HOBSCOTCH Phase II
- Conditions
- Epilepsy
- Interventions
- Behavioral: Home Based Self-management and Cognitive Training Changes lives (HOBSCOTCH)
- Registration Number
- NCT02394509
- Lead Sponsor
- Dartmouth-Hitchcock Medical Center
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 106
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description HOBSCOTCH-V (virtual) Home Based Self-management and Cognitive Training Changes lives (HOBSCOTCH) Participants 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. HOBSCOTCH-IP (in person) Home Based Self-management and Cognitive Training Changes lives (HOBSCOTCH) Participants 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. Control Home Based Self-management and Cognitive Training Changes lives (HOBSCOTCH) Participants 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.
- Primary Outcome Measures
Name Time Method Change in Quality of Life Baseline and months: 3, 6, 9, 12, 15 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
Change in Healthcare Utilization Baseline and months: 3, 6, 9, 12, 15 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.
- Secondary Outcome Measures
Name Time Method Change in Depression Baseline and months: 3, 6, 9, 12, 15 We will be using the Patient Health Questionnaire (PHQ-9). The PHQ-9 is a brief 9-item validated depression scale.
Change in Cognition Baseline and months: 3, 6, 9, 12, 15 We will be using a modified version of the Brief Test of Adult Cognition by Telephone (BTACT). This is a modified version of a validated psychometric instrument that can be delivered over the phone in 20 minutes. It includes measures of episodic memory, working memory, reasoning, verbal fluency and executive function.
Change in Self-Management Practices Baseline and months: 3, 6, 9, 12, 15 We will be using the Epilepsy Self-Management Scale (ESMS). This is a 38 item scale that assesses use of epilepsy self-management practices.
Change in Cognitive Function Baseline and months: 3, 6, 9, 12, 15 We will be using 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.
Trial Locations
- Locations (4)
Maine Medical Center
🇺🇸Portland, Maine, United States
University of Vermont Medical Center
🇺🇸Burlington, Vermont, United States
University of Massachusetts Medical School
🇺🇸Worcester, Massachusetts, United States
Dartmouth-Hitchcock Medical Center in Lebanon, NH
🇺🇸Lebanon, New Hampshire, United States