Status:
COMPLETED
Evaluating Efficacy of Digital Health Technology in the Treatment of Congestive Heart Failure
Lead Sponsor:
Yale University
Collaborating Sponsors:
Boehringer Ingelheim
ZS
Conditions:
Congestive Heart Failure
Eligibility:
All Genders
18-79 years
Phase:
NA
Brief Summary
The purpose of this study is to determine the efficacy of three novel digital health technologies versus usual care in the management of congestive heart failure, as assessed by a primary outcome of i...
Detailed Description
Heart failure is the most common cause of mortality and morbidity in the United States and in Western Europe. However, patient etiology and prognosis varies considerably, and guidance about how to bes...
Eligibility Criteria
Inclusion
- Adults greater than or equal to 18 and less than 80 years of age
- Enrolled in one of Yale New Haven Hospital's Disease Management or Heart Failure-focused cardiology clinics
- Diagnosed with congestive heart failure (preserved or reduced ejection fraction with or without diabetes)
Exclusion
- Class IV heart failure
- Stage 4 or end stage renal disease (eGFR \< 30)
- Recipient of a heart transplant of ventricular assist device
- Under hospice care
- Dementia
- Incarceration
- Pregnancy
- Currently homeless or residing in an unstable living situation (i.e., transitional housing, rehab facility, etc.)
- Inability to consent
- Currently enrolled in a study investigating a digital health product or technology
- Life expectancy of less than 6 months as determined by clinical judgement of primary treating physician
- weight greater than 400 pounds
- unable to stand straight up for 30 seconds without assistance, such as from a cane, walker, or wall.
- non-English speaking
Key Trial Info
Start Date :
September 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2021
Estimated Enrollment :
182 Patients enrolled
Trial Details
Trial ID
NCT04394754
Start Date
September 21 2020
End Date
December 1 2021
Last Update
May 18 2023
Active Locations (1)
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1
Yale New Haven Hospital
New Haven, Connecticut, United States, 06520