HOBSCOTCH Program for Epilepsy

Overseen By Suzanne B Lenz, MA, CCRC

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dartmouth-Hitchcock Medical Center

Disqualifiers: Dementia, Severe mental disability, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 11

Duration: 7 weeks

140 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must not have changed your antiepileptic or antidepressant medications in the past month.

What data supports the effectiveness of the HOBSCOTCH treatment for epilepsy?

Research shows that the HOBSCOTCH program, which includes self-management and cognitive training, helps improve memory and problem-solving skills in people with epilepsy, leading to a better quality of life. ^{1 2 3 4 5}

Is the HOBSCOTCH program safe for humans?

The available research on the HOBSCOTCH program for epilepsy does not report any safety concerns, suggesting it is generally safe for humans. ^{2 3 6 7 8}

How is the HOBSCOTCH treatment for epilepsy different from other treatments?

HOBSCOTCH is unique because it focuses on teaching people with epilepsy self-management and cognitive strategies to improve their quality of life, rather than relying on medication. It is a home-based program that helps individuals develop problem-solving and memory skills, which can enhance their ability to manage the condition. ^{1 2 3 4 9}

What is the purpose of this trial?

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).

Research Team

Barbara Jobst, MD

Principal Investigator

Dartmouth-Hitchcock Medical Center and Dartmouth College

Eligibility Criteria

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.

Inclusion Criteria

You need to have access to the internet.

Literate

I have access to a telephone.

Exclusion Criteria

No reliable telephone or internet access

Severe mental disability or estimated IQ less than 70 per clinical judgement

Subjects self-reporting a dementing illness or a mention of a dementing illness in their medical record

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-HOBSCOTCH Session

Participants receive a pre-HOBSCOTCH session via webcam to prepare for the intervention

1 week

1 visit (virtual)

Educational Session

Participants receive an educational session via webcam

1 week

1 visit (virtual)

Treatment

Participants receive the HOBSCOTCH intervention consisting of 6 telephone sessions and 1 wrap-up session

7 weeks

6 visits (telephone), 1 visit (virtual or telephone)

Booster Sessions

Participants receive 3 booster sessions via webcam or telephone, once per month

3 months

3 visits (virtual or telephone)

Follow-up

Participants are monitored for changes in self-management practices, healthcare utilization, depression, medication adherence, seizure frequency, health confidence, overall well-being, quality of life, and cognitive function

12 months

Treatment Details

Interventions

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

Trial Overview 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.

Participant Groups

Group I: HOBSCOTCH-V (virtual) Experimental Treatment 1 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: Control Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Dartmouth-Hitchcock Medical Center

Lead Sponsor

Trials

548

Recruited

2,545,000+

Centers for Disease Control and Prevention

Collaborator

Trials

902

Recruited

25,020,000+

Findings from Research

The SMART self-management program significantly reduced negative health events (NHEs) in adults with epilepsy, showing an odds ratio of 3.2 compared to a wait-list group, based on a 6-month randomized controlled trial with 120 participants.

Improvements in self-management, quality of life, and reductions in depression symptoms were found to mediate about 20-30% of the program's effectiveness in reducing NHEs, highlighting the importance of addressing mental health and quality of life in epilepsy care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a remotely delivered group-format epilepsy self-management program on adverse health outcomes in vulnerable people with epilepsy: A causal mediation analysis. Briggs, FBS., Wilson, BK., Pyatka, N., et al.[2021]

The SMART intervention significantly reduced the number of negative health events (NHEs) in adults with epilepsy over a 6-month period compared to a waitlist control group, indicating its efficacy in managing health complications related to epilepsy.

Participants in the SMART program also experienced improvements in mood, quality of life, and overall health functioning, as measured by various scales, although there was no change in seizure severity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A 6-month prospective randomized controlled trial of remotely delivered group format epilepsy self-management versus waitlist control for high-risk people with epilepsy. Sajatovic, M., Colon-Zimmermann, K., Kahriman, M., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Understanding the self-management skills of persons with epilepsy. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Self-rated executive dysfunction in adults with epilepsy and effects of a cognitive-behavioral intervention (HOBSCOTCH). [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of a Self-Management Program to Improve Cognition and Quality of Life in Epilepsy: A Pragmatic, Randomized, Multicenter Trial. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Process evaluation of a multi-component self-management intervention for adults with epilepsy (ZMILE study). [2019]

5. England pubmed.ncbi.nlm.nih.gov

Feasibility of a pediatric cognitive-behavioral self-management intervention: Coping Openly and Personally with Epilepsy (COPE). [2018]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Effects of a remotely delivered group-format epilepsy self-management program on adverse health outcomes in vulnerable people with epilepsy: A causal mediation analysis. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

A 6-month prospective randomized controlled trial of remotely delivered group format epilepsy self-management versus waitlist control for high-risk people with epilepsy. [2019]

8. Germany pubmed.ncbi.nlm.nih.gov

Self-management practices associated with quality of life for adults with epilepsy. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

MEW network self-management program characteristics and lessons learned through the RE-AIM framework. [2023]