A-SPIRE-HF: A-SPIRE Heart Failure: Utilizing Health Tags to Identify Patients at Risk for Hospital Readmissions

Sponsor
University of Rochester (Other)
Overall Status
Recruiting
CT.gov ID
NCT04550052
Collaborator
Spire, Inc. (Industry)
100
1
28.6
3.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    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
    Actual Study Start Date :
    Aug 13, 2020
    Anticipated Primary Completion Date :
    Aug 1, 2022
    Anticipated Study Completion Date :
    Dec 31, 2022

    Outcome Measures

    Primary Outcome Measures

    1. 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. [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.

    2. 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. [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.

    3. 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. [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.

    4. 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. [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Rochester Rochester New York United States 14642

    Sponsors and Collaborators

    • University of Rochester
    • Spire, Inc.

    Investigators

    • Principal Investigator: Valentina Kutyifa, MD, PhD, University of Rochester

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Valentina Kutyifa, Associate Professor of Medicine (Cardiology), University of Rochester
    ClinicalTrials.gov Identifier:
    NCT04550052
    Other Study ID Numbers:
    • 00004060
    First Posted:
    Sep 16, 2020
    Last Update Posted:
    Jan 4, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Valentina Kutyifa, Associate Professor of Medicine (Cardiology), University of Rochester
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 4, 2022