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Wearable Technology in Heart Failure Patients (Wearables-HF)

12. juni 2026 oppdatert av: Wilson Tang, The Cleveland Clinic

Integration of Wearable Technology Data in Patients With or at Risk of Heart Failure

The primary objective is to establish a Cleveland Clinic-led registry designed to integrate continuous physiological data from consumer wearables, captured by the HeartBit app and a Case Western Reserve University (CWRU)-based platform, with clinical data from patients' individual Electronic Health Record (EHR). This proposal is for understanding the use of personal wearable devices (such as: Fitbit, and Apple Watch) to gather physiological data (such as: heart-rate, steps taken, sleep cycles, and calories expended) and correlate those data with self-reported health status. The research team intends to collect all of the data generated by the participant's personal wearable devices and to perform an integrated analysis of the physiological data generated by the wearable devices. The investigators specifically aim to uncover patterns from the data that they can evolve models from. The investigators' goal is to better predict and diagnose the adverse effects associated with daily lifestyle, including cardiovascular risk, musculoskeletal, metabolic risks, stress, and sleep disturbances. These data may be used to better understand the daily habits and lifestyle choices to possibly predict a person's health and disease risk to provide a more comprehensive diagnosis with early recognition and prevention. As wearable devices become more accurate and cheaper to purchase for the general public, integrative analysis of wearable data from multiple devices may lead to models that can be used by clinicians and basic scientists to make inferences about the daily lifestyle and its effects on health and disease.

Studieoversikt

Status

Rekruttering

Forhold

Hjertefeil

Studietype

Observasjonsmessig

Registrering (Antatt)

500

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Navn: Jennifer Wilcox
Telefonnummer: 216-636-6153
E-post: kirsopj@ccf.org

Studer Kontakt Backup

Navn: Valesha Province, MS
Telefonnummer: 216-636-6153
E-post: provinv@ccf.org

Studiesteder

Forente stater
- Ohio
  - Cleveland, Ohio, Forente stater, 44195
    - Rekruttering
    - Cleveland Clinic
    - Hovedetterforsker:
      
      W. H. Wilson Tang, MD
    - Ta kontakt med:
      
      Valesha Province, MS
      
      Telefonnummer: 216-636-6153
      
      E-post: provinv@ccf.org
    - Ta kontakt med:
      
      Jeniffer Wilcox
      
      Telefonnummer: 216-636-6153
      
      E-post: kirsopj@ccf.org

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

Voksen
Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

This prospective, observational registry will enroll adult participants, aged 18 to 85 years, who have been diagnosed with heart failure or are identified as being at risk of developing heart failure. The study aims to enroll an indefinite number of participants at Cleveland Clinic.

Beskrivelse

Inclusion Criteria:

Participants must be between 18 and 85 years of age.
Participants must have a diagnosis of heart failure or be identified as at risk of developing heart failure.
Participants must either own or be willing to acquire a compatible personal consumer-grade wearable device (such as Fitbit and Apple Watch) and must enroll via the HeartBit app.

Exclusion Criteria:

Individuals presenting with cognitive impairments or mental incapacity that would impede their understanding of, or cooperation with, the study protocol.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Establish Wearables Registry Tidsramme: 10 years	To establish a Cleveland Clinic-led registry that integrates continuous physiological data from consumer wearables, captured by the HeartBit app and a Case Western Reserve University-based platform, with comprehensive clinical and laboratory data from the Cleveland Clinic EHR.	10 years

Sekundære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Association between Wearable-derived Heart Rate and Clinical Outcomes Tidsramme: 10 years	To determine whether, and to what extent, changes in wearable-derived heart rate are associated with clinical outcomes, including hospitalizations, emergency department visits, and changes in laboratory markers.	10 years
Association between Wearable-derived Physical Activity and Clinical Outcomes Tidsramme: 10 years	To determine whether, and to what extent, changes in wearable-derived physical activity are associated with clinical outcomes, including hospitalizations, emergency department visits, and changes in laboratory markers.	10 years
Association between Wearable-derived Sleep Metrics and Clinical Outcomes Tidsramme: 10 years	To determine whether, and to what extent, changes in wearable-derived sleep metrics are associated with clinical outcomes, including hospitalizations, emergency department visits, and changes in laboratory markers.	10 years

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

The Cleveland Clinic

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. juni 2026

Primær fullføring (Antatt)

1. juni 2036

Studiet fullført (Antatt)

1. juni 2040

Datoer for studieregistrering

Først innsendt

9. juni 2026

Først innsendt som oppfylte QC-kriteriene

12. juni 2026

Først lagt ut (Faktiske)

16. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)