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

Multiple Sclerosis Clinical Trial

— HOBSCOTCH-MS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06145737
• Other study ID #: STUDY02002107
• Status: Recruiting
• Phase: N/A
• Start date: January 2, 2024
• Est. completion date: February 1, 2025

Study information

• Verified date: February 2024
• Source: Dartmouth-Hitchcock Medical Center
• Contact: Sarah J Kaden, BA
• Phone: 603-650-4225
• Email: sarah.j.kaden[@]hitchcock.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: February 1, 2025
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Memory Disorders
• Multiple Sclerosis
• Sclerosis

Intervention

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

Locations

Country	Name	City	State
United States	Dartmouth-Hitchcock	Lebanon	New Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	Change in objective cognition as measured by comparing Symbol-Digit Modalities Test scores pre- and post-HOBSCOTCH-MS intervention.	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.	Baseline (pre-HOBSCOTCH-MS) and post-HOBSCOTCH-MS, approximately 9 weeks later.
Secondary	Change in objective cognition as measured by comparing California Verbal Learning Test-III scores pre- and post-HOBSCOTCH-MS intervention.	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.	Baseline (pre-HOBSCOTCH-MS) and post-HOBSCOTCH-MS, approximately 9 weeks later.