Ignite Creation Date:
2025-12-24 @ 12:57 PM
Ignite Modification Date:
2026-01-01 @ 8:24 PM
Study NCT ID:
NCT05235061
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-18
First Post:
2022-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HOme-Based Self-management and COgnitive Training CHanges Lives (HOBSCOTCH) -Post-Traumatic Epilepsy (PTE)
Sponsor:
Dartmouth-Hitchcock Medical Center
Organization:
Study Overview
Official Title:
HOme-Based Self-management and COgnitive Training CHanges Lives (HOBSCOTCH) -Post-Traumatic Epilepsy (PTE)
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HOBSCOTCHPTE
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.
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| W81XW82110279 | OTHER | US Department of Defense | View |