Clinical trial NCT04519775: HOBSCOTCH Phase III
Official title: HOBSCOTCH Phase III: Efficacy of Enhanced Virtual HOBSCOTCH
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Epilepsy
Keywords: Epilepsy Memory Problems
Self-Management
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2020-08-20
Enrollment: 140
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 determine the efficacy of an entirely virtual version of the home-based cognitive self-management program "HOBSCOTCH." It will test whether HOBSCOTCH can be delivered nationally from a distance utilizing e-health tools (telephone, computer, and phone).

Detailed description: HOBSCOTCH (Home Based Self-management and Cognitive Training Changes lives) 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 Phase III is a study to examine an entirely virtual version of the program. While HOBSCOTCH was shown to be effective as an in-person and telephone-based program in previous trials (HOBSCOTCH Phase I and II), this study aims to test a version of the program adapted for entirely virtual delivery. This is a single-center study, with the HOBSCOTCH intervention being delivered by staff affiliated with Dartmouth-Hitchcock Medical Center in Lebanon, NH.

Eligibility criteria: Inclusion Criteria:

* Age 18+
* Diagnosis of 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
* Telephone access
* Internet access

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in quality of life
timeFrame: Baseline and at months 3, 6, 9, 12
measure: Change in cognitive function
timeFrame: Baseline and at months 3, 6, 9, 12
Secondary outcomes:
measure: Change in depression
timeFrame: Baseline and at months 3, 6, 9, 12
measure: Change in self-management practices
timeFrame: Baseline and at months 3, 6, 9, 12
measure: Changes in self-reported seizure frequency
timeFrame: Ongoing through entire study baseline - 12 months
measure: Changes in medication adherence
timeFrame: Ongoing through entire study baseline - 12 months, and at baseline and at months 3, 6, 9, 12
measure: Changes in health confidence
timeFrame: Baseline and at months 3, 6, 9, 12
measure: Changes in healthcare utilization
timeFrame: Baseline and at months 3, 6, 9, 12
measure: Changes in overall well-being
timeFrame: Ongoing through entire study baseline - 12 months
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center and Dartmouth College
name: Barbara Jobst, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Caller TA, Secore KL, Ferguson RJ, Roth RM, Alexandre FP, Henegan PL, Harrington JJ, Jobst BC. Design and feasibility of a memory intervention with focus on self-management for cognitive impairment in epilepsy. Epilepsy Behav. 2015 Mar;44:192-4. doi: 10.1016/j.yebeh.2014.12.036. Epub 2015 Feb 27.
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.