A-SPIRE Heart Failure: Utilizing Physiologic Information From Spire Health Tags to Identify Heart Failure Patients At-Risk for Hospital Readmission: A Pilot Feasibility Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- University of Rochester
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- To ascertain the feasibility of capturing appropriate signals of sleep patterns for > 80% of the time in patients following HF hospitalization for a 30-day period.
Study Overview
Brief Summary
To evaluate the use of the Spire Health Tags in heart failure patients to determine the feasibility of capturing signals of respiration, pulse rate, activity, sleep patterns, and stress levels following HF hospitalization.
Detailed Description
Over 5 million Americans suffer from heart failure (HF), and treating HF as a chronic condition is associated with significant costs. In addition, about 24% of the patients discharged with a primary diagnosis of HF are readmitted to the hospital within 30 days, representing a significant public health burden. While there have been efforts to predict and reduce 30-day hospital readmission initiated by the Centers for Medicare and Medicaid Services (CMS), no studies utilized daily physiologic data from wearables to identify at-risk patients.
The overall goal of this proposed pilot feasibility study is to utilize the Spire Health Tags in a heart failure patient population to ascertain the feasibility of capturing appropriate signals of respiration, pulse rate, activity, sleep patterns, and stress levels (calm/focused/tense during the day) for > 80% of the time in patients following HF hospitalization for a 30-day period. The investigators will do exploratory analysis of the changes in these physiologic variables during a 30-day period following HF hospitalization to identify risk markers that could predict 30-day readmission.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Men and women 18 years of age or older;
- •Admitted for acute heart failure;
- •Expected to be discharged from hospitalization;
- •Able to give consent;
- •Willing to use the Spire Health Tags for 30 days continuously.
Exclusion Criteria
- •Unable or unwilling to participate in the study.
Outcomes
Primary Outcomes
To ascertain the feasibility of capturing appropriate signals of sleep patterns for > 80% of the time in patients following HF hospitalization for a 30-day period.
Time Frame: 30 Days
We will evaluate capturing data in at least 80% of the time (24 days of the 30 days) using the Spire Health Tags during a 30 day period.
To ascertain the feasibility of capturing appropriate signals of pulse rate for > 80% of the time in patients following HF hospitalization for a 30-day period.
Time Frame: 30 Days
We will evaluate capturing data in at least 80% of the time (24 days of the 30 days) using the Spire Health Tags during a 30 day period.
To ascertain the feasibility of capturing appropriate signals of activity for > 80% of the time in patients following HF hospitalization for a 30-day period.
Time Frame: 30 Days
We will evaluate capturing data in at least 80% of the time (24 days of the 30 days) using the Spire Health Tags during a 30 day period.
To ascertain the feasibility of capturing appropriate signals of stress levels (calm/focused/tense during the day) for > 80% of the time in patients following HF hospitalization for a 30-day period.
Time Frame: 30 Days
We will evaluate capturing data in at least 80% of the time (24 days of the 30 days) using the Spire Health Tags during a 30 day period.
Secondary Outcomes
No secondary outcomes reported
Investigators
Valentina Kutyifa
Associate Professor of Medicine (Cardiology)
University of Rochester