HOBSCOTCH Phase II

Study Overview
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Brief Summary
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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
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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.

Official Title
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HOBSCOTCH Phase II: A Pragmatic Study of HOBSCOTCH in New England.

Conditions
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Epilepsy

Intervention / Treatment
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* Behavioral: Home Based Self-management and Cognitive Training Changes lives (HOBSCOTCH)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HOBSCOTCH-IP (in person)<br>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. | Behavioral: Home Based Self-management and Cognitive Training Changes lives (HOBSCOTCH)<br>* 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.<br>|
| Experimental: HOBSCOTCH-V (virtual)<br>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. | Behavioral: Home Based Self-management and Cognitive Training Changes lives (HOBSCOTCH)<br>* 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.<br>|
| Other: Control<br>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. | Behavioral: Home Based Self-management and Cognitive Training Changes lives (HOBSCOTCH)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Depression | We will be using the Patient Health Questionnaire (PHQ-9). The PHQ-9 is a brief 9-item validated depression scale. | Baseline and months: 3, 6, 9, 12, 15 | 
| Change in Cognition | 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. | Baseline and months: 3, 6, 9, 12, 15 | 
| Change in Self-Management Practices | We will be using the Epilepsy Self-Management Scale (ESMS). This is a 38 item scale that assesses use of epilepsy self-management practices. | Baseline and months: 3, 6, 9, 12, 15 | 
| Change in Cognitive Function | 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. | Baseline and months: 3, 6, 9, 12, 15 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epilepsy Memory Problems, Self-Management