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Clinical Trials/NCT06145737
NCT06145737
Active, not recruiting
Not Applicable

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

Dartmouth-Hitchcock Medical Center1 site in 1 country11 target enrollmentJanuary 2, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Multiple Sclerosis
Sponsor
Dartmouth-Hitchcock Medical Center
Enrollment
11
Locations
1
Primary Endpoint
Change in subjective cognition as measured by comparing Neuro-QOL Item Bank v2.0 Cognitive Function scores pre- and post-HOBSCOTCH-MS intervention.
Status
Active, not recruiting
Last Updated
5 months ago

Overview

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:

  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
Registry
clinicaltrials.gov
Start Date
January 2, 2024
End Date
January 1, 2028
Last Updated
5 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Elaine T. Kiriakopoulos

Assistant Professor of Neurology, Geisel School of Medicine at Dartmouth Director, HOBSCOTCH Institute for Cognitive Health & Well-Being Dartmouth Hitchcock Epilepsy Center

Dartmouth-Hitchcock Medical Center

Eligibility Criteria

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)

Outcomes

Primary Outcomes

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.

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.

Secondary Outcomes

  • 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 Sites (1)

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