A Pragmatic Trial of HOme Based Self-management & COgnitive Training CHanges Lives (HOBSCOTCH) in Georgia
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Epilepsy
- Sponsor
- Emory University
- Enrollment
- 93
- Locations
- 1
- Primary Endpoint
- Change in Neuro Quality of Life (Neuro-QOL) Item Bank v2.0 - Cognitive Function Score
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Ngoc Cam Escoffery
Professor
Emory University
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
- •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
Outcomes
Primary Outcomes
Change in Neuro Quality of Life (Neuro-QOL) Item Bank v2.0 - Cognitive Function Score
Time Frame: Baseline, Months 3, 6, 9, 12
Efficacy of the HOBSCOTCH intervention will be assessed with the Neuro-QOL instrument.The Neuro-QOL - Cognitive Function questionnaire includes 28 items asking about how much difficulty they are experiencing and how often they have had trouble with certain tasks during the past 7 days. Responses are given on a scale from 1 to 5 where 1 = cannot do/very often and 5 = none/never. Total scores range from 28 to 140 and higher scores indicate improved cognitive function.
Change in Quality of Life in Epilepsy (QOLIE-31) Score
Time Frame: Baseline, Months 3, 6, 9, 12
Efficacy of the HOBSCOTCH intervention will be assessed with the QOLIE-31 instrument. The QOLIE includes 31 questions about health and daily activities. Responses are given on a range of scales. Responses are coded to 0 to 100 point scales where higher scores indicate better quality of life. The final score is the average of scores for the individual items. Final scores can be converted to a T-score with a mean of 50 and standard deviation of 10, where higher T-scores indicate better quality of life.
Secondary Outcomes
- Seizure Frequency(Baseline to Month 12)
- Change in Well-being(Baseline to Month12)
- Change in Adult Epilepsy Self-Management Measurement Instrument (AESMMI-65) Score(Baseline, Months 3, 6, 9, 12)
- Change in Patient Health Questionnaire - 9 Depression (PHQ-9) Score(Baseline, Months 3, 6, 9, 12)
- Change in Medication Adherence Rating Scale (MARS) Score(Baseline, Months 3, 6, 9, 12)
- Change in Health Confidence Score (HCS)(Baseline, Months 3, 6, 9, 12)
- Change in Health Care Utilization(Baseline, Months 3, 6, 9, 12)