HOme-Based Self-management and COgnitive Training CHanges Lives (HOBSCOTCH) - Multiple Sclerosis (MS)

NCT06145737 | Active Not Recruiting

• 1 other identifier: STUDY02002107
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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:

• 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

Keywords

Multiple Sclerosis; Memory Disorders; Cognition; Self-Management

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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.

  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.

  Baseline (pre-HOBSCOTCH-MS) and post-HOBSCOTCH-MS, approximately 9 weeks later.

Study Arms (1)

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)

Behavioral: HOme-Based Self-management and COgnitive Training CHanges lives (HOBSCOTCH)

Interventions

HOme-Based Self-management and COgnitive Training CHanges lives (HOBSCOTCH) BEHAVIORAL

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.

Also known as: HOBSCOTCH-MS

MS Participant with Cognitive Dysfunction

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Dartmouth-Hitchcock

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis; Cognitive Dysfunction; Memory Disorders

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Elaine T Kiriakopoulos, MD, MPH, MSc

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

• Heather A Wishart, PhD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Neurology, Geisel School of Medicine at Dartmouth Director, HOBSCOTCH Institute for Cognitive Health & Well-Being Dartmouth Hitchcock Epilepsy Center

Study Record Dates

• First Submitted: November 17, 2023
• First Posted: November 24, 2023
• Study Start: January 2, 2024
• Primary Completion: November 1, 2025
• Study Completion (Estimated): January 1, 2028
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)