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HOBSCOTCH Program for Epilepsy

N/A

Waitlist Available

Led By Barbara Jobst, MD

Research Sponsored by Dartmouth-Hitchcock Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of epilepsy, with controlled or uncontrolled seizures

Be older than 18 years old

Must not have

No diagnosis of epilepsy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and at months 3, 6, 9, 12

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether HOBSCOTCH, a home-based cognitive self-management program, is effective when delivered virtually using e-health tools.

Who is the study for?

This trial is for adults over 18 with epilepsy who can read and have access to a phone and the internet. They should be on a stable medication regimen for at least one month, although brief stops for specific tests are okay. Participants must also have memory concerns but cannot have dementia, severe mental disability, significant visual impairments, or lack reliable communication tools.

What is being tested?

The HOBSCOTCH Phase III trial is testing an entirely virtual cognitive self-management program designed to help people with epilepsy manage their condition from home using e-health tools like telephone and computer.

What are the potential side effects?

Since this intervention involves cognitive training and lifestyle management rather than medication, traditional side effects are not expected. However, participants may experience fatigue or stress related to engagement in the program's activities.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have epilepsy, with seizures that may or may not be under control.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have never been diagnosed with epilepsy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ ongoing through entire study baseline - 12 months, and at baseline and at months 3, 6, 9, 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~ongoing through entire study baseline - 12 months, and at baseline and at months 3, 6, 9, 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and ongoing through entire study baseline - 12 months, and at baseline and at months 3, 6, 9, 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in cognitive function

Change in quality of life

Secondary study objectives

Mental Depression

Change in self-management practices

Changes in health confidence

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: HOBSCOTCH-V (virtual)Experimental Treatment1 Intervention

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.

Group II: ControlExperimental Treatment1 Intervention

Participants will be wait listed and will receive HOBSCOTCH-V (above) following a 6 month wait period.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Home Based Self-management and Cognitive Training Changes lives (HOBSCOTCH)

2015

N/A

~110

0 / 2Eligibility criteria met