ConnectedHeartHealth - Heart Failure Readmission Intervention

ConnectedHeartHealth - Heart Failure Readmission Intervention



Sponsors


Source

LifeBridge Health

Oversight Info

Has Dmc

No


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.

Overall Status

Recruiting

Start Date

2015-11-01

Completion Date

2018-03-01

Primary Completion Date

2018-03-01

Phase

N/A

Study Type

Interventional

Primary Outcome

Measure

Time Frame

Re-admissions rate
30 Days

Secondary Outcome

Measure

Time Frame

Compliance to guidelines measures
30 Days
Biometrics change
30 Days

Enrollment

50

Conditions


Intervention

Intervention Type

Behavioral

Intervention Name


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.

Arm Group Label

Ambio Health Remote Monitoring


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

Gender

All

Minimum Age

18 Years

Maximum Age

N/A

Healthy Volunteers

No


Overall Official

Last Name

Role

Affiliation

Mauro Moscucci, MD
Principal Investigator
LifeBridge Health

Overall Contact

Last Name

Alexander Yabut

Phone

410-601-5559

Email

[email protected]


Location

Facility

Status

Contact

Investigator

Sinai Hospital of Baltimore
Baltimore Maryland 21215 United States
Recruiting
Last Name: Alexander Yabut
Phone: 410-601-5559
Email: [email protected]
Last Name: Mauro Moscucci, MD
Role: Principal Investigator

Location Countries

Country

United States


Verification Date

2017-08-01

Lastchanged Date

2017-08-09

Firstreceived Date

2017-08-09

Responsible Party

Responsible Party Type

Sponsor


Keyword


Has Expanded Access

No

Condition Browse


Secondary Id

CHH

Number Of Arms

1

Arm Group

Arm Group Label

Ambio Health Remote Monitoring

Arm Group Type

Experimental

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.


Firstreceived Results Date

N/A

Overall Contact Backup

Last Name

Tonja Howell

Phone

410-601-8461

Email

[email protected]


Acronym

CHH

Firstreceived Results Disposition Date

N/A

Study Design Info

Intervention Model

Single Group Assignment

Primary Purpose

Prevention

Masking

No masking



ClinicalTrials.gov processed this data on August 11, 2017

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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