By Deborah Borfitz

July 29, 2019 | A growing body of caregiver research suggests that the people working tirelessly behind the scenes to get loved ones to and from their doctor appointments and through activities of daily living are themselves in need of some TLC. It's common sense to anyone who has ever been the unpaid but indispensable caregiver-in-chief to a family member, often years at a stretch with little if any respite.

The clinical research enterprise has traditionally shown little empathy for the plight of caregivers because trials seemed to have little to do with the person escorting participants to study visits, says Alyssa Lanzi, a post-doctoral fellow at the University of Delaware and ambassador for the Patient-Centered Outcomes Research Initiative (PCORI). In fact, caregivers play a critical role in the successful launch and completion of many clinical trials, including those testing therapies in people with cognitive deficits or limited mobility.

Research shows that the best way to incorporate the voice of caregivers is to ensure they have a role from the start—perhaps through focus groups, cognitive interviewing, or task analysis—when studies are being designed, says Lanzi. Study sponsors are generally waiting too long to get caregiver input and therefore learning too late about potential obstacles. If study visits are the only break caregivers get all week, for example, the protocol might collect their input online rather than have them complete lengthy questionnaires in the office.

Caregivers, especially those who are the legal guardian of a trial participant, "need to know better than anyone" the expectations of researchers and where to go for help if there's a problem, says Lanzi. They can help ensure compliance with a study protocol and probably had a big influence on their loved one's decision to sign up in the first place.

But it is problematic, if not unrealistic, to expect caregivers to shepherd an individual through a trial unassisted, says Elizabeth Allardice, a "caregiver survivor" and family advisory board member for the Concussion Legacy Foundation. A few years ago, she flew from Seattle, Washington to the Mayo Clinic in Rochester, Minnesota with her 42-year-old niece Stacy for a phase I clinical trial that involved injecting mice vaccine into a tumor in her heart. She was already an amputee, so making the trek alone was impossible even if it hadn't involved traversing "miles and miles of tunnels" to get to their destination on the Mayo campus, Allardice says.

The study was notable for how it fell short—no reimbursement for travel, no housing allowance, and no one to personalize the experience based on Stacy's fears, the questions she had, and what she wanted to know first, recalls Allardice. What it gave Stacy was her last-ditch hope to stay alive so she could spend more time with her children. And even that was nearly lost.

When the doctor began asking questions, it seemed to Stacy that he hadn't bothered to look at her medical record, says Allardice. She became agitated and just wanted to go home. "I asked the doctor to step out for a few minutes so I could talk to Stacy and calm her down and explain that this was just part of the process... they almost lost her in that study."

These are commonplace ordeals for caregivers, which can insidiously take a toll on their health. Allardice spent eight years caring for her husband full time before his death in 2014 from a degenerative brain disease called chronic traumatic encephalopathy (CTE). Only after dropping him off for a respite visit one morning did she notice she wasn't feeling so well herself. Her doctor diagnosed her with life-threatening sepsis, and she ended up in the hospital for seven days, followed by a series of operations—including heart surgery.

Insider's View

One of the daily challenges Allardice faced as a caregiver will sound familiar to smaller-framed women responsible for athlete-size men—the physicality of the job. "I'm 5-foot-4 and 130 pounds and my husband was 6-foot-4 and 220 pounds and sometimes fell eight to 10 times a day," she says. Repeatedly calling an ambulance was impractical. Allardice had a problem with no good answer every time her husband needed lifting or moving.

The medical community also never seemed to understand that her husband had a brain trauma and could not properly process information, Allardice says. He would get discharged from an inpatient stay based on his ability to perform functions of daily living, such as brushing his teeth and going to the bathroom—never realizing that he could do nothing without her explicit, step-by-step prompting. And after he fell and broke his nose and collar bone, she had to intervene so he would be given pain medication. He was clearly suffering but hadn't the capacity to consent to what would bring relief.

Caregivers can get to a point where they are so "completely and totally exhausted" that simply getting in and out of the car can be taxing, says Allardice. She remembers pulling into the parking garage with her husband, wishing valet parking was available or someone would come help get him out of the vehicle. "No one wants to sit their loved one on the curb while they go park the car, but if they both go into the parking garage it could take another 45 minutes just to get to the doctor's office."

Keeping On

From the stage at the CTE Conference of Boston University, Allardice has advocated for clinicians to more routinely ask caregivers about the services they might need during office visits with their loved one. She believes her words made a difference "by putting a face on the disease," she says. Better tending to the needs of caregivers would also be a way for clinical trials to more closely reflect all the hype in exhibit halls about patient-centricity, she adds.

"You've got to lead with empathy," says Allardice, and "trust that for the most part caregivers are going to have the most knowledge about the individual." She used to arrive at neurology appointments with a full rundown of changes to her husband's behaviors as observed by friends and family members. At a minimum, ask questions and give caregivers an opportunity to express themselves, she stresses.

Allardice attends the Concussion Legacy Foundation's annual Family Huddle when families of brain donors learn directly from researchers and program staff about how their donation has advanced science and informed policies protecting athletes and veterans. It was the first time she heard people say thank you and ask what they could do in return, which she says has been comforting as well as helped motivate her to help others.

The families of former football players diagnosed with CTE-induced dementia are among those who have turned to Allardice for support. Some family members of victims eventually get to the point where they "just want to move on with their life and not talk about it anymore," she says. "But for the greater part of us, we must. And so we do."

Knowledge is Power

It has been a trend at PCORI to put more focus on the needs of caregivers, says Lanzi, and that includes providing them with scholarships to attend the nonprofit’s annual meeting where they can learn about the kinds of patient-centered research being funded and applied in the real world. "A consumer of knowledge is extremely powerful when trying to advocate for their loved one and to build their own platform." The meeting also provides opportunities for caregivers to get directly involved as active members of research teams.

Caregiving is evolving across the lifespan and is now the sole focus of a growing body of research, says Lanzi. PCORI alone has funded hundreds of studies relevant to caregivers—including what they care about, how they make decisions and what helps reduce their burdens, which might have implications for clinical trials.

Lanzi was part of one PCORI-funded project last fall that brought caregivers together with researchers, clinicians, and patients to prioritize research for enhancing the lives of people with aphasia. Results of those trials could be used to improve the educational resources provided to caregivers involved in clinical trials, she says.

"At the University of Delaware, researchers are findings way to incorporate caregivers into studies to ensure the participant is a good match," she adds. "Patient-reported outcome measures can also be used to gain more information from the caregiver about the patient's everyday life. This information is necessary to ensure meaningful outcomes in research."

Applying the Research

A fair amount of research already exists about how to provide caregiver-specific support groups, especially for people caregiving for someone with Alzheimer's disease, says Lanzi, and many such programs have been implemented online. Much has also been published about the importance of providing caregivers with psychosocial support, "just having other people in the room who are also caregivers," and giving them enough resources to manage stress when they're feeling overwhelmed.

What has yet to be figured out is how to integrate some of these approaches into clinical research involving caregivers, says Lanzi. How can caregiver research be used to better educate family members about what to expect during a clinical trial? How can study sites better communicate the information and make caregivers feel comfortable asking questions and becoming an advocate for their loved one?

Building Research Initiatives by Developing Group Effort (BRIDGES) 2018 Conference was a big step in the right direction, says Lanzi. At the two-day event, researchers, clinicians, consumers, and family members collaboratively "shopped" for aphasia-related research topics and reached consensus on 11 research questions—e.g., “What is the best format of co-survivor support at each phase of the aphasia journey?” They then worked in research teams to move those projects forward.

Research has already uncovered a “disconnect” between the abilities of individuals with diminished cognitive skills and what caregivers perceive those abilities to be, Lanzi says, possibly because they do so much for or are too hard on their loved one. “That tells us we can’t just rely on the voice of the caregiver. We need to give the person with cognitive challenges a seat at the table, an opportunity to participate and engage and interact. So often we do a disservice to patients with cognitive impairments when we only speak about them rather than to them.”

Thanks to researchers in the field of cognitive communication, notably Michelle Bourgeois, there is no shortage of resources on how to have dementia-friendly conversations, says Lanzi. “You can’t just use the caregiver as a substitute for a person with dementia. That’s not appropriate at all.”

Since research assistants or coordinators are typically the ones seeing study participants, it makes sense to get them trained to communicate with people who are cognitively challenged, Lanzi says. Every state offers resources if not training programs on how to communicate with people with dementia, and most universities would have experts available who could provide training specific to dementia as well as stroke and Parkinson’s disease.

To save time and expense, she suggests sites use the train-the-trainer approach and designate one person to be the instructor for the rest of the study team and as new coordinators and assistants come on board. The bonus of having an in-house expert is that it could boost sites’ curb appeal with study sponsors, Lanzi notes. If the training is opened to caregivers, they will also be developing a better pool of potential study co-participants.