HOme-Based Self-management and COgnitive Training CHanges Lives (HOBSCOTCH) -Post-Traumatic Epilepsy (PTE)
HOBSCOTCHPTE
2 other identifiers
interventional
160
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 11, 2022
CompletedFirst Posted
Study publicly available on registry
February 10, 2022
CompletedStudy Start
First participant enrolled
March 21, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
ExpectedMarch 19, 2026
March 1, 2026
3.6 years
January 11, 2022
March 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Change in quality of life as measured by comparing QOLIE-31 scores at baseline and 3 months post-intervention in participants with PTE
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.
Baseline and 3 months post-intervention.
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
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.
Baseline, 3 months, 6 months
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
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.
Baseline and 3 months post-intervention
Secondary Outcomes (17)
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 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 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 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.
- +12 more secondary outcomes
Study Arms (4)
PTE Participant Group 1
EXPERIMENTALPTE 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)
PTE Participant Group 2
OTHERPTE 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)
PTE Caregiver Group 1
EXPERIMENTALCaregiver 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.
PTE Caregiver Group 2
OTHERCaregiver 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.
Interventions
HOBSCOTCH is a home-based self-management program to treat cognitive symptoms and improve quality of life, while minimizing the barriers of access to care. The program is based on Problem Solving Therapy (PST) and teaches problem solving strategies and compensatory mechanisms to help manage cognitive dysfunction and enhance quality of life. HOBSCOTCH-PTE is an adaptation of the HOBSCOTCH program for people with a traumatic brain injury and post-traumatic epilepsy that incorporates education about TBI, PTE, and cognition into the education module.
Select components of the HOBSCOTCH-PTE program delivered to caregivers consist of session 1 of the HOBSCOTCH-PTE (virtual) program (education module), guidance and instructions on utilizing quick relaxation, and session 8 of the HOBSCOTCH-PTE program (program wrap-up and maintenance planning).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- Age 18+
- Caregivers to a patient with a confirmed diagnosis of PTE
- Literate and proficient in English
- Telephone access
- Internet access
- Significant visual impairment precluding reading or writing
- No reliable telephone or internet access
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Related Publications (1)
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.
PMID: 26943948BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Barbara C. Jobst, MD, Dr. Med.
Dartmouth-Hitchcock Medical Center
- PRINCIPAL INVESTIGATOR
Elaine T Kiriakopoulos, MD, MSc
Dartmouth-Hitchcock Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chair, Department of Neurology; Professor of Neurology
Study Record Dates
First Submitted
January 11, 2022
First Posted
February 10, 2022
Study Start
March 21, 2022
Primary Completion
October 31, 2025
Study Completion (Estimated)
December 1, 2026
Last Updated
March 19, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- conclusion of study
- Access Criteria
- The Dartmouth-Hitchcock study team will work directly with the MEW Network Database team at Case Western Reserve University; a current data sharing plan is in place.
The Dartmouth-Hitchcock study team will share data with the MEW Network Database team at Case Western Reserve University. HOBSCOTCH is a part of the Managing Epilepsy Well Network (MEWN), MEWN has been a national leader in developing, testing and disseminating evidence-based epilepsy self-management programs. Collectively, the MEWN has an integrated database using MEW common data elements (e.g., demographics, seizure details, quality of life, depression) (1). Sajatovic, M., B. Wilson, R. Shegog, B.S.B. F, C. Escoffery, B.C. Jobst, E.K. Johnson, R.T. Fraser, R.C. Quarells, and T.M. Spruill, The Managing Epilepsy Well (MEW) network database: Lessons learned in refining and implementing an integrated data tool in service of a national U.S. Research Collaborative. Epilepsy Behav, 2021. 115: p. 107650.