HOme-Based Self-management and COgnitive Training CHanges Lives (HOBSCOTCH) -Post-Traumatic Epilepsy (PTE)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Epilepsy, Traumatic
- Sponsor
- Dartmouth-Hitchcock Medical Center
- Enrollment
- 160
- Locations
- 1
- Primary Endpoint
- Change in quality of life as measured by comparing QOLIE-31 scores at baseline and 3 months post-intervention in participants with PTE
- Status
- Active, not recruiting
- Last Updated
- 4 months ago
Overview
Brief Summary
The purpose of this study is to assess the ability of the home-based intervention, HOBSCOTCH-PTE, to improve the quality of life and cognitive function in Service Members, Veterans and civilians with post traumatic epilepsy (PTE). This study will also assess the ability of the HOBSCOTCH-PTE program to improve quality of life in caregivers of PTE patients and to reduce caregiver burden.
Detailed Description
The investigators hypothesis is that the home-based intervention (HOBSCOTCH-PTE) will improve quality of life and cognitive function in Service Members, Veterans and civilians with PTE. The integration of family caregiver participation in the HOBSCOTCH-PTE intervention will reduce caregiver burden and increase caregiver knowledge of their loved one's disease and cognitive challenges they face, ultimately leading to an improvement in caregiver quality of life. The investigators will test the hypothesis by pursuing the following specific aims: Aim 1: Adapt the HOBSCOTCH program education module for delivery to patients with PTE and cognitive challenges. The investigators working hypothesis is that the existing education module of the HOBSCOTCH program can be adapted to address key knowledge areas for patients with TBI and PTE and their caregivers. Aim 2: Evaluate the efficacy of the HOBSCOTCH-PTE program in patients with PTE. The investigators working hypothesis is that the HOBSCOTCH-PTE intervention will improve QOL in PTE patients. The investigators also expect to see improvements in subjective cognition, knowledge, self-efficacy, symptom reduction, and health outcomes. Aim 3: Incorporate family caregivers into select components of the HOBSCOTCH-PTE intervention and evaluate the effects of the HOBSCOTCH-PTE intervention on the caregiver. The investigators working hypothesis is that family caregivers will have improvement in QOL, caregiver burden, and health status as a result of their family member with PTE participating in the HOBSCOTCH-PTE intervention, and by their own participation in the HOBSCOTCH-PTE modules delivering disease specific education and mindfulness skill building exercises.
Investigators
Barbara Jobst
Chair, Department of Neurology; Professor of Neurology
Dartmouth-Hitchcock Medical Center
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Change in quality of life as measured by comparing QOLIE-31 scores at baseline and 3 months post-intervention in participants with PTE
Time Frame: Baseline and 3 months post-intervention.
The Quality of Life in Epilepsy (QOLIE-31) is a validated tool containing 16 multi-item scales which assess health related quality of life, emotional well-being, memory and attention deficits, medication effects, seizure control, psychosocial functioning, and health perception. Scores range from 0 to 100, with a higher score reflecting a higher quality of life.
Change in subjective cognition as measured by comparing NeuroQOL - Cognitive Function sub-scale scores at baseline and 3 months post-intervention in participants with PTE
Time Frame: Baseline, 3 months, 6 months
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 caregiver burden as measured by comparing Zarit Burden Interview scores at baseline and at 3 months post-intervention in caregivers of PTE participants
Time Frame: Baseline and 3 months post-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.
Secondary Outcomes
- Changes in PTE participants' medication adherence as measured by a daily self-reported diary compared at baseline and at 3 months post-intervention.(Recorded daily and compared between baseline and 3 months post-intervention.)
- Changes in PTE participants' self-reports of wellbeing as measured by comparing daily reports of well-being in a diary at baseline and at 3 months post-intervention.(Recorded daily and compared between baseline and 3 months post-intervention.)
- HOBSCOTCH Fidelity and Compliance as measured by completed sessions and completed homework for PTE Participants.(6 months post-intervention (end of study))
- Changes in PTE participant knowledge of their own epilepsy as measured by comparing scores on the Epilepsy Knowledge of Own Condition questionnaire at baseline and 6 months post-intervention.(Baseline and 6 months post-intervention.)
- Changes in PTE Participants' mood as measured by comparing scores on the Patient Health Questionnaire (PHQ-9) at baseline and at 3 months post- intervention.(Baseline and at 3 months post-intervention)
- Changes in seizure frequency (PTE participants) as measured by comparing daily self-reported seizures at baseline and at 3 months post-intervention(Recorded daily and compared between baseline and 3 months-post intervention.)
- Changes in PTE participants' use of memory strategies as measured by a daily self-reported diary compared at baseline and 3 months post-intervention.(Recorded daily and compared between baseline and 3 months post-intervention.)
- Feasibility of HOBSCOTCH program for Caregivers as measured by study attrition and a Participant Satisfaction Survey.(6 months post-intervention (end of study))
- Changes in PTE participants self-efficacy (subjective impression of managing their life with epilepsy) as measured by comparing scores on the Epilepsy Self-Efficacy Scale at baseline and at 3 months post-intervention.(Baseline and 3 months post-intervention.)
- Changes in Caregiver Participants' mood as measured by comparing scores on the Patient Health Questionnaire (PHQ-9) at baseline and at 3 months post- intervention.(Baseline and at 3 months post-intervention)
- Sustainability of improvement on primary outcome measures for PTE Participants by comparing scores on the Cognitive Function sub-scale of the NeuroQOL at 3 months and 6 months post-intervention.(3 months 6 months post intervention.)
- Sustainability of improvement on primary outcome measures for Caregiver Participants by comparing scores on the Zarit Caregiver Burden at 3 months and 6 months post-intervention.(3 months 6 months post intervention.)
- Changes in Caregiver Participants' knowledge of epilepsy as measured by comparing scores on the [Caregiver] General Knowledge of Epilepsy questionnaire at baseline and at 6 months-post intervention.(Baseline and 6 months post-intervention.)
- Sustainability of improvement on primary outcome measure for PTE Participants by comparing scores on the QOLIE-31 at 3 months and 6 months post-intervention.(3 months 6 months post intervention.)
- Engagement and Satisfaction for PTE Participants as measured by analyzing study attrition and a Participant Satisfaction Survey at the end of the study.(6 months post-intervention (end of study))
- Changes in PTE participants' objective cognition as measured by comparing scores on the Montreal Cognitive Assessment (MoCA) at baseline and at 3 months post-intervention.(Baseline and 3 months post-intervention.)
- Changes in caregiver self-reported health status as measured by comparing scores on the Short-Form 36 (SF-36) at baseline and 3 months-post intervention.(Baseline and 3 months post-intervention.)