Project Summary
PCORI has identified multiple sclerosis (MS) as an important research topic. Patients, clinicians, and others want to learn how different treatment strategies, aimed at changing specific symptoms or the overall course of MS, affect patients’ symptoms and quality of life. To address this issue, PCORI launched a funding initiative in 2015 on Treatment of Multiple Sclerosis. This research project is one of the studies PCORI awarded as part this program.
This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final.
What is the research about?
About 400,000 Americans have multiple sclerosis, or MS. Fatigue is one of the most common and disabling symptoms of MS. Fatigue can keep people from doing a job or hobby or from spending time with family or friends. Fatigue management courses help patients learn skills to manage their fatigue.
In this study, the research team is comparing three ways to deliver a fatigue management course: by teleconference, by internet, and in person. The team is also testing the formats for different groups of people, such as people in racial minority groups and people who live in rural places.
Who can this research help?
Results from this study may help healthcare providers decide how to provide a fatigue management course for patients with MS. Results may also help patients with MS and their doctors choose the best way for the patients to take part in such a course.
What is the research team doing?
The research team is recruiting 610 adults with MS from community organizations and outpatient clinics. The team is assigning adults, by chance, to receive a seven-week course in fatigue management via teleconference or internet or in person (one-on-one). People in the course are learning skills like how to set goals, take rest breaks, and find ways to save energy. An occupational therapist is leading the course in all formats. The research team is comparing how the three formats affect fatigue and quality of life for patients with MS.
Patients with MS, caregivers, neurologists, and occupational therapists are helping to recruit patients and collect data.
Research methods at a glance
| Design Elements | Description |
|---|---|
| Design | Randomized controlled trial |
| Population | Adults 18 years of age and older with MS and a Fatigue Severity scale score ≥4 |
| Interventions/ Comparators |
|
| Outcomes |
Primary: fatigue Secondary: quality of life |
| 6-month follow-up for primary outcome |
COVID-19-Related Study
Summary
Unpaid caregivers, such as family or friends, provide physical and emotional support for patients in the home or remotely. During COVID-19, caregiving can be hard. Caregivers need to protect themselves and those they care for from COVID-19. As a result, caregivers may have mental health problems, such as depression or anxiety, and both patients and caregivers may have worse health outcomes.
With this enhancement, the research team will compare two ways to improve mental health of unpaid caregivers for people with multiple sclerosis:
- A coaching program offered via video with four sessions over six weeks
- A web-only program that caregivers complete on their own
After the study, the research team will share results and make the web-only program available for free.
Enhancement Award Amount: $490,000