HOme-Based Self-management and COgnitive Training CHanges Lives (HOBSCOTCH) - Multiple Sclerosis (MS)
- Conditions
- Multiple SclerosisCognitive DysfunctionMemory Disorders
- Interventions
- Behavioral: HOme-Based Self-management and COgnitive Training CHanges lives (HOBSCOTCH)
- Registration Number
- NCT06145737
- Lead Sponsor
- Dartmouth-Hitchcock Medical Center
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 11
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description MS Participant with Cognitive Dysfunction 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)
- Primary Outcome Measures
Name Time Method Change in subjective cognition as measured by comparing Neuro-QOL Item Bank v2.0 Cognitive Function scores pre- and post-HOBSCOTCH-MS intervention. 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. 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 Outcome Measures
Name Time Method 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. 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.
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. 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.
Trial Locations
- Locations (1)
Dartmouth-Hitchcock
🇺🇸Lebanon, New Hampshire, United States