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ConnectedHeartHealth - Heart Failure Readmission Intervention (CHH)

This study is currently recruiting participants.
Verified August 2017 by LifeBridge Health
Sponsor:
ClinicalTrials.gov Identifier:
NCT03247608
First Posted: August 11, 2017
Last Update Posted: August 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
American Heart Association (AHA)
Information provided by (Responsible Party):
LifeBridge Health
  Purpose
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.

Condition Intervention
Diabetes Mellitus Coronary Artery Disease Heart Failure Behavioral: Ambio Health Remote Monitoring

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: ConnectedHeartHealth - Heart Failure Readmission Intervention

Resource links provided by NLM:


Further study details as provided by LifeBridge Health:

Primary Outcome Measures:
  • Re-admissions rate [ Time Frame: 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:
  • Compliance to guidelines measures [ Time Frame: 30 Days ]
    Additional study metrics will include compliance to evidence based guidelines using Get with the Guidelines HF measures.

  • Biometrics change [ Time Frame: 30 Days ]
    Additional study metrics will include change in biometrics from baseline to follow up for weight, blood pressure and pro-BNP.


Estimated Enrollment: 50
Study Start Date: November 2015
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03247608


Contacts
Contact: Alexander Yabut 410-601-5559 ayabut@lifebridgehealth.org
Contact: Tonja Howell 410-601-8461 tjhowell@lifebridgehealth.org

Locations
United States, Maryland
Sinai Hospital of Baltimore Recruiting
Baltimore, Maryland, United States, 21215
Contact: Alexander Yabut    410-601-5559    ayabut@lifebridgehealth.org   
Contact: Tonja Howell    410-601-8461    tjhowell@lifebridgehealth.org   
Principal Investigator: Mauro Moscucci, MD         
Sponsors and Collaborators
LifeBridge Health
American Heart Association (AHA)
Investigators
Principal Investigator: Mauro Moscucci, MD LifeBridge Health
  More Information

Responsible Party: LifeBridge Health
ClinicalTrials.gov Identifier: NCT03247608     History of Changes
Other Study ID Numbers: IRB #2287
CHH ( Other Identifier: LifeBridge Health )
First Submitted: August 9, 2017
First Posted: August 11, 2017
Last Update Posted: August 11, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by LifeBridge Health:
Ambio Health

Additional relevant MeSH terms:
Diabetes Mellitus
Heart Failure
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases