HOBSCOTCH Phase III: Efficacy of Enhanced Virtual HOBSCOTCH
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 140
- Locations
- 2
- Primary Endpoint
- Change in quality of life
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
- •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
Outcomes
Primary Outcomes
Change in quality of life
Time Frame: Baseline and at months 3, 6, 9, 12
The researchers will use the 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. Scores range from 0 to 100, with a higher score reflecting a higher quality of life.
Change in cognitive function
Time Frame: Baseline and at months 3, 6, 9, 12
The researchers will use the Cognitive Function sub-scale of the NeuroQOL. This 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.
Secondary Outcomes
- Changes in self-reported seizure frequency(Ongoing through entire study baseline - 12 months)
- Changes in medication adherence(Ongoing through entire study baseline - 12 months, and at baseline and at months 3, 6, 9, 12)
- Changes in overall well-being(Ongoing through entire study baseline - 12 months)
- Change in self-management practices(Baseline and at months 3, 6, 9, 12)
- Change in depression(Baseline and at months 3, 6, 9, 12)
- Changes in health confidence(Baseline and at months 3, 6, 9, 12)
- Changes in healthcare utilization(Baseline and at months 3, 6, 9, 12)
Investigators
Barbara Jobst
Staff Physician, Neurology
Dartmouth-Hitchcock Medical Center