Newswise — A new clinical trial will explore three interventions in improving one of the most disabling symptoms for people with multiple sclerosis: fatigue.
The Patient-Centered Outcomes Research Institute has approved a $3,476,448 funding award over four years to Michigan Medicine’s Tiffany Braley, M.D., M.S. and Anna Kratz, Ph.D.
“This clinical trial will use a patient-centered approach that takes into account the many facets of MS, in order to directly impact clinical practice and payer coverage of two of the most widely accepted treatments for MS fatigue,” says Braley, assistant professor of neurology.
Three interventions
The researchers say a lack of evidence to help patients and other stakeholders choose from the available care options makes this topic important to explore.
Braley and Kratz’s team will compare the effectiveness of:
- Modafinil, a commonly used fatigue medication
- Cognitive behavioral therapy, a commonly used behavioral treatment strategy
- A combination of both treatments
All subjects will wear accelerometers to measure their physical activity, and they’ll self-report their fatigue severity and fatigability throughout the day. The investigators say the cognitive behavioral therapy will be administered by phone to address treatment accessibility. Collaborators have a variety of specialties, including neurology, physical medicine and rehabilitation, psychology and psychiatry.
“The interdisciplinary nature of this study team is very exciting, particularly because it matches the common real-world scenario where patients seek out a variety of different practitioners for help in managing difficult symptoms like fatigue,” says Kratz, assistant professor of physical medicine and rehabilitation.
This contract is one of 11 just announced by the PCORI to improve care for a range of health conditions, and one of five studies funded to address various aspects of MS treatment.
“This project was selected for PCORI funding for its potential to fill an important gap in our understanding of MS treatment. It will provide useful information to help patients and their caregivers weigh the effectiveness of their care options,” said PCORI Executive Director Joe Selby, M.D., MPH. “We look forward to following the study’s progress and working with Michigan Medicine to share the results.”
Both principal investigators are members of U-M’s Institute for Healthcare Policy & Innovation, which will help the team disseminate study findings to clinicians and health policy stakeholders based on the results.
Additional investigators from the University of Michigan include: Ronald Chervin, M.D., M.S., Benjamin Segal, M.D., Roderick Little, Ph.D. and Deirdre Conroy, Ph.D.
The multi-site study also includes collaboration with Dawn Ehde, Ph.D., Kevin Alschuler, Ph.D. and Gloria von Geldern, M.D., at the University of Washington Medicine Multiple Sclerosis Center.
Throughout the study, investigators will work closely with key stakeholders, including MS patients, community groups, payers and MS providers and clinical staff, including Jeanie Cote, M.D., Kathy Bennett, R.N. and Kim Duval, CMAS Lead Sr.
This award has been approved pending completion of a business and programmatic review by PCORI staff and issuance of a formal award contract.
PCORI is an independent, nonprofit organization authorized by Congress in 2010. Its mission is to fund research that will provide patients, their caregivers, and clinicians with the evidence-based information needed to make better-informed healthcare decisions.