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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04550052
Other study ID # 00004060
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date August 13, 2020
Est. completion date December 31, 2026

Study information

Verified date May 2024
Source University of Rochester
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 36
Est. completion date December 31, 2026
Est. primary completion date December 31, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States University of Rochester Rochester New York

Sponsors (2)

Lead Sponsor Collaborator
University of Rochester Spire, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (6)

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 — View Citation

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 pneumo — View Citation

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. doi: 10.1016/s0749-3797(03)00207-1. — View Citation

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, M — View Citation

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 o — View Citation

Seefeldt V, Malina RM, Clark MA. Factors affecting levels of physical activity in adults. Sports Med. 2002;32(3):143-68. doi: 10.2165/00007256-200232030-00001. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 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. 30 Days
Primary 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. 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. 30 Days
Primary 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. 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. 30 Days
Primary 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. 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. 30 Days
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