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NCT Number: NCT06145737

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

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. 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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Cognition Disorders Cognitive Dysfunction Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Memory Disorders Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dartmouth-Hitchcock

Lebanon, New Hampshire, 03756, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

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.

Other names: HOBSCOTCH-MS

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

    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.

  2. 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.

    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.

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Registry information

Acronym: HOBSCOTCH-MS

Important dates

Study start
2024
Primary completion
2025
Study completion
2028
First posted
Nov 24, 2023
Registry last updated
Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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