HOBSCOTCH Phase II
1 other identifier
interventional
106
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2015
Longer than P75 for not_applicable
4 active sites
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
Study Start
First participant enrolled
March 1, 2015
CompletedFirst Submitted
Initial submission to the registry
March 6, 2015
CompletedFirst Posted
Study publicly available on registry
March 20, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2019
CompletedAugust 20, 2020
August 1, 2020
4.5 years
March 6, 2015
August 19, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in Quality of Life
We will be using Quality of Life in Epilepsy (QOLIE-31). This validated tool contains 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
Baseline and months: 3, 6, 9, 12, 15
Change in Healthcare Utilization
We will be using the Healthcare Utilization in Epilepsy (HCU-E). This validated survey is concordant with billing data. It assesses seizure frequency and whether the subject had received any of the following services because of their epilepsy over the past 3 months: hospital ER services, general practice or family doctor visits, neurologist or epilepsy specialist visits, and overnight hospital inpatient stay.
Baseline and months: 3, 6, 9, 12, 15
Secondary Outcomes (4)
Change in Depression
Baseline and months: 3, 6, 9, 12, 15
Change in Cognition
Baseline and months: 3, 6, 9, 12, 15
Change in Self-Management Practices
Baseline and months: 3, 6, 9, 12, 15
Change in Cognitive Function
Baseline and months: 3, 6, 9, 12, 15
Study Arms (3)
HOBSCOTCH-IP (in person)
EXPERIMENTALParticipants will receive the HOBSCOTCH intervention consisting of a first session conducted in-person, 3 weekly followed by 3 bi-weekly telephone coaching sessions, and a final session conducted in-person.
HOBSCOTCH-V (virtual)
EXPERIMENTALParticipants will receive the HOBSCOTCH intervention consisting of a first session conducted virtually, 3 weekly followed by 3 bi-weekly telephone coaching sessions, and a final session conducted virtually.
Control
OTHERParticipants will be wait listed and given an option whether they prefer to enroll into HOBSCOTCH-IP or HOBSCOTCH-V. Subjects in Group 3 will receive HOBSCOTCH following a 6 month wait period.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Maine Medical Center
Portland, Maine, 04102, United States
University of Massachusetts Medical School
Worcester, Massachusetts, 01655, United States
Dartmouth-Hitchcock Medical Center in Lebanon, NH
Lebanon, New Hampshire, 03766, United States
University of Vermont Medical Center
Burlington, Vermont, 05401, United States
Related Publications (1)
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.
PMID: 35387855DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Barbara C Jobst, MD
Dartmouth-Hitchcock Medical Center and Dartmouth College
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
- Staff Physician, Neurology
Study Record Dates
First Submitted
March 6, 2015
First Posted
March 20, 2015
Study Start
March 1, 2015
Primary Completion
September 1, 2019
Study Completion
September 1, 2019
Last Updated
August 20, 2020
Record last verified: 2020-08