Clinical Trials Directory

Trials / Completed

CompletedNCT04639206

A Pragmatic Trial of HOBSCOTCH in Georgia

A Pragmatic Trial of HOme Based Self-management & COgnitive Training CHanges Lives (HOBSCOTCH) in Georgia

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
93 (actual)
Sponsor
Emory University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
BEHAVIORALHOBSCOTCHHOBSCOTCH (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.

Timeline

Start date
2021-03-17
Primary completion
2025-01-10
Completion
2025-01-10
First posted
2020-11-20
Last updated
2025-02-25

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04639206. Inclusion in this directory is not an endorsement.