Clinical trial NCT02394509: HOBSCOTCH Phase II
Official title: HOBSCOTCH Phase II: A Pragmatic Study of HOBSCOTCH in New England.
Study type: INTERVENTIONAL
Overall status: COMPLETED
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: 2015-03-20
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
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 feasibility and efficacy of the home-based cognitive self-management program "HOBSCOTCH" delivered at four New England medical centers. It will test the long-term impact and cost-effectiveness of HOBSCOTCH, and whether it can be delivered from a distance utilizing e-health tools for parts of the program.

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 II is a replication study of the original HOBSCOTCH study, designed to translate the findings of HOBSCOTCH into a real world setting. This is a multi-center study, with the HOBSCOTCH intervention being implemented at four epilepsy clinics in New England.

Eligibility criteria: Inclusion Criteria:

* Age 18-70
* Confirmed 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

Exclusion Criteria:

* Subjects age 66-70 with a mention of a dementing illness in their medical record
* Severe mental disability or estimated IQ less than 70
* Significant visual impairment precluding reading or writing
* No reliable telephone access

Primary outcomes:
measure: Change in Quality of Life
timeFrame: Baseline and months: 3, 6, 9, 12, 15
measure: Change in Healthcare Utilization
timeFrame: Baseline and months: 3, 6, 9, 12, 15
Secondary outcomes:
measure: Change in Depression
timeFrame: Baseline and months: 3, 6, 9, 12, 15
measure: Change in Cognition
timeFrame: Baseline and months: 3, 6, 9, 12, 15
measure: Change in Self-Management Practices
timeFrame: Baseline and months: 3, 6, 9, 12, 15
measure: Change in Cognitive Function
timeFrame: Baseline and months: 3, 6, 9, 12, 15
Other outcomes:
Locations:
city: Portland
country: United States
facility: Maine Medical Center
state: Maine
city: Worcester
country: United States
facility: University of Massachusetts Medical School
state: Massachusetts
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center in Lebanon, NH
state: New Hampshire
city: Burlington
country: United States
facility: University of Vermont Medical Center
state: Vermont
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center and Dartmouth College
name: Barbara C Jobst, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Streltzov NA, Schmidt SS, Schommer LM, Zhao W, Tosteson TD, Mazanec MT, Kiriakopoulos ET, Chu F, Henninger HL, Nagle K, Roth RM, Jobst B. Effectiveness of a Self-Management Program to Improve Cognition and Quality of Life in Epilepsy: A Pragmatic, Randomized, Multicenter Trial. Neurology. 2022 May 24;98(21):e2174-e2184. doi: 10.1212/WNL.0000000000200346. Epub 2022 Apr 6.