ConnectedHeartHealth - Heart Failure Readmission Intervention

Coronary Artery Disease Clinical Trial

— CHH  

Official title:

ConnectedHeartHealth - Heart Failure Readmission Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03247608
• Other study ID #: IRB #2287
• Secondary ID: CHH
• Status: Completed
• Phase: N/A
• Start date: November 2015
• Est. completion date: October 9, 2017

Study information

• Verified date: February 2019
• Source: LifeBridge Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 9, 2017
• Est. primary completion date: October 9, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Diabetes Mellitus
• Heart Failure
• Myocardial Ischemia

Intervention

Behavioral:
• Ambio Health Remote Monitoring
Participants in the Connected Heart Health study will complete a 24 week CarePlan including education, biometric monitoring, and communication with the health care team members. Each day the participant will receive an email from Ambio Health with a daily task list that includes a variety of activities. These tasks include uploading biometrics (weight and blood pressure), completing assessment on self-management skills (nutrition, physical activity, and medication management), accessing educational content (videos, web links, interactive quizzes), participation in challenges, and communicating with the care team and care givers.

Locations

Country	Name	City	State
United States	Sinai Hospital of Baltimore	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
LifeBridge Health	American Heart Association (AHA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Re-admissions rate	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.	30 Days
Secondary	Compliance to guidelines measures	Additional study metrics will include compliance to evidence based guidelines using Get with the Guidelines HF measures.	30 Days
Secondary	Biometrics change	Additional study metrics will include change in biometrics from baseline to follow up for weight, blood pressure and pro-BNP.	30 Days