Clinical trial NCT06145737: HOme-Based Self-management and COgnitive Training CHanges Lives (HOBSCOTCH) - Multiple Sclerosis (MS)
Official title: HOme-Based Self-management and COgnitive Training CHanges Lives (HOBSCOTCH) - Multiple Sclerosis (MS)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Cognitive Dysfunction
Memory Disorders
Keywords: Multiple Sclerosis
Memory Disorders
Cognition
Self-Management
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2023-11-24
Enrollment: 11
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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


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)

Primary outcomes:
measure: Change in quality of life as measured by comparing FAMS-Functional Assessment of Multiple Sclerosis v4.0 scores pre- and post-HOBSCOTCH-MS intervention.
timeFrame: Baseline (pre-HOBSCOTCH-MS) and post-HOBSCOTCH-MS, approximately 9 weeks later.
measure: Change in subjective cognition as measured by comparing Neuro-QOL Item Bank v2.0 Cognitive Function scores pre- and post-HOBSCOTCH-MS intervention.
timeFrame: Baseline (pre-HOBSCOTCH-MS) and post-HOBSCOTCH-MS, approximately 9 weeks later.
Secondary outcomes:
measure: Change in objective cognition as measured by comparing Symbol-Digit Modalities Test scores pre- and post-HOBSCOTCH-MS intervention.
timeFrame: Baseline (pre-HOBSCOTCH-MS) and post-HOBSCOTCH-MS, approximately 9 weeks later.
measure: Change in objective cognition as measured by comparing California Verbal Learning Test-III scores pre- and post-HOBSCOTCH-MS intervention.
timeFrame: Baseline (pre-HOBSCOTCH-MS) and post-HOBSCOTCH-MS, approximately 9 weeks later.
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Elaine T Kiriakopoulos, MD, MPH, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Dartmouth-Hitchcock Medical Center
name: Heather A Wishart, PhD
role: PRINCIPAL_INVESTIGATOR
References: