Clinical trial NCT05235061: HOme-Based Self-management and COgnitive Training CHanges Lives (HOBSCOTCH) -Post-Traumatic Epilepsy (PTE)
Official title: HOme-Based Self-management and COgnitive Training CHanges Lives (HOBSCOTCH) -Post-Traumatic Epilepsy (PTE)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Epilepsy, Traumatic
Brain Injuries, Traumatic
Keywords: Epilepsy
Epilepsy, Post-Traumatic
Traumatic Brain Injury
Cognition
Self-Management
Cognitive remediation
Seizures
Memory Disorders
Caregivers
Caregiver Burden
Mindfulness
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2022-02-10
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria/PTE Participants:

* Age 18+
* Diagnosis of post traumatic epilepsy, with controlled or uncontrolled seizures
* Subjective memory complaints
* No changes in antiepileptic and antidepressant medication regimen for 1 month, however brief discontinuation of antiepileptic medicine for inpatient video EEG evaluation is acceptable
* Literate and proficient in English
* Telephone access
* Internet access

Exclusion Criteria/PTE Participants:

* Subjects self-reporting a dementing illness or a mention of a dementing illness in their medical record
* Severe mental disability or estimated IQ less than 70 per clinical judgement
* Significant visual impairment precluding reading or writing
* No reliable telephone or internet access
* No diagnosis of epilepsy

Inclusion Criteria/Caregiver Participants

* Age 18+
* Caregivers to a patient with a confirmed diagnosis of PTE
* Literate and proficient in English
* Telephone access
* Internet access

Exclusion Criteria/Caregiver Participants:

* Significant visual impairment precluding reading or writing
* No reliable telephone or internet access

Primary outcomes:
measure: Change in quality of life as measured by comparing QOLIE-31 scores at baseline and 3 months post-intervention in participants with PTE
timeFrame: Baseline and 3 months post-intervention.
measure: 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
timeFrame: Baseline, 3 months, 6 months
measure: 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
timeFrame: Baseline and 3 months post-intervention
Secondary outcomes:
measure: 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.
timeFrame: Baseline and 6 months post-intervention.
measure: 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.
timeFrame: Baseline and 3 months post-intervention.
measure: 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.
timeFrame: Baseline and 3 months post-intervention.
measure: 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.
timeFrame: Baseline and at 3 months post-intervention
measure: Changes in seizure frequency (PTE participants) as measured by comparing daily self-reported seizures at baseline and at 3 months post-intervention
timeFrame: Recorded daily and compared between baseline and 3 months-post intervention.
measure: Changes in PTE participants' medication adherence as measured by a daily self-reported diary compared at baseline and at 3 months post-intervention.
timeFrame: Recorded daily and compared between baseline and 3 months post-intervention.
measure: Changes in PTE participants' use of memory strategies as measured by a daily self-reported diary compared at baseline and 3 months post-intervention.
timeFrame: Recorded daily and compared between baseline and 3 months post-intervention.
measure: 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.
timeFrame: Recorded daily and compared between baseline and 3 months post-intervention.
measure: 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.
timeFrame: Baseline and 6 months post-intervention.
measure: 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.
timeFrame: Baseline and 3 months post-intervention.
measure: 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.
timeFrame: Baseline and at 3 months post-intervention
measure: 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.
timeFrame: 3 months 6 months post intervention.
measure: 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.
timeFrame: 3 months 6 months post intervention.
measure: 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.
timeFrame: 3 months 6 months post intervention.
measure: Engagement and Satisfaction for PTE Participants as measured by analyzing study attrition and a Participant Satisfaction Survey at the end of the study.
timeFrame: 6 months post-intervention (end of study)
measure: HOBSCOTCH Fidelity and Compliance as measured by completed sessions and completed homework for PTE Participants.
timeFrame: 6 months post-intervention (end of study)
measure: Feasibility of HOBSCOTCH program for Caregivers as measured by study attrition and a Participant Satisfaction Survey.
timeFrame: 6 months post-intervention (end of study)
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Barbara C. Jobst, MD, Dr. Med.
role: PRINCIPAL_INVESTIGATOR
affiliation: Dartmouth-Hitchcock Medical Center
name: Elaine T Kiriakopoulos, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Caller TA, Ferguson RJ, Roth RM, Secore KL, Alexandre FP, Zhao W, Tosteson TD, Henegan PL, Birney K, Jobst BC. A cognitive behavioral intervention (HOBSCOTCH) improves quality of life and attention in epilepsy. Epilepsy Behav. 2016 Apr;57(Pt A):111-117. doi: 10.1016/j.yebeh.2016.01.024. Epub 2016 Mar 2.