RECRUITING

HOBSCOTCH-MS-Efficacy Trial

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Conditions

Multiple SclerosisCognitive DysfunctionMemory DisordersMemory ImpairmentMemory DysfunctionCognitionSelf-ManagementCognitive RemediationCognitive TrainingCaregiversCaregiver BurdenMindfulness

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-09-09
Study Completion:2028-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06951919

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:20 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Inclusion Criteria - MS Participant
  2. * Age 20 - 75 years
  3. * Diagnosis of relapsing or progressive MS
  4. * Education of at least Grade 12 or GED
  5. * Fluent in English
  6. * Subjective cognitive and memory challenges
  7. * Internet access
  8. * Telephone access
  9. * 20 years +
  10. * Fluent in English
  11. * Caregiver to a MS Participant
  12. * Participant MS has given permission to Caregiver to enroll with them
  13. * Internet access
  14. * Telephone access
  1. * Exclusion Criteria MS Participant
  2. * Current diagnosed psychiatric disorders (e.g., schizophrenia, bipolar disorder or substance use disorder).
  3. * 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
  4. * 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
  5. * Exacerbation of MS symptoms (relapse) or ongoing steroid treatment within three months of study enrollment
  6. * Significant visual impairment precluding reading or writing
  7. * Lack of access to the technical resources (e.g., internet access, telephone) required for participation
  8. * Significant visual impairment precluding reading or writing
  9. * No reliable telephone or internet access

Contacts and Locations

Study Contact

Meredith E Olenec
CONTACT
603-650-4225
HOBSCOTCH-MS.Research@Hitchcock.org
Sarah J Kaden
CONTACT
603-650-4225
HOBSCOTCH-MS.Research@Hitchcock.org

Principal Investigator

Elaine T Kiriakopoulos
PRINCIPAL_INVESTIGATOR
Dartmouth-Health/Dartmouth-Hitchcock, Dartmouth College

Study Locations (Sites)

Dartmouth-Health Lebanon
Lebanon, New Hampshire, 03756
United States

Collaborators and Investigators

Sponsor: Dartmouth-Hitchcock Medical Center

  • Elaine T Kiriakopoulos, PRINCIPAL_INVESTIGATOR, Dartmouth-Health/Dartmouth-Hitchcock, Dartmouth College

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-09-09
Study Completion Date2028-12

Study Record Updates

Study Start Date2025-09-09
Study Completion Date2028-12

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

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