 3 months and 6 months post HOBSCOTCH-YOUTH intervention.(Baseline, 3 months and 6 months post-HOBSCOTCH-YOUTH intervention)
- Changes in frequency of seizures as measured by comparing daily self-reported seizures at baseline to 3 months post-HOBSCOTCH/HOBSCOTCH-YOUTH intervention in young adults and in youth with epilepsy (YAWE and YWE).(Recorded daily and compared between baseline and 3 months-post HOBSCOTCH/HOBSCOTCH-YOUTH intervention)
- Changes in medication adherence as measured by a daily self-reported diary compared at baseline and at 3 months post-HOBSCOTCH/HOBSCOTCH-YOUTH intervention in young adults and in youth with epilepsy (YAWE and YWE).(Recorded daily and compared between baseline and 3 months-post HOBSCOTCH/HOBSCOTCH-YOUTH intervention)
- Changes in use of memory strategies as measured by comparing daily self-reported use of memory strategies at baseline to 3 months post-HOBSCOTCH/HOBSCOTCH-YOUTH intervention in young adults and in youth with epilepsy (YAWE and YWE).(Recorded daily and compared between baseline and 3 months-post HOBSCOTCH/HOBSCOTCH-YOUTH intervention)
- Changes in self-reports of wellbeing as measured by comparing daily reports of well-being at baseline and at 3 months post-HOBSCOTCH/HOBSCOTCH-YOUTH intervention in young adults and youth with epilepsy (YAWE and YWE).(Recorded daily and compared between baseline and 3 months-post HOBSCOTCH/HOBSCOTCH-YOUTH intervention)
- Engagement and satisfaction for young adults with epilepsy (YAWE) and for youth with epilepsy (YWE) and their parents as measured by study attrition and a Participant Satisfaction Survey after completing the HOBSCOTCH/HOBSCOTCH-YOUTH intervention.(At 3 months, i.e. after completing the HOBSCOTCH or HOBSCOTCH-YOUTH intervention)
- Engagement and satisfaction for young adults with epilepsy (YAWE) as measured by CollaboRATE score post HOBSCOTCH intervention.(3 months, i.e. after completing the HOBSCOTCH intervention)
- Engagement and satisfaction for parents of youth with epilepsy (YWE) as measured by CollaboRATE-parent score post HOBSCOTCH intervention.(3 months, i.e. after completing the HOBSCOTCH-YOUTH intervention)
- HOBSCOTCH/HOBSCOTCH-YOUTH fidelity as measured by young adults with epilepsy (YAWE) and youth with epilepsy's (YWE) compliance with weekly homework assignments.(Week 1 through Week 8 of HOBSCOTCH/HOBSCOTCH-YOUTH intervention)
- Sustainability of improvement on primary outcome measure of quality of life for young adults with epilepsy (YAWE) by comparing scores on the QOLIE-10 (Quality of Life in Epilepsy Inventory) at 3 months and 6 months post HOBSCOTCH intervention.(3 months and 6 months post HOBSCOTCH intervention)
- Sustainability of improvement on primary outcome measure of subjective cognition for young adults with epilepsy (YAWE) by comparing scores on the Neuro-QOL Cognitive Subscale at 3 months and 6 months post HOBSCOTCH intervention.(3 months and 6 months post HOBSCOTCH intervention)
- Sustainability of improvement on primary outcome measure of quality of life for youth with epilepsy (YWE) by comparing scores on the QOLIE-AD-48 at 3 months and 6 months post HOBSCOTCH-YOUTH intervention.(3 months and 6 months post HOBSOTCH-YOUTH intervention)
- Sustainability of improvement on primary outcome measure of caregiver burden for parent/legal guardian of youth with epilepsy as measured by comparing Zarit Burden Interview scores at 3 months and 6 months post-HOBSCOTH-YOUTH intervention by their child.(3 months and 6 months post HOBSCOTCH-YOUTH intervention)
- Engagement and satisfaction for young adults with epilepsy (YAWE) as measured by CollaboRATE score post HOBSCOTCH intervention.(Baseline and at 3 months, i.e. after completing the HOBSCOTCH intervention)
- Engagement and satisfaction for parents of youth with epilepsy (YWE) as measured by CollaboRATE-parent score post HOBSCOTCH intervention.(Baseline and at 3 months, i.e. after completing the HOBSCOTCH-YOUTH intervention)
研究者
Elaine T. Kiriakopoulos
Associate Professor, Departments of Neurology, Health Policy & Clinical Practice Dartmouth-Hitchcock Health | Geisel School of Medicine at Dartmouth
Dartmouth-Hitchcock Medical Center