A Pragmatic Trial of HOBSCOTCH in Georgia

NCT ID: NCT04639206

Last Updated: 2025-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 93 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-17
• Study Completion Date: 2025-01-10

Brief Summary

This study is being done to answer the question: Will a home-based self-management program, HOBSCOTCH, be effective in improving quality of life and perceived difficulties in cognitive abilities by teaching problem-solving strategies? The research team is also looking at a new mobile application that was developed to go with the program, and looking at extra booster sessions to improve long-term outcomes.

In order to learn about the effectiveness of the program, half of the people in this study will be randomly assigned to be in the intervention immediately. The other half will be randomly assigned to a 6-month waitlist period before getting the intervention. All participants will receive the program at some point during the study.

Detailed Description

Epilepsy affects 3.4 million people in the U.S. who suffer from many problems including seizures and medication side effects, and depression and memory problems. Epilepsy self-management programs have been proven to improve the lives of people with epilepsy (PWE). For over 10 years, the Managing Epilepsy Well (MEW) Network has developed and researched several epilepsy self-management programs with promising results. One such program is HOBSCOTCH (HOme-Based Self-management and COgnitive Training CHanges lives), which addresses memory problems and has shown improved thought processes, or cognition, in randomized control trials.

HOBSCOTCH has been tested and re-tested in the New England region with promising results in improving quality of life and cognitive functioning, or improved thought processes. To make the program more widely available, HOBSCOTCH will be offered in the state of Georgia, where the population is different compared to the New England region.

This study plans to enroll a total of 150 adults with epilepsy to participate in the program in two cycles of roughly 50-75 people. Of the 50-75 participants to enroll in the program, 25-37 participants will be assigned to the intervention group, and the other 25-37 participants will be assigned to the waitlist group. Participants will take part in the program that will last eight sessions. A trained and certified HOBSCOTCH memory coach will deliver one-on-one sessions with participants on a weekly basis and each session will last between 45-60 minutes. The first session and the last session will be done in-person or through video chat. All participants will be given standard testing at baseline, 3, 6, 9, and 12 months. The testing will help in understanding if the program helps improve memory problems and if the HOBSCOTCH program should continue to be offered to people with epilepsy.

Conditions

Epilepsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

HOBSCOTCH group

Participants in this study arm will receive the HOBSCOTCH intervention immediately.

Group Type: EXPERIMENTAL

HOBSCOTCH

Intervention Type: BEHAVIORAL

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. The HOBSCOTCH intervention consists of 8 weekly sessions conducted in-person, over the telephone, or via video-conferencing. A smart phone application will be used to collect data on seizure frequency, medication adherence, and patient engagement.

Wait-listed control

Participants in this study arm will be wait-listed for 6 months and will then receive the HOBSCOTCH intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

HOBSCOTCH

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. The HOBSCOTCH intervention consists of 8 weekly sessions conducted in-person, over the telephone, or via video-conferencing. A smart phone application will be used to collect data on seizure frequency, medication adherence, and patient engagement.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Diagnosis of epilepsy (self-reported by participant), 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 electroencephalogram (EEG) evaluation is acceptable
• Literate
• Telephone access
• Internet access

Exclusion Criteria

• Participants self-reporting a dementing illness or a dementing illness appearing in their medical record.
• Severe mental disability or estimated intelligence quotient (IQ) less than 70 per clinical judgement
• Significant visual impairment precluding reading or writing
• No reliable telephone or internet access
• No diagnosis of epilepsy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centers for Disease Control and Prevention

FED

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Ngoc Cam Escoffery

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cam Escoffery, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Emory University

Katie Bullinger, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory Brain Health Center

Atlanta, Georgia, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

CDC-STUDY00000913

Identifier Type: OTHER

Identifier Source: secondary_id

STUDY00000913

Identifier Type: -

Identifier Source: org_study_id