Clinical trial NCT04639206: A Pragmatic Trial of HOBSCOTCH in Georgia
Official title: A Pragmatic Trial of HOme Based Self-management & COgnitive Training CHanges Lives (HOBSCOTCH) in Georgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epilepsy
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2020-11-20
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change in Quality of Life in Epilepsy (QOLIE-31) Score
timeFrame: Baseline, Months 3, 6, 9, 12
measure: Change in Neuro Quality of Life (Neuro-QOL) Item Bank v2.0 - Cognitive Function Score
timeFrame: Baseline, Months 3, 6, 9, 12
Secondary outcomes:
measure: Change in Patient Health Questionnaire - 9 Depression (PHQ-9) Score
timeFrame: Baseline, Months 3, 6, 9, 12
measure: Change in Adult Epilepsy Self-Management Measurement Instrument (AESMMI-65) Score
timeFrame: Baseline, Months 3, 6, 9, 12
measure: Seizure Frequency
timeFrame: Baseline to Month 12
measure: Change in Medication Adherence Rating Scale (MARS) Score
timeFrame: Baseline, Months 3, 6, 9, 12
measure: Change in Health Confidence Score (HCS)
timeFrame: Baseline, Months 3, 6, 9, 12
measure: Change in Health Care Utilization
timeFrame: Baseline, Months 3, 6, 9, 12
measure: Change in Well-being
timeFrame: Baseline to Month12
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory Brain Health Center
state: Georgia
Study officials:
affiliation: Emory University
name: Cam Escoffery, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: Katie Bullinger, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: