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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: August 1, 2022

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.

Clinical Trial Outcome Measures

Primary Measures

  • 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 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 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Rochester
  • Collaborator
    • Spire, Inc.
  • Provider of Information About this Clinical Study
    • Principal Investigator: Valentina Kutyifa, Associate Professor of Medicine (Cardiology) – University of Rochester
  • Overall Official(s)
    • Valentina Kutyifa, MD, PhD, Principal Investigator, University of Rochester
  • Overall Contact(s)
    • Valentina Kutyifa, MD, PhD, 1-585-275-2676, valentina.kutyifa@heart.rochester.edu

Citations Reporting on Results

Go AS, Mozaffarian D, Roger VL, Benjamin EJ, Berry JD, Blaha MJ, Dai S, Ford ES, Fox CS, Franco S, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Huffman MD, Judd SE, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Mackey RH, Magid DJ, Marcus GM, Marelli A, Matchar DB, McGuire DK, Mohler ER 3rd, Moy CS, Mussolino ME, Neumar RW, Nichol G, Pandey DK, Paynter NP, Reeves MJ, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Wong ND, Woo D, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Executive summary: heart disease and stroke statistics–2014 update: a report from the American Heart Association. Circulation. 2014 Jan 21;129(3):399-410. doi: 10.1161/01.cir.0000442015.53336.12.

Keenan PS, Normand SL, Lin Z, Drye EE, Bhat KR, Ross JS, Schuur JD, Stauffer BD, Bernheim SM, Epstein AJ, Wang Y, Herrin J, Chen J, Federer JJ, Mattera JA, Wang Y, Krumholz HM. An administrative claims measure suitable for profiling hospital performance on the basis of 30-day all-cause readmission rates among patients with heart failure. Circ Cardiovasc Qual Outcomes. 2008 Sep;1(1):29-37. doi: 10.1161/CIRCOUTCOMES.108.802686.

Dharmarajan K, Hsieh AF, Lin Z, Bueno H, Ross JS, Horwitz LI, Barreto-Filho JA, Kim N, Bernheim SM, Suter LG, Drye EE, Krumholz HM. Diagnoses and timing of 30-day readmissions after hospitalization for heart failure, acute myocardial infarction, or pneumonia. JAMA. 2013 Jan 23;309(4):355-63. doi: 10.1001/jama.2012.216476.

Amarasingham R, Patel PC, Toto K, Nelson LL, Swanson TS, Moore BJ, Xie B, Zhang S, Alvarez KS, Ma Y, Drazner MH, Kollipara U, Halm EA. Allocating scarce resources in real-time to reduce heart failure readmissions: a prospective, controlled study. BMJ Qual Saf. 2013 Dec;22(12):998-1005. doi: 10.1136/bmjqs-2013-001901. Epub 2013 Jul 31.

Fang J, Wylie-Rosett J, Cohen HW, Kaplan RC, Alderman MH. Exercise, body mass index, caloric intake, and cardiovascular mortality. Am J Prev Med. 2003 Nov;25(4):283-9.

Seefeldt V, Malina RM, Clark MA. Factors affecting levels of physical activity in adults. Sports Med. 2002;32(3):143-68. Review.

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