Traveling to a clinic or hospital to participate in a clinical trial can be challenging for people who have limited mobility or can't drive because of a neurologic condition such as multiple sclerosis (MS) or epilepsy.
But what if the trial made a house call? The concept of conducting trials in participants' homes is gaining traction, thanks to new technology and tests that enable researchers to monitor symptoms and interventions remotely.
Not only do these types of trials benefit patients and caregivers, they also help scientists gather better data. They allow researchers to get more people involved, including those with more severe disease, says Lauren Strober, PhD, a research scientist at the Kessler Foundation. A larger and more diverse group means researchers can draw better conclusions about whether and how well an intervention works, she says.
As patients look for ways to improve their quality of life, researchers are responding with studies designed to test interventions meant to be practiced at home. “What we hear from patients is that they are interested in trials focused on physical activity, diet, exercise, and so on,” says Nicholas G. LaRocca, PhD, vice president for health care delivery and policy research at the National MS Society.
When participants can follow the program at home, there's also a much greater chance they'll stick with it—and continue to reap its benefits—once the trial period ends, says Dr. LaRocca. “Being able to fulfill the steps of the protocol in their own home, in their own environment, means it's more likely that they'll incorporate it into their regular routine after the study is over.”
That's the goal of the New Jersey and Illinois-based PHYSACTINMS (Physical Activity in MS; http://bit.ly/PHYSACTINMS) trial, which uses a weight-training program to improve strength and mobility in people with relapsing-remitting MS. Participants first meet with a physical trainer for four sessions to learn the exercises and adjust the amount of weight they're using. Then they practice the exercises on their own for three months, with equipment provided by the researchers, says Dr. Strober, one of the investigators. Researchers check in with the participants three times by phone during the trial period at weeks six, 10, and 12 to make sure everything is going smoothly, “and then we see them in the clinic at the final visit,” she says.
HOW TECH HELPS
Smartphones and tablets equipped with high-speed Internet connections make it much easier for researchers to collect real-time data and monitor patients' symptoms and activity levels remotely. In the ongoing Connect.Parkinson study (http://bit.ly/ConnectParkinson), for example, researchers are connecting nearly 200 people with Parkinson's disease with doctors remotely, using computers and tablets equipped with cameras and video conferencing software. (For those who don't have the required technology or software, the researchers supply it.)
The investigators want to know if the concept is feasible and if it improves patients' quality of care, says lead investigator E. Ray Dorsey, MD, MBA, a professor of neurology and co-director of the Center for Human Experimental Therapeutics at the University of Rochester Medical Center. They'll also evaluate how these virtual visits might reduce travel time and caregiving burdens.
The trial is about halfway complete, and while patients say they appreciate the convenience, some doctors say they prefer to have a first visit with a patient in person, “so that they've formed a relationship” before making virtual house calls, says Dr. Dorsey.
SMARTER SYMPTOM MONITORING
To make data collection easier, smartphones and tablets are being used in studies to take patients' vital signs, measure symptom severity, and deliver consent forms and questionnaires. For example, Dr. Dorsey says, researchers have developed an iPhone app that allows people with Parkinson's to fill out surveys about their symptoms and quality of life. The app also administers movement and memory tests, and patients can send voice recordings to their doctors to measure vocal tremors. They can use the smartphone's built-in accelerometer to measure their gait and posture, and use apps to take memory tests. “The smartphone can also passively monitor their activity and degree of socialization—how far they get outside of their home, for example,” says Dr. Dorsey. He and his colleagues aren't using the app in the Connect.Parkinson trial, but Dr. Dorsey says he is considering it for future studies.
Another plus for remote monitoring: Study participants can record their symptoms and side effects in real time, which “makes people feel more engaged in the process,” says Dr. LaRocca. It also means that what participants report is more accurate. In a standard trial, patients might go in for a monthly clinic visit and be asked to recall symptoms they experienced days or even weeks ago, he points out.
And the Intelligent Systems for Assessing Aging Change (ISAAC) trial, underway since 2001, suggests these technologies can help doctors detect changes in memory and physical function that could indicate Parkinson's disease or mild cognitive impairment (MCI), for example, before clinical symptoms appear. In the ISAAC trial, sensors have been placed around participants' homes to monitor physical activity, how much time they spend in a particular room, and how often they leave the house, says investigator Jeffrey A. Kaye, MD, FAAN, an endowed professor of neurology and biomedical engineering at Oregon Health & Science University, director of the NIA-Layton Aging and Alzheimer's Disease Center, and director of the geriatric neurology program at Portland VA Medical Center. Currently, the researchers are tracking 120 participants, who are about 85 years of age, in the Portland area.
In addition to tracking physical activity, participants' pill boxes are equipped with sensors so that the researchers can tell if they are sticking to their medication regimen or have forgotten to take their pills. They also track the number of phone calls made and received during the day—but they don't listen in, Dr. Kaye emphasizes—as a measure of socialization. Computer usage is also logged.
Once a week, the participants fill out a brief computer survey to track variables that can't be measured by this “smart home” technology. “We ask them to rate their pain on a classic 10-point scale; we ask them if they've been down or sad in the past three days; we ask if they've fallen or been injured; if they've gone to the hospital; or if they've had a medication change,” says Dr. Kaye. “These questions provide another window into how a person is functioning.”
Dr. Kaye and his colleagues found that subtle changes in people's movements or computer use—even how they move the mouse on the computer screen—can distinguish those who are developing MCI from those who are cognitively normal, a finding they published in the journal PLOS ONE in September 2015.
Thanks to these technologies and techniques, says Dr. Dorsey, “patient care is being driven back to the home, and we are thinking of ways to conduct clinical trials that better meet patients' needs.” This is exactly what the field needs right now, experts agree; after all, clinical trials should be all about the patients.
To learn more about the clinical trials featured in this story, and to find other home-based clinical trials, visit http://ClinicalTrials.gov.