Multiple SclerosisNCT06951919
HOBSCOTCH-MS-Efficacy Trial
A study testing Home Based Self- management and Cognitive Training Changes lives in Multiple Sclerosis (HOBSCOTCH-MS) in people with Multiple Sclerosis and Cognitive Dysfunction, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Multiple Sclerosis, Cognitive Dysfunction, Memory Disorders
- What is being tested?
- Home Based Self- management and Cognitive Training Changes lives in Multiple Sclerosis (HOBSCOTCH-MS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Sep 2025to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- Telephone access
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Dartmouth-Health Lebanon
Lebanon, New Hampshire, 03756
Meredith E Olenec, 6036504225, HOBSCOTCH-MS.Research@Hitchcock.org
Sarah J. Kaden, BA, 6036504225, HOBSCOTCH-MS.Research@Hitchcock.org
About this study
Official title: HOme-Based Self-management and COgnitive Training CHanges Lives (HOBSCOTCH) - Multiple Sclerosis (MS) - Efficacy Trial
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.
Read more
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.
Read the detailed description
The investigators' hypothesis is that the telehealth delivered evidence-based intervention HOBSCOTCH-MS can be delivered by telehealth to improve QOL and neurocognitive function in PwMS. The innovative integration of care partner participation in the proposed coproduced adapted intervention, HOBSCOTCH-MS, will reduce care partner burden and increase care partner knowledge of their loved one's disease and the cognitive challenges they face, leading to an improvement in care partner QOL.
SPECIFIC AIMS: The investigators will test their hypothesis by pursuing the following specific aims:
Aim 1. Evaluate the efficacy of HOBSCOTCH-MS in persons with MS. The investigators' working hypothesis is that treatment will be associated with gains in QOL and subjective cognition in people with multiple sclerosis. The investigators also expect to see improvements in problem-solving ability, objective cognition, knowledge, self-efficacy, and mood. We will examine predictors of response to treatment, including baseline cognition, mood, fatigue, and demographic and disease variables, and mediators including problem-solving abilities and self-efficacy.
Aim 2. Evaluate the efficacy of HOBSCOTCH-MS in care partners (caregivers). The investigators' working hypothesis is that care partners (caregivers) will have improvement in health-related QOL, care partner burden, knowledge, self-efficacy, and mood as a result of their family member with MS participating in the intervention, and by their own participation in education and mindfulness exercises.
Aim 3: Collect and synthesize key informant interview data from a subset of participating people with multiple sclerosis (MS participants) and their Care Partners (Caregiver participants) to inform a future larger scale trial. The investigators' working hypothesis is this qualitative data will assist with refinements to materials and/or program delivery that would recognize and validate key input from people with multiple sclerosis and their care partners (caregivers), allowing the investigators to plan for future large scale research trials and program dissemination.
- Conditions
- Multiple Sclerosis, Cognitive Dysfunction, Memory Disorders, Memory Impairment, Memory Dysfunction
- Being tested
- Home Based Self- management and Cognitive Training Changes lives in Multiple Sclerosis (HOBSCOTCH-MS)
- Keywords
- Cognition, Self-Management, Cognitive Remediation, Cognitive Training, Memory Disorders, Caregivers, Caregiver Burden, Mindfulness
- Medical subject headings
- Multiple Sclerosis, Cognitive Dysfunction, Memory Disorders, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home Based Self- management and Cognitive Training Changes lives in Multiple Sclerosis (HOBSCOTCH-MS)Behavioural
Also called HOBSCOTCH-MS
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 group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: 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. Receives: 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. Receives: Behavioral: Home Based Self- management and Cognitive Training Changes lives in Multiple Sclerosis (HOBSCOTCH-MS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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).
The MS Knowledge Questionnaire is a 12-item Yes/No (true/false) questionnaire that was developed by the study team at the HOBSCOTCH Institute. It is scored based on number of correct responses.
Measured: 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.
The Functional Assessment of Multiple Sclerosis (FAMS) is a validated self-report health-related quality-of-life instrument for people with multiple sclerosis. The FAMS consists of 44 scored (5-point Likert scale) items in six quality-of-life domains: Mobility (seven items), Symptoms (seven items), Emotional wellbeing (seven items), General contentment (seven items), Thinking/fatigue (nine items), and Family/social wellbeing (seven items). An Additional concerns subscale consists of 15 other items that fall outside of the six domains but may provide valuable information to the clinician. The FAMS includes items across the International Classification of Functioning components of body functions, activities and participation, and environmental factors. Higher scores indicate better quality of life.
Measured: 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.
The Symbol Digit Modalities Test (SDMT) is a validated tool that objectively measures cognitive processing speed. It requires a person to substitute a number (1 - 9), either orally or written, for randomized presentations of geometric figures over 90 seconds. Scores range between 0 and 100 with a lower score representing poorer performance.
Measured: 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
The California Verbal Learning Test-III is an objective, validated verbal learning and memory assessment. It consists of a 16-word, list-recall task with up to five learning/recall trials. Higher scores of recall over time are associated with better performance.
Measured: 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
The Brief Visuospatial Memory Test - Revised (BVMT-R) is an objective, standardized assessment to measure visuospatial learning and memory abilities. It consists of six equivalent, alternate BVMT-R stimulus forms of six geometric figures printed in a 2 x 3 array on a separate page of the Recall Stimulus Booklet. In the three Learning Trials, the respondent views the Recall Stimulus page for ten seconds and then is asked to draw as many of the figures as possible in their correct location on a page in the Response Booklet. After a 25-minute delay which includes primarily verbal activities, the task is repeated. Then, the respondent is asked to identify which of the 12 figures in the Recognition Stimulus Booklet were included in the six geometric figures on the original Recall Stimulus page. Higher scores on each of the three trials represent better visuospatial learning and memory.
Measured: Baseline and 3 months post-intervention
Changes 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.
The BRIEF-A is a standardized measure that captures views of an adult's executive functions or self-regulation in his or her everyday environment that includes 75 items within nine scales of executive function. All 75 items are rated in terms of frequency on a 3-point scale: 0 (never), 1 (sometimes), 2 (often). Raw scores for each scale are summed and T scores (M = 50, SD = 10) are used to interpret the individual's level of executive functioning. Higher scores indicate greater impairment in executive functioning.
Measured: 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.
The PROMIS self-efficacy scales is a validated measure designed to assess an individual's confidence in managing various situations, problems and events. 10 items are self-reported on a scale of 1 (I am not at all confident) to 5 (I am very confident). Lower scores indicate poorer perception of self-efficacy.
Measured: Baseline and 3 months post-intervention
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.
The Patient Health Questionnaire (PHQ) is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders. The PHQ-9 is the depression module, which scores each of the 9 DSM-IV criteria on a 4-point Likert scale as "0" (not at all) to "3" (nearly every day). Higher scores are consistent with greater symptoms of poor mood or depression.
Measured: Baseline and 3 months post-intervention
Changes 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.
The Generalized Anxiety Disorder 7 (GAD-7) is a self-reported questionnaire for measuring symptoms of generalized anxiety disorder (GAD). The seven items are scored on a 4-point Likert scale from 0 (not at all) to 3 (nearly every day). Higher scores suggest greater symptoms of anxiety.
Measured: Baseline and 3 months post-intervention
Changes in MS participants' symptom frequency as measured by a daily self-reported diary compared at baseline and at 3 months post-intervention.
MS participants will self-report by checking off any of 10 common MS symptoms using a smartphone app or paper log. The smart phone app was developed by the HOBSCOTH program at Dartmouth-Hitchcock and is used clinically in the HOBSCOTCH program.
Measured: Recorded daily and compared between baseline and 3 months post-intervention
Changes in MS participants' medication adherence as measured by a daily self-reported diary of compared at baseline and at 3 months post-intervention.
MS participants will self-report their medication adherence activity using a smartphone app or paper log checking yes/no to taking medications that day. The smart phone app was developed by the HOBSCOTH program at Dartmouth-Hitchcock and is used clinically in the HOBSCOTCH program.
Measured: Recorded daily and compared between baseline and 3 months post-intervention
Changes in MS participants' use of memory strategies as measured by a daily self-reported diary compared at baseline and 3 months post-intervention.
MS participants will self-report their use of the memory strategies they learn in the HOBSCOTCH-MS program by checking yes/no using a smartphone app developed by the HOBSCOTH program at Dartmouth-Hitchcock or in a paper log.
Measured: Recorded daily and compared between baseline and 3 months post-intervention
Changes in Caregiver participants use of quick relaxation strategies as measured by a daily self-reported diary compared at baseline and 3 months post-intervention.
Caregiver participants will self-report their use of the quick relaxation strategies they learn in the HOBSCOTCH-MS program by checking yes/no using a smartphone app developed by the HOBSCOTH program at Dartmouth-Hitchcock or in a paper log.
Measured: Recorded daily and compared between baseline and 3 months post-intervention
Changes in MS participants and MS Caregiver participants self-reports of wellbeing as measured by comparing daily reports of well-being in a diary at baseline and at 3 months post-intervention.
MS participants and Caregiver participants will self-report daily well-being information throughout the entire study by use of a smartphone app or paper log and a basic 5-item item Likert-scale of well-being ranging from Very Poor to Great.
Measured: Recorded daily and compared between baseline and 3 months post-intervention
Engagement and Satisfaction for MS participants as measured by analyzing study attrition and a Participant Satisfaction Survey at the end of the study.
The Participant Satisfaction Survey has been developed through the original HOBSCOTH program and is used in clinical practice for quality improvement. It contains 10 items scored on a 5-point Likert scale with a higher score indicating greater satisfaction with the program.
Measured: At 6 months (end of study participation)
Engagement and Satisfaction for MS Participants as measured by CollaboRATE post-study completion.
CollaboRATE is a brief, 3 item patient-reported measure of shared decision making, namely the perception of being informed and then involved in decision-making steps. A 10-point anchor scale from 0 (no effort was made) to 9 (every effort was made) with higher scores representing a greater perception of a shared decision-making effort.
Measured: At 6 months (end of study participation).
HOBSCOTCH-MS fidelity as measured by MS participant's compliance with weekly homework assignments.
Homework assignments are given each week in which participants are asked to think about solutions using the Problem Solving Therapy taught in the program. Compliance is measured by Yes (completed homework assignment) or No (did not complete homework assignment).
Measured: Week 1 through Week 8 of HOBSCOTCH-MS intervention.
Changes in MS Caregiver participants self-reported health status as measured by comparing scores on the Short-Form Health Survey 36 (SF-36) at baseline and 3 months-post HOBSCOTCH MS intervention.
The Short Form Health Survey (SF-36) is a validated 36-item, patient- reported survey of patient health. It consists of 8 sub-scales, which are scored on a 3-point, 5-point or dichotomous (yes/no or true/false) scale. The scores are converted to a 1 - 100-point scale with a lower score indicating more disability, i.e. 0 = maximum disability and 100 = no disability.
Measured: Baseline and 3 months post-intervention
Feasibility of HOBSCOTCH-MS program for Caregivers as measured by study attrition and a Participant Satisfaction Survey.
The Participant Satisfaction Survey was developed through the original HOBSCOTH program and is used in clinical practice for quality improvement. It has been modified to address Caregiver's satisfaction as a result or participating in this study and contains 9 items scored on a 5- point Likert scale with a higher score indicating greater satisfaction with the program.
Measured: At 6 months (end of study participation)
Sustainability of improvement on primary outcome measure of quality of life for Group 1 MS Participants by comparing scores on the PROMIS 10-Global Health at 3 months and 6 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.
Measured: 3 months and 6 months post intervention
Sustainability of improvement on primary outcome measure of quality of life for Group 1 MS Participants by comparing scores on the Neuro-QOL at 3 months and 6 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.
Measured: 3 months and 6 months post intervention
Sustainability of improvement on primary outcome measures for Group 1 Caregiver Participants by comparing scores on the Zarit Caregiver Burden at 3 months and 6 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.
Measured: 3 months and 6 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2025
- Study start9 Sep 2025
- Primary completionMay 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elaine T. Kiriakopoulos, Dartmouth-Hitchcock Medical Center
- Investigators
- Elaine T Kiriakopoulos, Principal investigator, Dartmouth-Health/Dartmouth-Hitchcock, Dartmouth College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06951919
- Sponsor's protocol ID
- STUDY02002897
- Status last verified
- Sep 2025
- First submitted
- 23 Apr 2025
- Last updated
- 29 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HOme-Based Self-management and COgnitive Training CHanges Lives (HOBSCOTCH) - Multiple Sclerosis (MS) - Efficacy Trial
- ClinicalTrials.gov ID
- NCT06951919
- Acronym / sponsor ID
- STUDY02002897
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- 9 Sep 2025 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 30 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The investigators' hypothesis is that the telehealth delivered evidence-based intervention HOBSCOTCH-MS can be delivered by telehealth to improve QOL and neurocognitive function in PwMS. The innovative integration of care partner participation in the proposed coproduced adapted intervention, HOBSCOTCH-MS, will reduce care partner burden and increase care partner knowledge of their loved one's disease and the cognitive challenges they face, leading to an improvement in care partner QOL.
SPECIFIC AIMS: The investigators will test their hypothesis by pursuing the following specific aims:
Aim 1. Evaluate the efficacy of HOBSCOTCH-MS in persons with MS. The investigators' working hypothesis is that treatment will be associated with gains in QOL and subjective cognition in people with multiple sclerosis. The investigators also expect to see improvements in problem-solving ability, objective cognition, knowledge, self-efficacy, and mood. We will examine predictors of response to treatment, including baseline cognition, mood, fatigue, and demographic and disease variables, and mediators including problem-solving abilities and self-efficacy.
Aim 2. Evaluate the efficacy of HOBSCOTCH-MS in care partners (caregivers). The investigators' working hypothesis is that care partners (caregivers) will have improvement in health-related QOL, care partner burden, knowledge, self-efficacy, and mood as a result of their family member with MS participating in the intervention, and by their own participation in education and mindfulness exercises.
Aim 3: Collect and synthesize key informant interview data from a subset of participating people with multiple sclerosis (MS participants) and their Care Partners (Caregiver participants) to inform a future larger scale trial. The investigators' working hypothesis is this qualitative data will assist with refinements to materials and/or program delivery that would recognize and validate key input from people with multiple sclerosis and their care partners (caregivers), allowing the investigators to plan for future large scale research trials and program dissemination.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| MS Participant Group 1 | Experimental | Behavioral: Home Based Self- management and Cognitive Training Changes lives in Multiple Sclerosis (HOBSCOTCH-MS)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) |
| MS Participant Group 2 | Active comparator | Behavioral: Home Based Self- management and Cognitive Training Changes lives in Multiple Sclerosis (HOBSCOTCH-MS)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) |
| MS Caregiver Group 1 | Experimental | Behavioral: Home Based Self- management and Cognitive Training Changes lives in Multiple Sclerosis (HOBSCOTCH-MS)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. |
| MS Caregiver Group 2 | Active comparator | Behavioral: Home Based Self- management and Cognitive Training Changes lives in Multiple Sclerosis (HOBSCOTCH-MS)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. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 20 years +
- Fluent in English
- Caregiver to a MS Participant
- Participant MS has given permission to Caregiver to enroll with them
- Internet access
Key exclusion criteria (8 listed)
- Significant visual impairment precluding reading or writing
- No reliable telephone or internet access
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home Based Self- management and Cognitive Training Changes lives in Multiple Sclerosis (HOBSCOTCH-MS)Also: HOBSCOTCH-MSHOBSCOTCH 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. | Behavioural | MS Caregiver Group 1, MS Caregiver Group 2, MS Participant Group 1, MS Participant Group 2 |
Primary outcome
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
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.
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.
Time frame: Baseline and 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.
Change in Caregiver participants caregiver burden as measured by comparing Zarit Burden Interview scores at baseline and at 3 months post-intervention.
Time frame: Baseline and 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.
22 secondary outcomes
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).
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: Baseline and 3 months post-intervention
Changes 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.
Time frame: 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.
Time frame: Baseline and 3 months post-intervention
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.
Time frame: Baseline and 3 months post-intervention
Changes 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.
Time frame: Baseline and 3 months post-intervention
Changes in MS participants' symptom frequency as measured by a daily self-reported diary compared at baseline and at 3 months post-intervention.
Time frame: Recorded daily and compared between baseline and 3 months post-intervention
Changes in MS participants' medication adherence as measured by a daily self-reported diary of compared at baseline and at 3 months post-intervention.
Time frame: Recorded daily and compared between baseline and 3 months post-intervention
Changes in MS participants' use of memory strategies as measured by a daily self-reported diary compared at baseline and 3 months post-intervention.
Time frame: Recorded daily and compared between baseline and 3 months post-intervention
Changes in Caregiver participants use of quick relaxation strategies as measured by a daily self-reported diary compared at baseline and 3 months post-intervention.
Time frame: Recorded daily and compared between baseline and 3 months post-intervention
Changes in MS participants and MS Caregiver participants self-reports of wellbeing as measured by comparing daily reports of well-being in a diary at baseline and at 3 months post-intervention.
Time frame: Recorded daily and compared between baseline and 3 months post-intervention
Engagement and Satisfaction for MS participants as measured by analyzing study attrition and a Participant Satisfaction Survey at the end of the study.
Time frame: At 6 months (end of study participation)
Engagement and Satisfaction for MS Participants as measured by CollaboRATE post-study completion.
Time frame: At 6 months (end of study participation).
HOBSCOTCH-MS fidelity as measured by MS participant's compliance with weekly homework assignments.
Time frame: Week 1 through Week 8 of HOBSCOTCH-MS intervention.
Changes in MS Caregiver participants self-reported health status as measured by comparing scores on the Short-Form Health Survey 36 (SF-36) at baseline and 3 months-post HOBSCOTCH MS intervention.
Time frame: Baseline and 3 months post-intervention
Feasibility of HOBSCOTCH-MS program for Caregivers as measured by study attrition and a Participant Satisfaction Survey.
Time frame: At 6 months (end of study participation)
Sustainability of improvement on primary outcome measure of quality of life for Group 1 MS Participants by comparing scores on the PROMIS 10-Global Health at 3 months and 6 months post-intervention.
Time frame: 3 months and 6 months post intervention
Sustainability of improvement on primary outcome measure of quality of life for Group 1 MS Participants by comparing scores on the Neuro-QOL at 3 months and 6 months post-intervention.
Time frame: 3 months and 6 months post intervention
Sustainability of improvement on primary outcome measures for Group 1 Caregiver Participants by comparing scores on the Zarit Caregiver Burden at 3 months and 6 months post-intervention.
Time frame: 3 months and 6 months post intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elaine T Kiriakopoulos principal investigator
Dartmouth-Health/Dartmouth-Hitchcock, Dartmouth College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home Based Self- management and Cognitive Training Changes lives in Multiple Sclerosis (HOBSCOTCH-MS) in people with Multiple Sclerosis and Cognitive Dysfunction, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Meredith E Olenec (603-650-4225, HOBSCOTCH-MS.Research@Hitchcock.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2025.