Ever since Bill Lyon was diagnosed with Parkinson's disease nine years ago, he has participated in about one clinical trial a year. In that same period, his wife, Marianne, his full-time caregiver, has participated in just one—but it made a huge difference, she says. "The experience helped me be more aware of what Bill is going through—and what we might prepare for as his disease progresses. When I filled out a questionnaire during the trial, most of the questions didn't pertain to me yet, but they may in the future."

As the Lyons' experience suggests, clinical trials for patients are plentiful while trials for caregivers are less common. But that's changing. A growing number of clinical trials are looking at ways to combat the stress, fatigue, health problems, and other challenges family caregivers face in a typical day.

"Research shows that a caregiver's health can decline during the caregiving journey," says C. Grace Whiting, president and chief executive officer of the National Alliance for Caregiving. "In response to that, we're seeing innovative research projects that capture health information about caregivers and how that impacts their role on the care team."

The trend coincides with a rise in the number of caregivers, a pattern that will most likely continue as baby boomers age. An estimated 43 million people care for a chronically ill, disabled, or elderly family member or friend during any given year, and they spend an average of more than 24 hours a week providing that care, according to a 2015 study by the National Alliance for Caregiving.

"Caregivers are the hidden patients," says Ana-Maria Vranceanu, founder and director of the Integrated Brain Health Clinical and Research Program at Massachusetts General Hospital in Boston. "They play an important role in the patient's emotional and physical health, often putting their own needs and self-care on hold in the process. Over time, their emotional and physical health can deteriorate, along with their ability to provide quality care."

Caregiving Is Stressful

Anyone who has taken care of someone with a chronic, progressive, neurologic disease knows how stressful the day-to-day demands can be—and research backs it up.

In a systematic review published in International Psychogeriatrics in 2014, Barry S. Oken, MD, PhD, FAAN, professor in the departments of neurology, behavioral neuroscience, and biomedical engineering at Oregon Health & Science University in Portland, found that people who care for family members with dementia experience substantial stress, which can affect their physical and emotional health and lead to more hospitalizations, higher medication usage, and an increased mortality rate. In fact, the mortality rate of caregivers is almost as high as it is for those with Alzheimer's disease, says Dr. Oken.

In 2015, Sarah Lageman, PhD, a psychologist in the department of neurology at Virginia Commonwealth University in Richmond, surveyed 66 caregivers of people with Parkinson's disease to determine what kind of support services they needed. The results, published in Geriatric Nursing, showed that almost half of respondents reported feeling stressed and needing help for financial, legal, and long-term care planning. They also wanted help in improving their relationships with the people for whom they were caring, as well as information about overall wellness and stress reduction for themselves. For their patients, caregivers said they wanted better access to neurologists and services such as physical therapy.

Stress Interventions

Dr. Vranceanu and her team are conducting a clinical trial to find ways to support caregivers of stroke patients, especially during and after hospitalization. In their study, patients and caregivers receive two 20-minute support sessions at the time of hospitalization, designed to help them manage the uncertainties of hospitalization. These sessions are followed by four "telehealth" sessions after the patient's discharge, which touch on self-care, interpersonal communication, role changes, and the adjustment to life after stroke.

Trial Flexibility

Many trials are also designed to accommodate the limited time caregivers have. So, for example, researchers might include five sessions instead of 10 or communicate with caregivers via teleconferencing instead of asking them to come to a clinic or lab, says David Roth, PhD, professor of geriatric medicine and director of the Center on Aging and Health at the Johns Hopkins School of Medicine in Baltimore.

Researchers are also using text messaging to find out what caregivers are doing in real time, says Nina Silverberg, PhD, director of the Alzheimer's Disease Centers Program at the National Institute on Aging. That data may help researchers pinpoint the type of support that may be most helpful, says Dr. Silverberg.

Customized Support

"There's an increasing appreciation that no one type of intervention is going to improve things, but maybe a combination of services and therapies will help," Dr. Roth says.

Researchers are also learning that not all caregivers are burned out. "There's this notion that caregivers are overburdened and need talk therapy," says Dr. Roth. "I prefer to see them as heroes who are doing well, and our job is to support them."

Specific Support

Research needs to continue, says Dr. Vranceanu. "Our 2016 study in the Journal of Critical Care suggests that rates of depression, anxiety, and post-traumatic stress at hospitalization are high for both patients and their informal caregivers, and caregiver resiliency factors such as mindfulness and healthy coping have a positive impact not only on the caregiver but also on the patient."

Dr. Vranceanu's team has also found that stress levels remain consistently high over a six-month period after hospitalization, showing that hospitalization is an important time to address not just physical recovery but also the emotional recovery of both patient and caregiver.

Part of the Picture

"I don't dread the future," says Marianne Lyon of her experience in a caregiver clinical trial and its impact on her ability to care for her husband. "But thanks to the trial, I'm very aware of how it might be for me as a caregiver. I'm also more cognizant of my friends who are caregivers and how hard it is on them because of the progression of the disease. I feel that I'm part of the big picture now."

Caregiver trials may not offer the chance to try a potentially valuable drug, and they often involve a great deal of time and effort, but participants may learn how to improve their own situations—and the data will help experts understand what kinds of interventions might assist others, says Dr. Silverberg.

Web Extra

To find a full list of trials for caregivers of people with neurologic conditions, visit clinicaltrials.gov and type "caregiver" and "neurologic disease" into the search bar. For a sampling of these types of trials, read about three at bit.ly/BrainLife-CareTrials.

What to Expect from a Caregiver Trial

There is no "typical" clinical trial for caregivers, but they share common activities, all aimed at strengthening the caregiver-patient bond and recognizing that the caregiver's health and well-being are critical to the patient's progress. These include:

• An evaluation of the caregiver's physical and emotional health.
• Education about the patient's illness, potential disease progression, and challenges to expect.
• Coping interventions such as mindfulness, taking "time outs," and practicing self-care.
• An introduction to the concept of collaborative care, in which the patient-caregiver relationship is understood as a true partnership.
• Coaching for the caregiver and patient in the hospital, and teleconferencing from home.