HOBSCOTCH-MS for Multiple Sclerosis

Overseen By Sarah J Kaden

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dartmouth-Hitchcock Medical Center

Disqualifiers: Psychiatric disorders, Neurological disorders, Visual impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

125 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a home-based program called HOBSCOTCH-MS can enhance the quality of life and cognitive function for people with multiple sclerosis (MS), particularly those with memory issues. Participants will engage in weekly virtual sessions with a coach to learn skills such as problem-solving and relaxation, and they will complete short assignments and surveys. The trial also examines the program's impact on caregivers of people with MS, though joining with a caregiver is optional. This may suit individuals with MS who face cognitive and memory challenges and have internet access. As an unphased trial, this study provides a unique opportunity to explore innovative support methods for improving daily life with MS.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on cognitive and memory interventions rather than medication changes.

What prior data suggests that the HOBSCOTCH-MS program is safe for individuals with multiple sclerosis?

Research has shown that the HOBSCOTCH-MS program helps people with multiple sclerosis manage thinking and memory issues from home. It includes online coaching sessions that teach problem-solving and relaxation techniques. Past participants found the program easy to handle, as it involves no medical procedures or drugs.

Studies of similar programs have not reported any major side effects. Since this program focuses on behavior rather than medication, the risks are much lower compared to drug treatments. Participants learn skills that can improve everyday life without safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about HOBSCOTCH-MS for multiple sclerosis because it offers a unique approach to managing the condition through home-based cognitive and self-management training. Unlike traditional MS treatments, which often focus on medication and physical therapy, HOBSCOTCH-MS emphasizes personalized, one-on-one sessions that can be conducted via webcam or phone, making it highly accessible. This method not only aims to improve cognitive function and self-management skills but also incorporates caregiver involvement, which can enhance support and outcomes for patients. Additionally, the program's flexibility and focus on both patients and caregivers could lead to comprehensive improvements in quality of life for those living with MS.

What evidence suggests that the HOBSCOTCH-MS program is effective for improving quality of life and cognitive function in multiple sclerosis?

Research shows that the HOBSCOTCH-MS program can assist people with multiple sclerosis (MS) who experience memory and thinking issues. In this trial, MS Participant Group 1 will receive the HOBSCOTCH-MS intervention immediately, while MS Participant Group 2 will receive it after a 3-month wait. Studies have found that this program teaches effective strategies for handling everyday challenges related to MS. Participants in similar programs have reported enhanced problem-solving skills and improved management of cognitive symptoms. The program's emphasis on relaxation and mindfulness reduces stress, aiding in the management of MS symptoms. Early findings suggest these improvements can also lessen the burden on caregivers, enhancing their quality of life. Caregiver Group 1 will participate alongside their MS participant immediately, while Caregiver Group 2 will join after a 3-month wait. ^{2 3 4 5 6}

Who Is on the Research Team?

Elaine T Kiriakopoulos

Principal Investigator

Dartmouth-Health/Dartmouth-Hitchcock, Dartmouth College

Are You a Good Fit for This Trial?

This trial is for individuals aged 20-75 with relapsing or progressive multiple sclerosis who have completed at least a Grade 12 education level. Participants must have internet and telephone access, speak English fluently, and experience cognitive and memory challenges. Caregivers can also join but it's optional.

Inclusion Criteria

My condition is relapsing or progressive MS.

I have multiple sclerosis.

I am between 20 and 75 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Intervention

Participants complete a pre-HOBSCOTCH session and an educational session via webcam

1 week

2 visits (virtual)

Intervention

Participants receive HOBSCOTCH-MS intervention with weekly sessions including problem-solving therapy and mindfulness training

8 weeks

8 visits (6 telephone, 2 virtual)

Follow-up

Participants are monitored for changes in quality of life and cognitive function

3 months

2 visits (virtual)

Optional Key Informant Interview

Participants may participate in a one-time interview for qualitative analysis

What Are the Treatments Tested in This Trial?

Interventions

• Home Based Self-Management and Cognitive Training Changes lives in Multiple Sclerosis (HOBSCOTCH-MS)

Trial Overview The HOBSCOTCH-MS program is being tested to see if it improves life quality and cognitive function in people with MS. It includes virtual sessions on problem-solving therapy and mindfulness, homework assignments, daily diary entries via an app, plus questionnaires over a six-month period.

How Is the Trial Designed?

Group I: MS Participant Group 1 Experimental Treatment 1 Intervention

MS Participant Group 1 will receive the HOBSCOTCH-MS 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)

Group II: MS Caregiver Group 1 Experimental Treatment 1 Intervention

Caregiver Group 1 will receive an adapted version of HOBSCOTCH-MS by attending the introductory session and session 1 of the HOBSCOTCH-MS (virtual) program with their MS participant as well as guidance and instructions on utilizing quick relaxation. Caregiver Group 1 will also attend session 8 of the program with the MS patient to focus on program wrap-up and maintenance planning.

Group III: MS Participant Group 2 Active Control 1 Intervention

MS Participant Group 2 will be on a 3-month wait list after which they will receive HOBSCOTCH-MS 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)

Group IV: MS Caregiver Group 2 Active Control 1 Intervention

Caregiver Group 2 will be on a 3 month wait list with their MS participant after which time they will receive an adapted version of HOBSCOTCH-MS by attending the introductory session and session 1 of the HOBSCOTCH-MS (virtual) program with their MS patient as well as guidance and instructions on utilizing quick relaxation. Caregiver Group 1 will also attend session 8 of the program with the MS patient to focus on program wrap-up and maintenance planning.

Who Is Running the Clinical Trial?

Dartmouth-Hitchcock Medical Center

Lead Sponsor

Trials

548

Recruited

2,545,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06145737?term=AREA%5BBasicSearch%5D(ms%20as)&rank=9

HOme-Based Self-management and COgnitive Training ... This type of expanded access is used when multiple patients with the same disease or condition seek access to a specific drug or biological product that has not ...

2. dartmouth-hitchcock.org dartmouth-hitchcock.org/hobscotch-institute/hobscotch-ms-program

HOme-Based Self-Management and COgnitive Training ... The HOBSCOTCH-MS program teaches people how MS and cognitive problems can be related, and how to find strategies and solutions to better manage the day-to-day ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06951919

Study Details | NCT06951919 | HOBSCOTCH-MS-Efficacy ... The purpose of this study is to assess the ability of the home-based intervention, HOBSCOTCH-MS to improve the quality of life and cognitive function in ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06145737/home-based-self-management-and-cognitive-training-changes-lives-hobscotch-multiple-sclerosis-ms

HOme-Based Self-management and COgnitive Training ... The goal of this pilot study is to assess the feasibility of adapting and delivering the existing home-based epilepsy self-management ...

5. withpower.com withpower.com/trial/phase-multiple-sclerosis-11-2023-ed4b9

Home-Based Cognitive Training for Multiple Sclerosis · Info ... What data supports the effectiveness of the treatment HOme-Based Self-management and COgnitive Training CHanges Lives (HOBSCOTCH) for multiple sclerosis?

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06145737

HOme-Based Self-management and COgnitive Training ... One on one virtual self-management program for cognitive dysfunction associated with Multiple Sclerosis (MS). HOBSCOTCH is a home-based self-management program ...