The LifeBridge Health Cardiovascular Institute has launched a pilot study to evaluate the potential benefits of a wireless heart monitoring system for patients with moderate to severe heart failure. The system tracks weight, blood pressure and other measures, and automatically sends the information to doctors and staff at the Cardiovascular Institute. The study is looking at whether this approach, designed to be simple and easy-to-use, can result in better outcomes for patients with heart failure.
"With heart failure, sudden increases in body weight and other measures could indicate that the heart is having issues pumping blood and the patient's condition is worsening. However, these issues can often be corrected with early intervention, which is why telemonitoring has the potential to be so effective in keeping people out of the hospital," explains Mauro Moscucci, M.D., M.B.A., medical director of the LifeBridge Health Cardiovascular Institute and chief of medicine at Sinai Hospital of Baltimore.
He adds, "We are eager to see if this simplified system is associated with consistent use and if it can allow close monitoring of patients' conditions and optimal management without the need of frequent office visits. The eventual hope is that the system will be easy and cost-effective enough to expand telemonitoring to patients with less severe heart failure, with the ultimate goal of keeping people well and out of the hospital."
The study is the first clinical trial to include patient education and care plans developed by the American Heart Association (AHA) through its new technology initiative known as Connected Heart Health. By combining the medical monitoring with the Connected Heart Health information, researchers will look to see if the program may keep participants motivated over time, including modifying or changing behaviors.
"Connected Heart Health was designed with the patient in mind, stimulating engagement and active involvement in their health," says Janet Bettger, Sc.D., a health services researcher at the Duke Clinical Research Institute and an American Heart Association volunteer who helped developed the plans. "AHA is committed to evaluating how we can use innovative technology to reach large cross-sections of the population and improve health, and this study will give us valuable insight."
A key component of the study is the "ease of use" for participants. They receive training to take their own blood pressure, glucose levels and weight every day using devices that are specifically designed to be simple to use. These devices automatically send the daily readings (through a wireless connection) to the medical team at Sinai Hospital.
The doctors and other staff receive alerts if a participant's numbers are dangerously high, so they let the patient know and take whatever immediate action may be necessary. The researchers can also track changes over time, so they may be able to spot a potential medical problem before it becomes more serious.
"One of the challenges with telemonitoring has been getting patients to measure their blood pressure and weight consistently and report their results. We are interested to see if this remote wireless technology will make it simpler and easier for them to be more consistent. We are also looking at how we can use the information developed by the American Heart Association to keep participants motivated," explains Dr. Moscucci.
Patients receive an email daily with their AHA "CarePlan" activities. Along with a summary of their medical data, they can answer questions about how they feel, such as if they have any shortness of breath or if they are experiencing other symptoms. They can also enter details about how they are eating and exercising.
The AHA's Connected Heart Health program provides personalized information, based on the profile the patient builds. One person may receive a tip about low cholesterol foods, while another may take an interactive assessment on sleep - all aimed at keeping participants interested and engaged.
The monitoring system, developed by Ambio Health, can also send reminders to patients about taking their medicines and doing their daily health assessments. Ambio is also evaluating whether a more affordable telemonitoring system could potentially lead to broader use for patients with heart disease risk factors such as high blood pressure. (Due to the high cost, telemonitoring has traditionally been reserved for heart failure patients with more severe disease).
Although not usually part of heart failure telemonitoring, glucose monitoring is included in this study because people living with heart failure often have other chronic conditions, including diabetes.
The trial will enroll 50 people with moderate to severe heart failure who will receive three months of telemonitoring, along with a follow up one month later. Along with evaluating the clinical measurements (weight, blood pressure and blood sugar), researchers will look at quality of life measures (such as the ability to climb a flight of stairs or carry groceries), patient engagement, behavior changes and hospital readmissions.
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