News | Remote Monitoring | May 26, 2016

New Study Evaluates Wireless Remote Monitoring System for Heart Failure Patients

Pilot project collaborates with American Heart Association to provide patients with education and support through telemonitoring system

Ambio Health telemonitoring system, LifeBridge Health Cardiovascular Institute, Baltimore, pilot study

May 26, 2016 — The LifeBridge Health Cardiovascular Institute, Baltimore, 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,” explained 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 added, “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,” said Janet Bettger, Sc.D., a health services researcher at the Duke Clinical Research Institute and an AHA 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,” explained 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.

For more information:

Related Content

Patient Enrollment Completed in U.S. IDE Study of THERMOCOOL SMARTTOUCH SF Catheter
News | Clinical Study | March 15, 2018
March 15, 2018 –  Johnson & Johnson Medical Devices Companies announced today that Biosense Webster, Inc., who wo
Lexington Begins HeartSentry Clinical Trial
News | Clinical Study | February 20, 2018
February 20, 2018 – Lexington Biosciences, Inc., a development-stage medical device company, announced the commenceme
Endologix Completes Patient Enrollment in the ELEVATE IDE Clinical Study
News | Clinical Study | February 06, 2018
February 6, 2018 – Endologix, a developer and marketer of treatments for aortic disorders, announced the completion o
12-Month Results from Veryan Medical's MIMICS-2 IDE Study Presented at LINC
News | Clinical Study | February 01, 2018
February 1, 2018 – Thomas Zeller (Bad Krozingen, Germany) presented the 12-month results from Veryan Medical’s MIMICS
LimFlow Completes U.S. Feasibility Study Enrollment, Receives FDA Device Status
News | Clinical Study | February 01, 2018
February 1, 2018 –  LimFlow SA, developer of minimally-inv
ESC 2017 late breaking trial hot line study presentations.
News | Clinical Study | September 12, 2017
September 12, 2017 – The European Society of Cardiology (ESC) Congress 2017 includes several Hot Line Late-breaking C
U.K., NHS studies, weekend effect, hospital admission, atrial fibrillation, heart failure
News | Clinical Study | June 28, 2016
New research shows patients admitted to National Health Service (NHS) hospitals in the United Kingdom for atrial...
stroke risk
News | Clinical Study | August 28, 2015
Most people assume strokes only happen to octogenarians, but recent evidence suggests that survivors of childhood can
Overlay Init