Clinical trial NCT03247608: ConnectedHeartHealth - Heart Failure Readmission Intervention
Official title: ConnectedHeartHealth - Heart Failure Readmission Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Coronary Artery Disease
Heart Failure
Keywords: Ambio Health
Lead sponsor: LifeBridge Health
Sponsor class: OTHER
Collaborators: name: American Heart Association (AHA)
First posted: 2017-08-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Re-admissions rate
timeFrame: 30 Days
Secondary outcomes:
measure: Compliance to guidelines measures
timeFrame: 30 Days
measure: Biometrics change
timeFrame: 30 Days
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Sinai Hospital of Baltimore
state: Maryland
Study officials:
affiliation: LifeBridge Health
name: Mauro Moscucci, MD
role: PRINCIPAL_INVESTIGATOR
References: