ConnectedHeartHealth - Heart Failure Readmission Intervention (CHH)
Primary Purpose
Diabetes Mellitus, Coronary Artery Disease, Heart Failure
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ambio Health Remote Monitoring
Sponsored by
About this trial
This is an interventional prevention trial for Diabetes Mellitus focused on measuring Ambio Health
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
Sites / Locations
- Sinai Hospital of Baltimore
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ambio Health Remote Monitoring
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Compliance to guidelines measures
Additional study metrics will include compliance to evidence based guidelines using Get with the Guidelines HF measures.
Biometrics change
Additional study metrics will include change in biometrics from baseline to follow up for weight, blood pressure and pro-BNP.
Full Information
NCT ID
NCT03247608
First Posted
August 9, 2017
Last Updated
February 27, 2019
Sponsor
LifeBridge Health
Collaborators
American Heart Association (AHA)
1. Study Identification
Unique Protocol Identification Number
NCT03247608
Brief Title
ConnectedHeartHealth - Heart Failure Readmission Intervention
Acronym
CHH
Official Title
ConnectedHeartHealth - Heart Failure Readmission Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
October 9, 2017 (Actual)
Study Completion Date
October 9, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LifeBridge Health
Collaborators
American Heart Association (AHA)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Coronary Artery Disease, Heart Failure
Keywords
Ambio Health
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ambio Health Remote Monitoring
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Ambio Health Remote Monitoring
Intervention Description
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.
Primary Outcome Measure Information:
Title
Re-admissions rate
Description
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.
Time Frame
30 Days
Secondary Outcome Measure Information:
Title
Compliance to guidelines measures
Description
Additional study metrics will include compliance to evidence based guidelines using Get with the Guidelines HF measures.
Time Frame
30 Days
Title
Biometrics change
Description
Additional study metrics will include change in biometrics from baseline to follow up for weight, blood pressure and pro-BNP.
Time Frame
30 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mauro Moscucci, MD
Organizational Affiliation
LifeBridge Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sinai Hospital of Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
ConnectedHeartHealth - Heart Failure Readmission Intervention
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