HOBSCOTCH-MS-Efficacy Trial
What it found
No result yet.
What was tested
Treatment tested
- Home Based Self- management and Cognitive Training Changes lives in Multiple Sclerosis (HOBSCOTCH-MS)
What it measured
Main measures
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.
Baseline and 3 months post-intervention
FatiguePainQuality of life (reported by participants)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.
Baseline and 3 months post-intervention
Thinking and memoryQuality of life (reported by participants)Change in Caregiver participants caregiver burden as measured by comparing Zarit Burden Interview scores at baseline and at 3 months post-intervention.
Baseline and 3 months post-intervention
Other measures (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)
Thinking and memoryChange 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
FatigueWalking and mobilityQuality of life (reported by participants)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
Thinking and memoryChange 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
Thinking and memoryChange 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
Thinking and memoryChanges in MS participants executive function as measured by comparing scores on the self-reported Behavior Inventory of Executive Function-Adult Version (BRIEF-A) at baseline and 3-months post intervention.
Baseline and 3 months post-intervention
Changes in MS participants self-efficacy as measured by comparing scores on the PROMIS (Patient-Reported Outcomes Measurement Information System) Item Bank v1.0 General Self-Efficacy assessment at baseline and 3-months post-intervention.
Baseline and 3 months post-intervention
Quality of life (reported by participants)Changes in MS participants and Caregiver participants mood as measured by comparing scores on the Patient Health Questionnaire (PHQ-9) at baseline and at 3 months post- intervention.
Baseline and 3 months post-intervention
Mood and sleepChanges in MS participants and Caregiver participants anxiety as measured by comparing score on the Generalized Anxiety Disorder-7 (GAD-7) at baseline and at 3-months post-intervention.
Baseline and 3 months post-intervention
Mood and sleepChanges in MS participants' symptom frequency as measured by a daily self-reported diary compared at baseline and at 3 months post-intervention.
Recorded daily and compared between baseline and 3 months post-intervention
Who could take part
Progressive MS · 20 to 75
Inclusion Criteria: * Inclusion Criteria - MS Participant * 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 Inclusion Criteria - Caregiver Participant * 20 years + * Fluent in English * Caregiver to a MS Participant * Participant MS has given permission to Caregiver to enroll with them * Internet access * Telephone access Exclusion Criteria: * Exclusion Criteria MS Participant * 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 Exclusion Criteria - Caregiver Participant * Significant visual impairment precluding reading or writing * No reliable telephone or internet access
As registered. Criteria can change, so ask the trial team or your neurologist.
Contact details on the registryAbout this trial
In the sponsor's words
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.
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History
Started
Sept 2025
Main results due
May 2028
Finished
Dec 2028
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