Remote Control
A new study is testing the effectiveness of a virtual home-based blood-pressure program for people with chronic hypertension.
Sherryl Lee has had high blood pressure for most of her life. For 50 years, the 76-year-old Kansas City, Kansas, native managed to keep it in check. But after her doctor died and then one of her medications was taken off the market in 2019, Lee started seeing another physician, who struggled to manage her condition.
“My blood pressure just went out of sight,” Lee said. “It [top number] could run anywhere from the 180s to 200, and then [the bottom number] was anywhere from the 90s up to 120.”
Lee switched doctors again, this time to internist Sheila McGreevy, M.D., at The University of Kansas Health System. McGreevy, also a clinical associate professor at the University of Kansas Medical Center, thought that the Lee would be a good candidate for a blood-pressure study being conducted by Aditi Gupta, M.D., associate professor in the Division of Nephrology and Hypertension.
One in three American adults ages 65 and older have hypertension, which can lead to heart problems, stroke and kidney disease. Over the past decade, high blood pressure has emerged as a risk factor for another health issue concerning older adults: cognitive decline and dementia. Yet only half of people with hypertension have their blood pressure under control.
A big part of the problem is that physicians rely on blood pressure readings taken in the doctor’s office, which are infrequent and often inaccurate, said Gupta. “Patients should have been sitting for five minutes first, not struggling to park their car and rushing into the clinic, and not chatting with the medical assistant while their blood pressure is being taken,” she said.
Even when blood pressure is taken in an ideal way, Gupta noted, it might be elevated in the clinic by temporary anxiety, a phenomenon known as “white coat hypertension.” Conversely, “masked hypertension” occurs when the reading taken in the clinic is normal even though it’s high at home. And most patients get their blood pressure checked just once or twice a year. Managing hypertension well requires more frequent readings.
Gupta and her co-investigators — Jeffrey Burns, M.D., co-director of the University of Kansas Alzheimer’s Disease Research Center, and Russell Waitman, Ph.D., now associate dean for informatics at the University of Missouri — were looking to change that. Funded by a five-year, $12 million grant from the National Institute on Aging, their study measures the effectiveness of a program that monitors blood pressure virtually through readings taken by patients at home.
After the researchers conducted a small pilot study to measure feasibility and safety, the trial, which tests the program’s effectiveness in controlling hypertension and in staving off cognitive decline, launched in the fall of 2021.
“Dr. McGreevy thought I would be a good candidate,” said Lee. “And they accepted me, and we went from there.”
Making it happen
Gupta and her colleagues plan to have enrolled 1,000 participants by the time the study, known as Remote Monitoring and Virtual Collaborative Care for Hypertension Control to Prevent Cognitive Decline, is completed. Because it’s a home-based program, they can include participants who are often excluded from other clinical trials, such as people who are frail or have limited mobility or transportation.
Potential participants are identified through The University of Kansas Health System’s electronic health record system and referred to the study team for screening and enrollment. They must be age 65 or older and have a systolic (top number) blood-pressure reading of at least 160 at a clinic visit, or at least 140 at two clinic visits.
Participants also come from University of Utah Health, which will help test the program across health systems. Gupta reached out to Srinivasan Beddhu, M.D., who now is the principal investigator at the Utah site, and asked him to participate.
The trial builds on a major study Beddhu was involved in, Gupta said. Known as SPRINT (Systolic Blood Pressure Intervention Trial), that study demonstrated that lowering systolic blood pressure to below 120 decreased the risk of heart disease and death much more effectively than the standard reduction to below 140. SPRINT also showed that this intensive lowering of the blood pressure was not harmful for cognitive function.
As Gupta noted, some clinicians believed that lowering blood pressure too much could reduce the blood flow in the brain enough to impair thinking and memory, but SPRINT suggested otherwise. It also showed that intensive blood pressure control (keeping it below 120) could prevent more than 100,000 deaths per year.
“The next step, now that we have the evidence, is to actually do it [lower blood pressure], to make it happen in the real world,” said Gupta.
"We have a deep knowledge and understanding of safety and of efficacy of these treatments. So we work to the highest level of our skillset and knowledge while freeing up the physician and the nurse to diagnose and provide care and perform other essential functions in a treatment plan."- Crystal Burkhardt, Pharm. D.
An app for that
Using a home-based program to lower blood pressure is not a new idea. The American College of Cardiology recommended home blood-pressure monitoring in their 2017 guidelines, but they did not specify how to supply patients with blood-pressure cuffs, how the readings make their way from patients’ homes to providers and how to manage the influx of those readings.
In addition to measuring how well such home-based hypertension program works to control high blood pressure and its effects, the KU researchers’ study serves as a guide for working out these kinds of logistics.
The program is also a prime example of remote patient monitoring (RPM), a growing field and subcategory of telehealth that lets providers monitor patients such as Lee outside of hospitals and clinics, typically in the patient’s home. RPM gives providers more data to help them make evidence-based decisions about their patients, improves access to care for underserved and rural patients who cannot always travel to a clinic and keeps patients involved in managing their own condition.
Patients in RPM programs use electronic devices, wearable monitors and apps to gather medical data that is then sent electronically to their health care provider. (See sidebar for a list of conditions that can be monitored using RPM devices.)
For this study, participants are given a wireless blood pressure cuff that connects to an app on the participant’s smartphone. They operate the cuff through the app, which then displays the reading and sends it on to an electronic hypertension dashboard at the University of Kansas Health System.
The readings on the dashboard are monitored by a team of pharmacists, another important feature of the program. Partnering with the study participants’ primary care doctors, the pharmacists are the primary point of contact for the readings and are authorized to make adjustments to prescribed medications.
“These are clinical pharmacists who go through additional training on chronic disease management, and they are qualified to manage patients with complex medical histories,” noted Gupta.
Crystal Burkhardt, Pharm.D., a clinical professor at the KU School of Pharmacy and a practicing clinical pharmacist at the health system who helped design the study, said these pharmacists function as an extension of the primary care physician. “We have a deep knowledge and understanding of safety and of efficacy of these treatments,” said. “So we work to the highest level of our skillset and knowledge while freeing up the physician and the nurse to diagnose and provide care and perform other essential functions in a treatment plan.”
The participants take several readings a week at home. The pharmacists monitor the readings by looking at the dashboard daily and make medication adjustments for the participants they are managing. The dashboard pings them with an alert if someone’s blood pressure is high, and it also alerts them if someone hasn’t been submitting readings so that they can reach out to that person. The pharmacists also touch base with the study participants by phone to discuss the blood pressure readings and ask about side effects. (Participants in the placebo group receive education and a blood-pressure cuff, but their readings were not monitored by a pharmacist.)
Of course, having more frequent readings means more data to manage, but Burkhardt notes that dashboard does some of the work for them. “It’s gives us ranges, it shows us the trends over time, and it helps us to quickly decipher, for example, ‘Is it the evening blood pressures or the morning blood pressures that are more concerning?’” she said. “So it's helping us to be smarter with adjusting those medications appropriately and tailoring it more for the patient.”
A real-world trial
Participants will be in the trial for two years, and the study will measure the effects of program manages on blood pressures and risk for heart attacks, stroke and other cardiovascular problems. The researchers will also test their study participants’ cognition using a battery of tests administered over the phone. The goal is to discover whether the participants who are receiving care via the home blood-pressure program experience less cognitive decline than those in the control group.
Keeping the blood vessels healthy is important to maintaining brain health, noted Burns.
“If clinicians in primary care can more effectively and aggressively treat hypertension, that has been shown to reduce the risk of mild cognitive impairment and dementia,” said Burns. “For instance, if we achieve better blood-pressure control in 100 people, we can prevent one or two of those individuals from developing cognitive impairment over the next five years. That might not sound like much, but if our team-oriented, home-based system can be scaled up and used elsewhere to manage thousands of patients, it can have a real public-health impact.”
Testing both how well the home blood-pressure program works and its effects on health in the same study saves time, Gupta noted — an important aspect of the study, given that implementing new evidence-based guidelines often takes years.
Since enrollment began in November 2021, more than 300 participants have entered the study, and Gupta, who noted the program could continue even after the funding for our grant is over, said she has received much positive feedback from physicians, pharmacists and participants. That includes Lee, whose blood pressure is back under control thanks to finally being prescribed the right mix of medications.
“I see why they call high blood pressure a silent killer because you never have any signs, and I've never had to go to the hospital behind my blood pressure. But I could generally always tell if my blood pressure was up because I would have headaches,” said Lee. “Now my headaches are very few and far between. Not only did KU lower my blood pressure, but I also feel great.”
CONDITIONS THAT CAN BE MONITORED AT HOME THROUGH RPM DEVICES
Remote patient monitoring enables health care providers to track and analyze their patients' conditions outside the hospital or clinic. Here are some common conditions that can be tracked with RPM devices:
