Epilepsy
Conditions
Keywords
Epilepsy Memory Problems, Self-Management
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.
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.
Sponsors
Centers for Disease Control and Prevention
Dartmouth-Hitchcock Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed