- Three projects to test mHealth and telehealth platforms in the treatment of multiple sclerosis are slated to get more than $14 million in grant funding from the Patient-Centered Outcomes Research Institute (PCORI).
The studies are part of a five-program, $38 million effort by the Washington DC-based independent non-profit to tackle a progressive – and unpredictable – neurological disease that affects some 400,000 Americans and 2.3 million globally and costs millions of dollars annually in the US for treatment.
The University of Michigan will be receiving $3.5 million for a project that will use a wrist-borne sensor to measure the effects of two different treatments for fatigue: cognitive behavioral therapy (CBT) delivered by phone and the wakefulness-promoting drug modafinil.
“[P]roviders have little information to help them decide whether a single therapy, such as a medication or behavioral therapy, will be enough for a given patient, or whether therapies should be combined to provide the best results,” the program’s two principal investigators, Tiffany Braley, MD, MS, and Anna Kratz, PhD, said in the study summary.
“Fatigue will be measured with a combination of patient-centered survey measures as well as measures of physical activity and fatigue, which will be collected with a wrist-worn device as study participants go about their day,” they said. “These measures will open a window into the day-to-day experiences of patients with MS, before and after treatment.”
The project will also study the effects of depression, sleep disturbances and disability and patient fatigue, as well as treatment adherence and side effects.
“Results of this study will help patients, providers, and policy makers determine which patients with fatigue respond best to cognitive behavioral therapy or modafinil, and which MS patients may benefit most from a combination of these treatments,” Braley and Kratz said.
Another fatigue study is being launched by researchers at Case Western Reserve University.
That project is getting $4.9 million to test the effectiveness of three different forms of fatigue management: in-person instruction during medical visits, online instructions and the telehealth platform featuring video visits.
“Research indicates that a fatigue self-management course called Managing Fatigue is effective in reducing the impact of fatigue in a variety of different delivery formats,” principal investigator Matthew A. Plow, PhD, said in his summary. “Participants in the course learn about taking rest breaks, re-evaluating priorities, communicating needs, re-organizing spaces and experimenting with strategies for ‘banking’ energy and ‘spending’ limited energy to meet personal, meaningful goals.”
Plow said the two telehealth modes would be comparable to the in-person mode, the goal being to prove that telehealth would be easier for MS patients than in-person therapy.
“Results from this proposal could be used as rationale to deliver telerehabilitation versions of the Managing Fatigue course to people who typically cannot access these courses due to geographic barriers,” Plow said. “Furthermore, people with MS will be able to confidently conclude that they can participate in telerehabilitation formats to reduce the impact of fatigue.”
The third project, for which PCORI has set aside $5.7 million, will be conducted by Atlanta’s Shepherd Center and compare traditional exercise therapies at a gym or rehab center with a telerehabilitation therapy available to patients at home.
“Symptoms of MS, as well as inaccessible gyms or equipment, lack of knowledge about how to safely exercise with MS, lack of understanding about the types of exercise that would be beneficial to people with MS, and affordability are some factors that make it harder for people with MS to exercise, even if they are highly motivated,” principal investigators Deborah A. Backus, PhD, PT, and Robert Motl, PhD, MS, said in their summary.
“Providing evidence about different delivery modes of an exercise program will help people with MS make educated decisions about how to best use their time and resources to improve their mobility, decrease their disability, and maintain a healthy and productive life,” they added. “In addition, this information could be used by medical, rehabilitation, and exercise professionals in developing accessible programs for people with MS.”
PCORI has invested $64 million to date on a dozen programs targeting MS, including one that led to the development of iConquerMS, a patient-powered research network within PCORnet. In all, the organization has doled out almost $2 billion in funding since its 2012 launch to more than 600 clinical effectiveness research (CER) studies.
They’re not the only ones using mHealth to study MS.
Just last month, Novartis announced a new study on Apple’s ResearchKit platform designed to connect with MS patients across the country through an mHealth app on their iPhones.
The elevateMS (Evaluation of Evidence from Smart Phone Sensors and Patient-Reported Outcomes in Participants with Multiple Sclerosis) study, using mHealth technology developed by Sage Bionetworks, “aims to improve understanding of the daily challenges patients with MS can have and to uncover new potential measurements of treatment effectiveness through real-time data collection from participants in their everyday life.”
PCORI, meanwhile, has funded several programs to test the functionality of mHealth and telehealth platforms.
In 2016, the State University of New York received a $7 million grant to test the value of telemedicine in treating patients with the hepatitis C virus at a dozen methadone clinics around the state. The five-year project is comparing a standard regimen of in-person care with treatment by video visits.
Also in 2016, PCORI issued a $1.5 million grant to New Jersey-based Northwell Health’s Feinstein Institute for Medical Research to study whether a telemedicine platform can help Hispanic patients diagnosed with COPD access care and treatment at home.