HOme-Based Self-management and COgnitive Training CHanges Lives (HOBSCOTCH) -Post-Traumatic Epilepsy (PTE) (HOBSCOTCHPTE)

Dartmouth Health

Status: Active, not recruiting

Conditions: Epilepsy, Traumatic; Brain Injuries, Traumatic

Treatments: Behavioral: HOBSCOTCH-PTE for Caregivers; Behavioral: Home Based Self-management and Cognitive Training Changes lives in post traumatic epilepsy (HOBSCOTCH-PTE)

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT05235061

STUDY02001238

W81XW82110279 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 4 patient groups

PTE Participant Group 1

Experimental group

Description:

PTE Participant Group 1 will receive the HOBSCOTCH-PTE intervention consisting of 1:1 sessions delivered once per week including: * 1 pre-HOBSCOTCH Session (on webcam) * 1 educational session (on webcam) * 6 telephone sessions * 1 wrap-up session (webcam or telephone)

Treatment:

Behavioral: Home Based Self-management and Cognitive Training Changes lives in post traumatic epilepsy (HOBSCOTCH-PTE)

PTE Participant Group 2

Other group

Description:

PTE Participant Group 2 will be on a 3-month wait list after which they will receive HOBSCOTCH-PTE consisting of 1:1 sessions delivered once per week including: * 1 pre-HOBSCOTCH Session (on webcam) * 1 educational session (on webcam) * 6 telephone sessions * 1 wrap-up session (webcam or telephone)

Treatment:

Behavioral: Home Based Self-management and Cognitive Training Changes lives in post traumatic epilepsy (HOBSCOTCH-PTE)

PTE Caregiver Group 1

Experimental group

Description:

Caregiver Group 1 will receive an adapted version of HOBSCOTCH-PTE by attending session 1 of the HOBSCOTCH-PTE (virtual) program with their PTE patient as well as guidance and instructions on utilizing quick relaxation. Caregiver Group 1 will also attend session 8 of the program with the PTE patient to focus on program wrap-up and maintenance planning.

Treatment:

Behavioral: HOBSCOTCH-PTE for Caregivers

PTE Caregiver Group 2

Other group

Description:

Caregiver Group 2 will be on a 3 month wait list with their PTE patient after which time they will receive an adapted version of HOBSCOTCH-PTE by attending session 1 of the HOBSCOTCH-PTE (virtual) program with their PTE patient as well as guidance and instructions on utilizing quick relaxation. Caregiver Group 2 will also attend session 8 of the program with the PTE patient to focus on program wrap-up and maintenance planning.

Treatment:

Behavioral: HOBSCOTCH-PTE for Caregivers