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 |
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Recruitment Status :
Recruiting
First Posted : September 16, 2020
Last Update Posted : January 4, 2022
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| Condition or disease |
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| Heart Failure |
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 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 |
- 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.
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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 |
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.
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
| Contact: Valentina Kutyifa, MD, PhD | 1-585-275-2676 | valentina.kutyifa@heart.rochester.edu |
| 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 | |
| Principal Investigator: | Valentina Kutyifa, MD, PhD | University of Rochester |
| 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: | January 4, 2022 |
| Last Verified: | January 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Spire Health Tag |
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Heart Failure Heart Diseases Cardiovascular Diseases |