NCT03247608

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable diabetes-mellitus

Timeline
Completed

Started Nov 2015

Typical duration for not_applicable diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

August 9, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 11, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 9, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 9, 2017

Completed
Last Updated

March 1, 2019

Status Verified

February 1, 2019

Enrollment Period

1.9 years

First QC Date

August 9, 2017

Last Update Submit

February 27, 2019

Conditions

Diabetes MellitusCoronary Artery DiseaseHeart Failure

Keywords

Ambio Health

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Compliance to guidelines measures

    30 Days

  • Biometrics change

    30 Days

Study Arms (1)

Ambio Health Remote Monitoring

EXPERIMENTAL

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

Interventions

Ambio Health Remote MonitoringBEHAVIORAL

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.

Ambio Health Remote Monitoring

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sinai Hospital of Baltimore

Baltimore, Maryland, 21215, United States

Location

MeSH Terms

Conditions

Diabetes MellitusCoronary Artery DiseaseHeart Failure

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesCoronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Mauro Moscucci, MD

    LifeBridge Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2017

First Posted

August 11, 2017

Study Start

November 1, 2015

Primary Completion

October 9, 2017

Study Completion

October 9, 2017

Last Updated

March 1, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)