ConnectedHeartHealth - Heart Failure Readmission Intervention

Not Applicable

Completed

• Conditions: Coronary Artery Disease; Diabetes Mellitus; Heart Failure
• Interventions: Behavioral: Ambio Health Remote Monitoring

• Registration Number: NCT03247608
• Lead Sponsor: LifeBridge Health

Brief Summary

This is a single-center, pilot study that will evaluate the effectiveness of the AHA science based CarePlans and the Ambio Health technology in improving the risk adjusted 30 day readmissions rate, patient compliance, and biometrics. The study will also be used to assess the feasibility of similar heart failure transition programs in the future.

Detailed Description

A key strategy of the Affordable Care Act is the Accountable Care Organization, designed to improve the quality of care, promote population health and reduce costs by making healthcare providers more accountable for health outcomes. With the increasing pressure to simultaneously improve care and reduce the overall cost of care, there is increasing need for better care coordination, especially for patients that are high risk for readmissions and poor health outcomes, to stay connected with their healthcare provider outside of the healthcare setting. Connected Heart Health is the American Heart Association's ACO (Accountable Care Organization) strategy for post-acute care. This includes evidence based CarePlans for heart failure, cardiac rehabilitation, and coronary artery disease. These CarePlans are brought to life with technology enabled by Ambio Health, which allows patients and doctors to be connected anytime and anywhere, encouraging the adoption of self-management skills, healthy living, and evidence based practice, resulting in fewer cardiovascular events and readmissions, and lower costs.

Ambio Health is an end-to-end remote patient monitoring system which includes a weight scale, blood pressure meter and blood glucose meter with wireless transmission of biometric readings through a home gateway to a web-based care management application that provides population health remote patient monitoring and engagement with automated delivery of the CarePlans.

Ambio Health will be introduced as a viable method for remote monitoring of heart failure patients, with an emphasis on reducing readmission rates and promoting self-management skills. This program is intended to implement the AHA's Connected Heart Health CarePlan and educational content for patients in conjunction with a platform designed to upload biometric data and provide care coordination as directed and implemented by discharging physicians/institutions. The intent is to design and execute a Pilot with Sinai Hospital of Baltimore.

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2017-08-09
• Study First Submitted QC: 2017-08-09
• Study First Posted: 2017-08-11
• Primary Completion: 2017-10-09
• Study Completion: 2017-10-09
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-27
• Last Update Posted: 2019-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Has a diagnosis of Heart Failure as measured by the New York Heart Association (NYHA) functional classification and is currently in functional class II- IV status.
• Have been hospitalized for an episode of acute HF decompensation within the last 30 days.
• Have access to the internet.
• Are physically and mentally capable to complete the monitoring process or have a caregiver capable of assisting in the use of the Ambio Health system.
• Willing and able to sign an informed consent form to participate in this evaluation for a duration of 180 days.

Exclusion Criteria

• Have a life expectancy of less than six months.
• Live in a nursing home other multi-member assisted living facility
• Intend to be away from their home for more than 2 weeks (14 days) total during the monitoring period.
• Are unable to read English at a minimum 5th grade level

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ambio Health Remote Monitoring	Ambio Health Remote Monitoring	Ambio Health is an end-to-end remote patient monitoring system which includes a weight scale, blood pressure meter and blood glucose meter with wireless transmission of biometric readings through a home gateway to a web-based care management application that provides population health remote patient monitoring and engagement with automated delivery of the CarePlans.

Primary Outcome Measures

Name	Time	Method
Re-admissions rate	30 Days	The primary endpoint will be the risk adjusted 30 day readmissions rate of the study population in comparison with the Sinai Hospital and the National Average.

Secondary Outcome Measures

Name	Time	Method
Compliance to guidelines measures	30 Days	Additional study metrics will include compliance to evidence based guidelines using Get with the Guidelines HF measures.
Biometrics change	30 Days	Additional study metrics will include change in biometrics from baseline to follow up for weight, blood pressure and pro-BNP.

Trial Locations

Locations (1)

Sinai Hospital of Baltimore; 🇺🇸 Baltimore, Maryland, United States