Multiple SclerosisHOBSCOTCH-MSNCT06145737
HOme-Based Self-management and COgnitive Training CHanges Lives (HOBSCOTCH) - Multiple Sclerosis (MS)
A study testing HOme-Based Self-management and COgnitive Training CHanges lives (HOBSCOTCH) in people with Multiple Sclerosis and Cognitive Dysfunction, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
The goal of this pilot study is to assess the feasibility of adapting and delivering the existing home-based epilepsy self-management intervention, HOBSCOTCH, for people with multiple sclerosis (MS). The main questions it aims to answer are: 1. Can the current HOBSCOTCH program be adapted for people with MS? 2. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Multiple Sclerosis, Cognitive Dysfunction, Memory Disorders
- 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
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jan 2024to 1 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 20 - 65 years
- Literate, English-speaking with grade 12 or equivalent in education
- Self-reported diagnosis of MS
- Self-reported cognitive/memory difficulties
- Telephone and internet access
Who cannot join
- Cognitive dysfunction that precludes participation in giving informed consent
- Significant visual impairment precluding reading or writing
- No reliable telephone or internet access
- Acute psychiatric illness
- History of progressive neurodegenerative disease (dementia)
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this pilot study is to assess the feasibility of adapting and delivering the existing home-based epilepsy self-management intervention, HOBSCOTCH, for people with multiple sclerosis (MS).
The main questions it aims to answer are:
Read more
- Can the current HOBSCOTCH program be adapted for people with MS?
- Will people with MS experience improved quality of life similar to that found in people with epilepsy after participating in the HOBSCOTCH program?
Participants will be asked to:
- attend nine, one-hour virtual (online and/or by telephone) HOBSCOTCH-MS sessions with a one-on-one certified HOBSCOTCH-MS coach
- complete a brief clinical questionnaire about their diagnosis of MS
- complete four questionnaires before and after the HOBSCOTCH-MS sessions about their quality of life and about memory and thinking processes
- keep a short daily diary about their MS symptoms and use of the self-management strategies taught in the HOBSCOTCH-MS program
- complete a brief Satisfaction Survey after the entire HOBSCOTCH-MS program
- Conditions
- Multiple Sclerosis, Cognitive Dysfunction, Memory Disorders
- Being tested
- HOme-Based Self-management and COgnitive Training CHanges lives (HOBSCOTCH)
- Keywords
- Multiple Sclerosis, Memory Disorders, Cognition, Self-Management
- Medical subject headings
- Multiple Sclerosis, Cognitive Dysfunction, Memory Disorders
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-MS
One on one virtual self-management program for cognitive dysfunction associated with Multiple Sclerosis (MS).
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. HOBSCOTCH-MS is an adaptation of the HOBSCOTCH program for people with MS and incorporates education about multiple sclerosis and cognition into the education module.
| Study group | Role | What they receive |
|---|---|---|
| MS Participant with Cognitive Dysfunction | Other | Participants will receive the HOBSCOTCH-MS intervention consisting of 1:1 sessions delivered once per week including:
* 1 pre-HOBSCOTCH Session (on webcam or by phone)
* 1 educational session (on webcam)
* 6 HOBSCOTCH intervention sessions (webcam or phone)
* 1 wrap-up session (webcam or phone) 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 as measured by comparing FAMS-Functional Assessment of Multiple Sclerosis v4.0 scores pre- and post-HOBSCOTCH-MS intervention.
The Functional Assessment of Multiple Sclerosis (FAMS) is a validated self-report health-related quality-of-life instrument for people with multiple sclerosis. The FAMS consists of 44 scored (5-point Likert scale) items in six quality-of-life domains: Mobility (seven items), Symptoms (seven items), Emotional wellbeing (seven items), General contentment (seven items), Thinking/fatigue (nine items), and Family/social wellbeing (seven items). An Additional concerns subscale consists of 15 other items that fall outside of the six domains but may provide valuable information to the clinician. The FAMS includes items across the International Classification of Functioning components of body functions, activities and participation, and environmental factors. Higher scores indicate better quality of life.
Measured: Baseline (pre-HOBSCOTCH-MS) and post-HOBSCOTCH-MS, approximately 9 weeks later.
Change in subjective cognition as measured by comparing Neuro-QOL Item Bank v2.0 Cognitive Function scores pre- and post-HOBSCOTCH-MS intervention.
The Cognitive Function sub-scale of the Neuro-QOL 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 (pre-HOBSCOTCH-MS) and post-HOBSCOTCH-MS, approximately 9 weeks later.
Secondary outcomes (2)
Change in objective cognition as measured by comparing Symbol-Digit Modalities Test scores pre- and post-HOBSCOTCH-MS intervention.
The Symbol Digit Modalities Test (SDMT) is a validated tool that measures cognitive processing speed. It requires a person to substitute a number (1 - 9), either orally or written, for randomized presentations of geometric figures over 90 seconds. Scores range between 0 and 100 with a lower score representing poorer performance.
Measured: Baseline (pre-HOBSCOTCH-MS) and post-HOBSCOTCH-MS, approximately 9 weeks later.
Change in objective cognition as measured by comparing California Verbal Learning Test-III scores pre- and post-HOBSCOTCH-MS intervention.
The California Verbal Learning Test-III is a validated verbal learning and memory assessment. It consists of a 16-word, list-recall task with up to five learning/recall trials. Higher scores of recall over time are associated with better performance.
Measured: Baseline (pre-HOBSCOTCH-MS) and post-HOBSCOTCH-MS, approximately 9 weeks later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2023
- Study start2 Jan 2024
- Primary completion1 Nov 2025
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elaine T. Kiriakopoulos, Dartmouth-Hitchcock Medical Center
- Investigators
- Elaine T Kiriakopoulos, MD, MPH, MSc, Principal investigator, Dartmouth-Hitchcock Medical CenterHeather A Wishart, PhD, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06145737
- Sponsor's protocol ID
- STUDY02002107
- Acronym
- HOBSCOTCH-MS
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2023
- Last updated
- 21 Nov 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 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HOme-Based Self-management and COgnitive Training CHanges Lives (HOBSCOTCH) - Multiple Sclerosis (MS)
- ClinicalTrials.gov ID
- NCT06145737
- Acronym / sponsor ID
- HOBSCOTCH-MS / STUDY02002107
- Conditions
- Multiple Sclerosis, Cognitive Dysfunction, Memory Disorders
- Keywords
- Multiple Sclerosis, Memory Disorders, Cognition, Self-Management
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- 2 Jan 2024 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 24 Nov 2023 (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 goal of this pilot study is to assess the feasibility of adapting and delivering the existing home-based epilepsy self-management intervention, HOBSCOTCH, for people with multiple sclerosis (MS).
The main questions it aims to answer are:
- Can the current HOBSCOTCH program be adapted for people with MS?
- Will people with MS experience improved quality of life similar to that found in people with epilepsy after participating in the HOBSCOTCH program?
Participants will be asked to:
- attend nine, one-hour virtual (online and/or by telephone) HOBSCOTCH-MS sessions with a one-on-one certified HOBSCOTCH-MS coach
- complete a brief clinical questionnaire about their diagnosis of MS
- complete four questionnaires before and after the HOBSCOTCH-MS sessions about their quality of life and about memory and thinking processes
- keep a short daily diary about their MS symptoms and use of the self-management strategies taught in the HOBSCOTCH-MS program
- complete a brief Satisfaction Survey after the entire HOBSCOTCH-MS program
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MS Participant with Cognitive Dysfunction | Other | Behavioral: HOme-Based Self-management and COgnitive Training CHanges lives (HOBSCOTCH)Participants will receive the HOBSCOTCH-MS intervention consisting of 1:1 sessions delivered once per week including: * 1 pre-HOBSCOTCH Session (on webcam or by phone) * 1 educational session (on webcam) * 6 HOBSCOTCH intervention sessions (webcam or phone) * 1 wrap-up session (webcam or phone) |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 20 - 65 years
- Literate, English-speaking with grade 12 or equivalent in education
- Self-reported diagnosis of MS
- Self-reported cognitive/memory difficulties
- Telephone and internet access
Key exclusion criteria (5 listed)
- Cognitive dysfunction that precludes participation in giving informed consent
- Significant visual impairment precluding reading or writing
- No reliable telephone or internet access
- Acute psychiatric illness
- History of progressive neurodegenerative disease (dementia)
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: HOBSCOTCH-MSOne on one virtual self-management program for cognitive dysfunction associated with Multiple Sclerosis (MS). 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. HOBSCOTCH-MS is an adaptation of the HOBSCOTCH program for people with MS and incorporates education about multiple sclerosis and cognition into the education module. | Behavioural | MS Participant with Cognitive Dysfunction |
Primary outcome
Change in quality of life as measured by comparing FAMS-Functional Assessment of Multiple Sclerosis v4.0 scores pre- and post-HOBSCOTCH-MS intervention.
Time frame: Baseline (pre-HOBSCOTCH-MS) and post-HOBSCOTCH-MS, approximately 9 weeks later.
The Functional Assessment of Multiple Sclerosis (FAMS) is a validated self-report health-related quality-of-life instrument for people with multiple sclerosis. The FAMS consists of 44 scored (5-point Likert scale) items in six quality-of-life domains: Mobility (seven items), Symptoms (seven items), Emotional wellbeing (seven items), General contentment (seven items), Thinking/fatigue (nine items), and Family/social wellbeing (seven items). An Additional concerns subscale consists of 15 other items that fall outside of the six domains but may provide valuable information to the clinician. The FAMS includes items across the International Classification of Functioning components of body functions, activities and participation, and environmental factors. Higher scores indicate better quality of life.
Change in subjective cognition as measured by comparing Neuro-QOL Item Bank v2.0 Cognitive Function scores pre- and post-HOBSCOTCH-MS intervention.
Time frame: Baseline (pre-HOBSCOTCH-MS) and post-HOBSCOTCH-MS, approximately 9 weeks later.
The Cognitive Function sub-scale of the Neuro-QOL 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.
2 secondary outcomes
Change in objective cognition as measured by comparing Symbol-Digit Modalities Test scores pre- and post-HOBSCOTCH-MS intervention.
Time frame: Baseline (pre-HOBSCOTCH-MS) and post-HOBSCOTCH-MS, approximately 9 weeks later.
Change in objective cognition as measured by comparing California Verbal Learning Test-III scores pre- and post-HOBSCOTCH-MS intervention.
Time frame: Baseline (pre-HOBSCOTCH-MS) and post-HOBSCOTCH-MS, approximately 9 weeks later.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 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.
Elaine T Kiriakopoulos, MD, MPH, MSc principal investigator
Dartmouth-Hitchcock Medical Center
Heather A Wishart, PhD principal investigator
Dartmouth-Hitchcock Medical Center
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 Multiple Sclerosis and Cognitive Dysfunction, 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 5 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: under way, not looking for participants, as of the sponsor's last update on 21 Nov 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?
This study is still under way. Results are not available in the source record yet.
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 as measured by comparing FAMS-Functional Assessment of Multiple Sclerosis v4.0 scores pre- and post-HOBSCOTCH-MS intervention. (time frame: Baseline (pre-HOBSCOTCH-MS) and post-HOBSCOTCH-MS, approximately 9 weeks later.). 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 21 Nov 2025.