HOBSCOTCH-MS-Efficacy Trial

Part of paid clinical trials in Lebanon, New Hampshire.

Sponsor
Dartmouth-Hitchcock Medical Center
Study ID
NCT06951919
Status
Recruiting
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Conditions

  • Cognitive Dysfunction
  • Memory Disorders
  • Memory Dysfunction
  • Memory Impairment
  • Multiple Sclerosis

Eligibility Criteria

Sex
ALL
Age
20 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Home Based Self- management and Cognitive Training Changes lives in Multiple Sclerosis (HOBSCOTCH-MS) — BEHAVIORAL
    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 specifically for people who have multiple sclerosis. It incorporates education about these conditions and cognition into the education module.

Study Details

The purpose of this study is to assess the ability of the home-based intervention, HOBSCOTCH-MS to improve the quality of life and cognitive function in Service Members, Veterans and civilians who have multiple sclerosis with cognitive and memory problems (MS participants). This study will also assess the ability of the HOBSCOTCH-MS program to improve quality of life in caregivers of patients with multiple sclerosis and to reduce caregiver burden. Enrolling with a Caregiver is optional for MS participants. Investigators will compare two groups of MS participants and their Caregiver (enrolling with a Caregiver is optional): one who receives HOBSCOTCH-MS immediately (Group 1) and another group that will receive HOBSCOTCH-MS (Group 2) after a 3-month waiting period. Participants will be in the study for about 6 months total. HOBSCOTCH-MS involves 45 to 60 minute one on one virtual sessions with a certified Cognitive Coach including a "pre" program session and 8 weekly sessions thereafter. Participants will learn about problem solving therapy and mindfulness or relaxation training. MS participants are asked to do short homework assignments and both MS and Caregiver participants are asked to keep a brief daily diary on a smart phone app. All participants complete study questionnaires or surveys at enrollment, 3 months later and at 6 months (at the end of the study). After completing the intervention, MS Participants and their Caregivers may also participate in an optional one-time Key Informant Interview for qualitative analysis in an effort to further adapt and improve the HOBSCOTCH-MS in the future.

Key Dates

Start date
Sep 9, 2025
Status verified
Sep 2025
Primary completion
May 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
125 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: MS Participant Group 1
    MS Participant Group 1 will receive the HOBSCOTCH-MS intervention consisting of 1:1 sessions delivered once per week including: * 1 pre-HOBSCOTCH * Session (on webcam) * 1 educational session (on webcam) * 6 telephone sessions * 1 wrap-up session (webcam or telephone)
  • Active Comparator: MS Participant Group 2
    MS Participant Group 2 will be on a 3-month wait list after which they will receive HOBSCOTCH-MS consisting of 1:1 sessions delivered once per week including: * 1 pre-HOBSCOTCH * Session (on webcam) * 1 educational session (on webcam) * 6 telephone sessions * 1 wrap-up session (webcam or telephone)
  • Experimental: MS Caregiver Group 1
    Caregiver Group 1 will receive an adapted version of HOBSCOTCH-MS by attending the introductory session and session 1 of the HOBSCOTCH-MS (virtual) program with their MS participant as well as guidance and instructions on utilizing quick relaxation. Caregiver Group 1 will also attend session 8 of the program with the MS patient to focus on program wrap-up and maintenance planning.
  • Active Comparator: MS Caregiver Group 2
    Caregiver Group 2 will be on a 3 month wait list with their MS participant after which time they will receive an adapted version of HOBSCOTCH-MS by attending the introductory session and session 1 of the HOBSCOTCH-MS (virtual) program with their MS patient as well as guidance and instructions on utilizing quick relaxation. Caregiver Group 1 will also attend session 8 of the program with the MS patient to focus on program wrap-up and maintenance planning.

Primary Outcome Measure

Change in quality of life in MS participants as measured by comparing PROMIS-10 Global Health scores at baseline and at 3 months post-intervention. [ Time Frame: Baseline and 3 months post-intervention ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Dartmouth-Health LebanonLebanonNew Hampshire03756
Meredith E Olenec
[email protected]
6036504225
Sarah J. Kaden, BA
[email protected]
6036504225
Elaine T. Kirikapoulos, MD, MPH, MSc (PRINCIPAL_INVESTIGATOR)

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