EpilepsyNCT04639206
A Pragmatic Trial of HOBSCOTCH in Georgia
A study testing HOBSCOTCH in people with Epilepsy, run by Emory University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- HOBSCOTCH
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Mar 2021to 10 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pragmatic Trial of HOme Based Self-management & COgnitive Training CHanges Lives (HOBSCOTCH) in Georgia
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.
Read the 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
- Being tested
- HOBSCOTCH
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HOBSCOTCHBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| HOBSCOTCH group | Experimental | Participants in this study arm will receive the HOBSCOTCH intervention immediately. Receives: Behavioral: HOBSCOTCH |
| Wait-listed control | No intervention | Participants in this study arm will be wait-listed for 6 months and will then receive the HOBSCOTCH intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Quality of Life in Epilepsy (QOLIE-31) Score
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.
Measured: Baseline, Months 3, 6, 9, 12
Change in Neuro Quality of Life (Neuro-QOL) Item Bank v2.0 - Cognitive Function Score
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.
Measured: Baseline, Months 3, 6, 9, 12
Secondary outcomes (7)
Change in Patient Health Questionnaire - 9 Depression (PHQ-9) Score
The PHQ-9 is a 9-item instrument assessing symptoms of depression in the prior two weeks. Responses are given on a 4-point scale where 0 = not at all and 3 = nearly everyday. Total scores range from 0 to 27 where higher scores indicate greater feelings of depression.
Measured: Baseline, Months 3, 6, 9, 12
Change in Adult Epilepsy Self-Management Measurement Instrument (AESMMI-65) Score
The AESMMI-65 is a 65-item instrument assessing 11 domains of self-management of epilepsy. Responses are given on a 5-point scale where 1 = none of the time and 5 = all of the time. Certain items are reverse scored and total scores range from 65 to 325, where higher scores indicate better practice of self-management behaviors.
Measured: Baseline, Months 3, 6, 9, 12
Seizure Frequency
Seizure frequency will be assessed by a self-reported daily log completed either with the mobile application or paper log.
Measured: Baseline to Month 12
Change in Medication Adherence Rating Scale (MARS) Score
The MARS is a 10-item instrument asking about behaviors and attitudes related to medications. Responses of "yes" are scored as 0 and responses of "no" are scored as 1. Total scores range from 0 to 10 where higher scores indicate greater medication adherence.
Measured: Baseline, Months 3, 6, 9, 12
Change in Health Confidence Score (HCS)
Participants are asked four questions assessing their confidence in their own health care. Responses are scored on a 4-point scale where 0 = disagree and 3 = strongly agree. Total scores range from 0 to 12 where higher scores indicate greater confidence regarding health care.
Measured: Baseline, Months 3, 6, 9, 12
Change in Health Care Utilization
Participants will be asked to report their utilization of health care in the prior 6 months.
Measured: Baseline, Months 3, 6, 9, 12
Change in Well-being
Daily well-being will be assessed via the mobile app for a paper log. Participants will rate their well-being as Great, Good, Average, Poor, or Very Poor.
Measured: Baseline to Month12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study start17 Mar 2021
- Primary completion10 Jan 2025
- Study completion10 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Ngoc Cam Escoffery, Emory University
- Investigators
- Cam Escoffery, PhD, MPH, Principal investigator, Emory UniversityKatie Bullinger, MD, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04639206
- Sponsor's protocol ID
- STUDY00000913
- Other IDs
- CDC-STUDY00000913
- Status last verified
- Feb 2025
- First submitted
- 17 Nov 2020
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pragmatic Trial of HOme Based Self-management & COgnitive Training CHanges Lives (HOBSCOTCH) in Georgia
- ClinicalTrials.gov ID
- NCT04639206
- Acronym / sponsor ID
- STUDY00000913
- Conditions
- Epilepsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 17 Mar 2021 (actual)
- Primary completion
- 10 Jan 2025 (actual)
- Study completion
- 10 Jan 2025 (actual)
- First posted
- 20 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HOBSCOTCH group | Experimental | Behavioral: HOBSCOTCHParticipants in this study arm will receive the HOBSCOTCH intervention immediately. |
| Wait-listed control | No intervention | –Participants in this study arm will be wait-listed for 6 months and will then receive the HOBSCOTCH intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HOBSCOTCHHOBSCOTCH (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. | Behavioural | HOBSCOTCH group |
Primary outcome
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.
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.
7 secondary outcomes
Change in Patient Health Questionnaire - 9 Depression (PHQ-9) Score
Time frame: Baseline, Months 3, 6, 9, 12
Change in Adult Epilepsy Self-Management Measurement Instrument (AESMMI-65) Score
Time frame: Baseline, Months 3, 6, 9, 12
Seizure Frequency
Time frame: Baseline to Month 12
Change in Medication Adherence Rating Scale (MARS) Score
Time frame: Baseline, Months 3, 6, 9, 12
Change in Health Confidence Score (HCS)
Time frame: Baseline, Months 3, 6, 9, 12
Change in Health Care Utilization
Time frame: Baseline, Months 3, 6, 9, 12
Change in Well-being
Time frame: Baseline to Month12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cam Escoffery, PhD, MPH principal investigator
Emory University
Katie Bullinger, MD, PhD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HOBSCOTCH in people with Epilepsy, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Quality of Life in Epilepsy (QOLIE-31) Score (time frame: Baseline, Months 3, 6, 9, 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2025.