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

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ClinicalTrials.gov Identifier: NCT04550052
Recruitment Status : Recruiting
First Posted : September 16, 2020
Last Update Posted : September 16, 2020
Sponsor:
Collaborator:
Spire, Inc.
Information provided by (Responsible Party):
Valentina Kutyifa, University of Rochester

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
Heart Failure

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.

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Study Type : Observational
Estimated 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 : August 13, 2020
Estimated Primary Completion Date : August 1, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine





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. [ 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.

  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. [ 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.

  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. [ 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.

  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. [ 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients discharged following heart failure hospitalization,
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04550052


Contacts
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Contact: Valentina Kutyifa, MD, PhD 1-585-275-2676 valentina.kutyifa@heart.rochester.edu

Locations
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United States, New York
University of Rochester Recruiting
Rochester, New York, United States, 14642
Contact: Hannah G Kopin, MS    585-273-5247    hannah_kopin@urmc.rochester.edu   
Principal Investigator: Valentina Kutyifa, MD, PhD         
Sponsors and Collaborators
University of Rochester
Spire, Inc.
Investigators
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Principal Investigator: Valentina Kutyifa, MD, PhD University of Rochester
Publications of Results:

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Responsible Party: Valentina Kutyifa, Associate Professor of Medicine (Cardiology), University of Rochester
ClinicalTrials.gov Identifier: NCT04550052    
Other Study ID Numbers: 00004060
First Posted: September 16, 2020    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Valentina Kutyifa, University of Rochester:
Spire Health Tag
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases