EpilepsyNCT04519775
HOBSCOTCH Phase III
A study testing Home Based Self-management and Cognitive Training Changes lives (HOBSCOTCH) in people with Epilepsy, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to determine the efficacy of an entirely virtual version of the home-based cognitive self-management program "HOBSCOTCH." It will test whether HOBSCOTCH can be delivered nationally from a distance utilizing e-health tools (telephone, computer, and phone). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- Home Based Self-management and Cognitive Training Changes lives (HOBSCOTCH)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Nov 2020to 19 Nov 2024
- 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
- Age 18+
- Diagnosis of epilepsy, 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 EEG evaluation is acceptable
- Literate
- Telephone access
- Internet access
Who cannot join
- Subjects self-reporting a dementing illness or a mention of a dementing illness in their medical record
- Severe mental disability or estimated 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.
United States1 site
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
About this study
Official title: HOBSCOTCH Phase III: Efficacy of Enhanced Virtual HOBSCOTCH
The purpose of this study is to determine the efficacy of an entirely virtual version of the home-based cognitive self-management program "HOBSCOTCH." It will test whether HOBSCOTCH can be delivered nationally from a distance utilizing e-health tools (telephone, computer, and phone).
Read the detailed description
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.
HOBSCOTCH Phase III is a study to examine an entirely virtual version of the program. While HOBSCOTCH was shown to be effective as an in-person and telephone-based program in previous trials (HOBSCOTCH Phase I and II), this study aims to test a version of the program adapted for entirely virtual delivery. This is a single-center study, with the HOBSCOTCH intervention being delivered by staff affiliated with Dartmouth-Hitchcock Medical Center in Lebanon, NH.
- Conditions
- Epilepsy
- Being tested
- Home Based Self-management and Cognitive Training Changes lives (HOBSCOTCH)
- Keywords
- Epilepsy Memory Problems, Self-Management
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home Based Self-management and Cognitive Training Changes lives (HOBSCOTCH)Behavioural
Also called HOBSCOTCH
HOBSCOTCH 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.
| Study group | Role | What they receive |
|---|---|---|
| HOBSCOTCH-V (virtual) | Experimental | Participants will receive the HOBSCOTCH intervention consisting of 1:1 sessions delivered once per week, including:
* 1 pre-HOBSCOTCH Session (on webcam)
* 1 educational session (on webcam)
* 6 telephone sessions
* 1 wrap-up session (webcam or telephone)
Participants will also receive 3 booster sessions, via webcam or telephone, once per month. Receives: Behavioral: Home Based Self-management and Cognitive Training Changes lives (HOBSCOTCH) |
| Control | Other | Participants will be wait listed and will receive HOBSCOTCH-V (above) following a 6 month wait period. Receives: Behavioral: Home Based Self-management and Cognitive Training Changes lives (HOBSCOTCH) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in quality of life
The researchers will use the Quality of Life in Epilepsy (QOLIE-31). This validated tool contains 16 multi-item scales which assess health related quality of life, emotional well-being, memory and attention deficits, medication effects, seizure control, psychosocial functioning, and health perception. Scores range from 0 to 100, with a higher score reflecting a higher quality of life.
Measured: Baseline and at months 3, 6, 9, 12
Change in cognitive function
The researchers will use the Cognitive Function sub-scale of the NeuroQOL. This is a brief validated tool developed by the NIH for use in patients with neurological disease. Scores range from 8 to 40, with a higher score indicating better reported cognitive functioning.
Measured: Baseline and at months 3, 6, 9, 12
Secondary outcomes (7)
Change in depression
The researchers will use the Patient Health Questionnaire (PHQ-9). The PHQ-9 is a brief 9-item validated depression scale. Scores range from 0 to 27. Scores of 5, 10, 15, and 20 represent cut-offs for mild, moderate, moderately severe, and severe depression, respectively.
Measured: Baseline and at months 3, 6, 9, 12
Change in self-management practices
The researchers will use the Adult Epilepsy Self-Management Measurement Instrument (AESMMI-65).This is a 65 item scale that assesses use of epilepsy self-management practices. Scores range from 65 to 325, with a higher score indicating more frequent use of self-management strategies.
Measured: Baseline and at months 3, 6, 9, 12
Changes in self-reported seizure frequency
The researchers will collect seizure information throughout the entire study by use of a smartphone app or paper log to track seizures daily. No range.
Measured: Ongoing through entire study baseline - 12 months
Changes in medication adherence
Medication adherence will be collected using the Medication Adherence Rating Scale (MARS), a 10-item inventory to measure medication adherence, as well as by a daily single item medication adherence question through a smartphone app or paper log. For the MARS, scores range from 0 to 10, with a higher score indicating better adherence.
Measured: Ongoing through entire study baseline - 12 months, and at baseline and at months 3, 6, 9, 12
Changes in health confidence
The researchers will use the Health Confidence Score, a 4-item measure of health confidence. Scores range from 0 to 13, with a higher score indicating better health confidence.
Measured: Baseline and at months 3, 6, 9, 12
Changes in healthcare utilization
The researchers will use the Health Care Utilization 4-item measure from the Self-Management Resource Center to capture utilization of health services in the last 6 months. No range.
Measured: Baseline and at months 3, 6, 9, 12
Changes in overall well-being
The researchers will collect daily well-being information throughout the entire study by use of a smartphone app or paper log and a basic single item Likert-scale of well-being. No range.
Measured: Ongoing through entire study baseline - 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2020
- Study start12 Nov 2020
- Primary completion26 Sep 2024
- Study completion19 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- 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
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Barbara Jobst, Dartmouth-Hitchcock Medical Center
- Investigators
- Barbara Jobst, MD, Principal investigator, Dartmouth-Hitchcock Medical Center and Dartmouth College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04519775
- Sponsor's protocol ID
- D12217 Phase III
- Status last verified
- Jun 2025
- First submitted
- 17 Aug 2020
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Caller TA, Secore KL, Ferguson RJ, Roth RM, Alexandre FP, Henegan PL, Harrington JJ, Jobst BC. Design and feasibility of a memory intervention with focus on self-management for cognitive impairment in epilepsy. Epilepsy Behav. 2015 Mar;44:192-4. doi: 10.1016/j.yebeh.2014.12.036. Epub 2015 Feb 27.
PubMed 25731132Caller TA, Ferguson RJ, Roth RM, Secore KL, Alexandre FP, Zhao W, Tosteson TD, Henegan PL, Birney K, Jobst BC. A cognitive behavioral intervention (HOBSCOTCH) improves quality of life and attention in epilepsy. Epilepsy Behav. 2016 Apr;57(Pt A):111-117. doi: 10.1016/j.yebeh.2016.01.024. Epub 2016 Mar 2.
PubMed 26943948
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HOBSCOTCH Phase III: Efficacy of Enhanced Virtual HOBSCOTCH
- ClinicalTrials.gov ID
- NCT04519775
- Acronym / sponsor ID
- D12217 Phase III
- Conditions
- Epilepsy
- Keywords
- Epilepsy Memory Problems, Self-Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 12 Nov 2020 (actual)
- Primary completion
- 26 Sep 2024 (actual)
- Study completion
- 19 Nov 2024 (actual)
- First posted
- 20 Aug 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.
The purpose of this study is to determine the efficacy of an entirely virtual version of the home-based cognitive self-management program "HOBSCOTCH." It will test whether HOBSCOTCH can be delivered nationally from a distance utilizing e-health tools (telephone, computer, and phone).
Detailed description
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.
HOBSCOTCH Phase III is a study to examine an entirely virtual version of the program. While HOBSCOTCH was shown to be effective as an in-person and telephone-based program in previous trials (HOBSCOTCH Phase I and II), this study aims to test a version of the program adapted for entirely virtual delivery. This is a single-center study, with the HOBSCOTCH intervention being delivered by staff affiliated with Dartmouth-Hitchcock Medical Center in Lebanon, NH.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HOBSCOTCH-V (virtual) | Experimental | Behavioral: Home Based Self-management and Cognitive Training Changes lives (HOBSCOTCH)Participants will receive the HOBSCOTCH intervention consisting of 1:1 sessions delivered once per week, including: * 1 pre-HOBSCOTCH Session (on webcam) * 1 educational session (on webcam) * 6 telephone sessions * 1 wrap-up session (webcam or telephone) Participants will also receive 3 booster sessions, via webcam or telephone, once per month. |
| Control | Other | Behavioral: Home Based Self-management and Cognitive Training Changes lives (HOBSCOTCH)Participants will be wait listed and will receive HOBSCOTCH-V (above) following a 6 month wait period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18+
- Diagnosis of epilepsy, 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 EEG evaluation is acceptable
- Literate
Key exclusion criteria (5 listed)
- Subjects self-reporting a dementing illness or a mention of a dementing illness in their medical record
- Severe mental disability or estimated 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 |
|---|---|---|
| Home Based Self-management and Cognitive Training Changes lives (HOBSCOTCH)Also: HOBSCOTCHHOBSCOTCH 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. | Behavioural | Control, HOBSCOTCH-V (virtual) |
Primary outcome
Change in quality of life
Time frame: Baseline and at months 3, 6, 9, 12
The researchers will use the Quality of Life in Epilepsy (QOLIE-31). This validated tool contains 16 multi-item scales which assess health related quality of life, emotional well-being, memory and attention deficits, medication effects, seizure control, psychosocial functioning, and health perception. Scores range from 0 to 100, with a higher score reflecting a higher quality of life.
Change in cognitive function
Time frame: Baseline and at months 3, 6, 9, 12
The researchers will use the Cognitive Function sub-scale of the NeuroQOL. This is a brief validated tool developed by the NIH for use in patients with neurological disease. Scores range from 8 to 40, with a higher score indicating better reported cognitive functioning.
7 secondary outcomes
Change in depression
Time frame: Baseline and at months 3, 6, 9, 12
Change in self-management practices
Time frame: Baseline and at months 3, 6, 9, 12
Changes in self-reported seizure frequency
Time frame: Ongoing through entire study baseline - 12 months
Changes in medication adherence
Time frame: Ongoing through entire study baseline - 12 months, and at baseline and at months 3, 6, 9, 12
Changes in health confidence
Time frame: Baseline and at months 3, 6, 9, 12
Changes in healthcare utilization
Time frame: Baseline and at months 3, 6, 9, 12
Changes in overall well-being
Time frame: Ongoing through entire study baseline - 12 months
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 1 Jul 2025.
- Background: PubMed 25731132Caller TA, Secore KL, Ferguson RJ, Roth RM, Alexandre FP, Henegan PL, Harrington JJ, Jobst BC. Design and feasibility of a memory intervention with focus on self-management for cognitive impairment in epilepsy. Epilepsy Behav. 2015 Mar;44:192-4. doi: 10.1016/j.yebeh.2014.12.036. Epub 2015 Feb 27.
- Background: PubMed 26943948Caller TA, Ferguson RJ, Roth RM, Secore KL, Alexandre FP, Zhao W, Tosteson TD, Henegan PL, Birney K, Jobst BC. A cognitive behavioral intervention (HOBSCOTCH) improves quality of life and attention in epilepsy. Epilepsy Behav. 2016 Apr;57(Pt A):111-117. doi: 10.1016/j.yebeh.2016.01.024. Epub 2016 Mar 2.
- 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.
Barbara Jobst, MD principal investigator
Dartmouth-Hitchcock Medical Center and Dartmouth College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home Based Self-management and Cognitive Training Changes lives (HOBSCOTCH) in people with Epilepsy, run by Dartmouth-Hitchcock Medical Center 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 7 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 1 Jul 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 (time frame: Baseline and at 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?
On the ClinicalTrials.gov record for NCT04519775, which also lists 2 linked publications.
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 1 Jul 2025.