HOBSCOTCH-MS-Efficacy Trial

NCT06951919 | Recruiting

• 1 other identifier: STUDY02002897
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Sclerosis; Cognitive Dysfunction; Memory Disorders; Memory Impairment; Memory Dysfunction

Keywords

Cognition; Self-Management; Cognitive Remediation; Cognitive Training; Memory Disorders; Caregivers; Caregiver Burden; Mindfulness

Outcome Measures

Primary Outcomes (3)

• 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.

  PROMIS Global-10 Global Health is a validated 10-question survey and part of the Patient-Reported Outcomes Measurement Information System (PROMIS) used to assess health care-related quality of life. Measures include overall health, pain, fatigue, social health, mental health, and physical health. 9 of the items are scored on a Likert Scale of 1 - 5 with 5 representing the best health care-related quality of life; higher scores are associated with better quality of life. One item related to pain is measured on a scale of 1 - 10 with 10 being the worst possible pain.

  Baseline and 3 months post-intervention

• Change in subjective cognitive function in MS participants as measured by comparing scores on the Cognitive Function Sub-Scale (Item Bank 2.0) of the Neuro-QOL at baseline and at 3 months post-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 and 3 months post-intervention

• Change in Caregiver participants caregiver burden as measured by comparing Zarit Burden Interview scores at baseline and at 3 months post-intervention.

  The Zarit Burden Interview is a 22-item questionnaire designed to measure the extent to which a caregiver perceives his or her level of burden as a result of caring for a person with a particular diagnosis. A 5 point Likert scale is used with a higher score indicating a greater level of perceived burden.

  Baseline and 3 months post-intervention

Secondary Outcomes (22)

• Changes in MS and Caregiver participants' knowledge of relationship between the condition of MS and cognition and memory as measured by comparing scores on the HOBSCOTCH-MS Knowledge Questionnaire at baseline and at 6 months (end of study).

  Baseline and at 6 months (end of study)

• Change in MS participants quality of life as measured by comparing FAMS-Functional Assessment of Multiple Sclerosis v4.0 scores at base line and at 3 months post-HOBSCOTCH-MS intervention.

  Baseline and 3 months post-intervention

• Change in MS participants objective cognitive processing speed as measured by comparing Symbol-Digit Modalities Test scores (orally) at base line and at 3 months post-HOBSCOTCH-MS intervention.

  Baseline and 3 months post-intervention

• Change in MS participants verbal learning and memory as measured by comparing California Verbal Learning Test-III scores at baseline and 3 months post-HOBSCOTCH-MS intervention

  Baseline and 3 months post-intervention

• Change in MS participants visuospatial learning and memory as measured by comparting Brief Visuospatial Memory Test-Revised (BVMT-R) scores at baseline and 3 months post-HOBSCOTCH-MS intervention

  Baseline and 3 months post-intervention

Study Arms (4)

MS Participant Group 1

EXPERIMENTAL

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)

Behavioral: Home Based Self- management and Cognitive Training Changes lives in Multiple Sclerosis (HOBSCOTCH-MS)

MS Participant Group 2

ACTIVE COMPARATOR

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)

Behavioral: Home Based Self- management and Cognitive Training Changes lives in Multiple Sclerosis (HOBSCOTCH-MS)

MS Caregiver Group 1

EXPERIMENTAL

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.

Behavioral: Home Based Self- management and Cognitive Training Changes lives in Multiple Sclerosis (HOBSCOTCH-MS)

MS Caregiver Group 2

ACTIVE COMPARATOR

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.

Behavioral: Home Based Self- management and Cognitive Training Changes lives in Multiple Sclerosis (HOBSCOTCH-MS)

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.

Also known as: HOBSCOTCH-MS

MS Caregiver Group 1; MS Caregiver Group 2; MS Participant Group 1; MS Participant Group 2

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 20 - 75 years
• Diagnosis of relapsing or progressive MS
• Education of at least Grade 12 or GED
• Fluent in English
• Subjective cognitive and memory challenges
• Internet access
• Telephone access
• years +
• Fluent in English
• Caregiver to a MS Participant
• Participant MS has given permission to Caregiver to enroll with them
• Internet access
• Telephone access

You may not qualify if:

• Current diagnosed psychiatric disorders (e.g., schizophrenia, bipolar disorder or substance use disorder).
• Other neurological disorder such as epilepsy, brain tumor, severe brain injury or mild to moderate brain injury with a history of 30 or more minutes' loss of consciousness, or other disorder that would confound the focus on MS
• Diagnosed developmental attention, learning, or intellectual disorder; sensory, motor, or physical disability that would prevent engagement with the intervention or render the person unable complete study outcome measures
• Exacerbation of MS symptoms (relapse) or ongoing steroid treatment within three months of study enrollment
• Significant visual impairment precluding reading or writing
• Lack of access to the technical resources (e.g., internet access, telephone) required for participation
• Significant visual impairment precluding reading or writing
• No reliable telephone or internet access

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Dartmouth-Health Lebanon

Lebanon, New Hampshire, 03756, United States

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis; Cognitive Dysfunction; Memory Disorders; Caregiver Burden

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Elaine T Kiriakopoulos

  Dartmouth-Health/Dartmouth-Hitchcock, Dartmouth College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Meredith E Olenec

CONTACT

603-650-4225; HOBSCOTCH-MS.Research@Hitchcock.org

Sarah J Kaden

CONTACT

603-650-4225; HOBSCOTCH-MS.Research@Hitchcock.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Elaine T. Kiriakopoulos, MD, MPH, MSc Assistant Professor of Neurology, Geisel School of Medicine at Dartmouth Director, HOBSCOTCH Institute for Cognitive Health & Well-Being Dartmouth Hitchcock Epilepsy Center

Study Record Dates

• First Submitted: April 23, 2025
• First Posted: April 30, 2025
• Study Start: September 9, 2025
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: October 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)