HOBSCOTCH Phase III

Study Overview
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Brief Summary
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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
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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 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.

Official Title
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HOBSCOTCH Phase III: Efficacy of Enhanced Virtual HOBSCOTCH

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+ 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 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

Ages Eligible for Study
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Minimum Age: 18 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-V (virtual)<br>Participants will receive the HOBSCOTCH intervention consisting of 1:1 sessions delivered once per week, including: 1 pre-HOBSCOTCH Session (on webcam) 1 educational session (on webcam) 6 telephone sessions 1 wrap-up session (webcam or telephone) Participants will also receive 3 booster sessions, via webcam or telephone, once per month. | 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 names: HOBSCOTCH;|
| Other: Control<br>Participants will be wait listed and will receive HOBSCOTCH-V (above) 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>* Other names: HOBSCOTCH;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in quality of life | 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. | Baseline and at months 3, 6, 9, 12 | 
| Change in cognitive function | 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. | Baseline and at months 3, 6, 9, 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in depression | The researchers will use the Patient Health Questionnaire (PHQ-9). The PHQ-9 is a brief 9-item validated depression scale. Scores range from 0 to 27. Scores of 5, 10, 15, and 20 represent cut-offs for mild, moderate, moderately severe, and severe depression, respectively. | Baseline and at months 3, 6, 9, 12 | 
| Change in self-management practices | The researchers will use the Adult Epilepsy Self-Management Measurement Instrument (AESMMI-65).This is a 65 item scale that assesses use of epilepsy self-management practices. Scores range from 65 to 325, with a higher score indicating more frequent use of self-management strategies. | Baseline and at months 3, 6, 9, 12 | 
| Changes in self-reported seizure frequency | The researchers will collect seizure information throughout the entire study by use of a smartphone app or paper log to track seizures daily. No range. | Ongoing through entire study baseline - 12 months | 
| Changes in medication adherence | Medication adherence will be collected using the Medication Adherence Rating Scale (MARS), a 10-item inventory to measure medication adherence, as well as by a daily single item medication adherence question through a smartphone app or paper log. For the MARS, scores range from 0 to 10, with a higher score indicating better adherence. | Ongoing through entire study baseline - 12 months, and at baseline and at months 3, 6, 9, 12 | 
| Changes in health confidence | The researchers will use the Health Confidence Score, a 4-item measure of health confidence. Scores range from 0 to 13, with a higher score indicating better health confidence. | Baseline and at months 3, 6, 9, 12 | 
| Changes in healthcare utilization | The researchers will use the Health Care Utilization 4-item measure from the Self-Management Resource Center to capture utilization of health services in the last 6 months. No range. | Baseline and at months 3, 6, 9, 12 | 
| Changes in overall well-being | The researchers will collect daily well-being information throughout the entire study by use of a smartphone app or paper log and a basic single item Likert-scale of well-being. No range. | Ongoing through entire study baseline - 12 months | 

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