HOBSCOTCH-MS-Efficacy Trial
Status
Conditions
Treatments
Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
125 participants in 4 patient groups
Trial contacts and locations
Loading...
Central trial contact
Sarah J. Kaden
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal