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Fjernovervåking av KOLS -pasienter som opplever en akutt forverring gjennom helseevalueringer ved bruk av bærbar mobilteknologi (COPD-BREATHE)

17. september 2026 oppdatert av: David Ruttens

Chronic obstructive pulmonary disease (COPD) causes about 3 million deaths annually and significantly burdens healthcare systems, costing the EU 38.6 billion euros, largely due to frequent hospitalizations triggered by acute exacerbations (AECOPD). AECOPD worsens patient health, accelerates lung decline, and lowers quality of life, highlighting the need for early detection. Moreover, these AECOPD events happen in an out-hospital setting and are therefore, not preventable. A clear clinical and quality-of-life need arises to reduce AECOPD-related events and consequent hospitalizations.

Mobile health (mHealth) offers a solution by monitoring patients remotely using unobtrusive wearable devices. Parameters like peripheral oxygen saturation (SpO2) and respiratory rate can detect and predict exacerbations. However, no data at home is available of AECOPD events and robust predictive algorithms are lacking. This study aims to monitor vital parameters at home, tracking physical activity, pulse, respiratory rate, SpO2, sleep, and skin temperature from the moment of ER admission until three months post-discharge. Data will be used to gain insight in the COPD progression following an AECOPD event and to construct a predictive model, enabling timely intervention, reducing hospitalizations, and improving outcomes.

Studieoversikt

Detaljert beskrivelse

Chronic obstructive pulmonary disease (COPD) is a common and life-threatening lung condition responsible for approximately three million deaths worldwide each year. The disease poses a substantial burden not only on individuals but also on healthcare systems. In the European Union, COPD accounts for 56% of annual healthcare costs related to respiratory diseases, equating to 38.6 billion euros.

A significant portion of these costs arises from the worsening of disease symptoms urging frequent (re)hospitalizations. These hospitalizations are typically triggered by flare-ups, also known as acute exacerbations of COPD (AECOPD). Such flare-ups often have a multifactorial origin e.g. bacterial or viral airway infection) and demand timely medical intervention to mitigate their impact.

AECOPD adversely affects the patient's health status, accelerates the decline in lung function, worsens prognosis, and significantly diminishes quality of life. Therefore, early detection of exacerbations is essential to prevent further disease progression and reduce hospital admissions.

Mobile health (mHealth) presents a promising solution for monitoring COPD patients at home remotely. Currently, the health of COPD patients outside of the hospital remains largely unmonitored-a "black box." By using wearable mobile technology to measure multiple parameters (e.g. oxygen saturation, respiratory rate, etc), it may become possible to predict disease worsening early and enable timely intervention. Previous studies have highlighted that monitoring peripheral oxygen saturation (SpO2) and respiratory rate can be useful in predicting AECOPD, but predicting algorithms are still lacking.

In this clinical study, following parameters will be monitored: physical activity, continuous heart rate, respiratory rate & breaths per minute, SpO2, sleep patterns, and core body temperature using a wearable mobile device. These parameters will be tracked from when patients are admitted to the emergency room (ER) until three months after hospital discharge or until rehospitalization due to AECOPD. The data collected will be used to gain insight in the COPD progression following an AECOPD event and construct a prediction model capable of forecasting disease deterioration. This model could enable timely medical intervention in the future, potentially preventing hospitalizations and improving patient outcomes.

Studietype

Intervensjonell

Registrering (Antatt)

50

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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

Studiesteder

    • Limburg
      • Genk, Limburg, Belgia, 3600
        • Ziekenhuis Oost-Limburg

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

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Provide signed and dated informed consent
  • Adults older than 18 years of age
  • Previously diagnosed with COPD
  • Speak and understand the Dutch language
  • Need for hospitalization

Exclusion Criteria:

  • Previous diagnosis of asthma
  • Not in the possession of a smartphone

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Patients admitted with an acute COPD exacerbation

Wearable mobile device

Patients admitted due to an acute COPD exacerbation will be asked to wear the wearable mobile device for a period of 3 months. An app linked to the device will be installed on their phone, and be used to send vital parameter data to the investigators.

During the time of hospital admission and at the end of study, a COPD Assessment Test questionnaire will be taken.

During the time of hospital admission, the patient will be asked to fill in the Digital Health Readiness Questionnaire

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Vital parameter stabilization
Tidsramme: From enrollment to the end of treatment at 3 months

Number of days until stabilization of vital parameters measured with help of a remote monitoring system.

From enrollment to the end of treatment at 3 months
Compliance rate
Tidsramme: From enrollment to the end of treatment at 3 months

Compliance rate to the remote monitoring system (expressed in %)

From enrollment to the end of treatment at 3 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in AECOPD symptoms
Tidsramme: From enrollment to the end of treatment at 3 months

Change in AECOPD symptoms, as measured by the COPD Assessment Test questionnaire

From enrollment to the end of treatment at 3 months
Correlation remote monitoring and subjective questionnaire
Tidsramme: From enrollment to the end of treatment at 3 months

The correlation between objectively measured remote monitoring data and a subjective questionnaire. As the questionnaire is mainly focused on COPD symptoms, the correlation will be made with the peripheral oxygen saturation data.

From enrollment to the end of treatment at 3 months

Samarbeidspartnere og etterforskere

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

Sponsor

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 (Faktiske)

1. mars 2025

Primær fullføring (Antatt)

3. november 2026

Studiet fullført (Antatt)

3. november 2026

Datoer for studieregistrering

Først innsendt

10. mars 2025

Først innsendt som oppfylte QC-kriteriene

17. mars 2025

Først lagt ut (Faktiske)

24. mars 2025

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

18. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

17. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • Z-2024106
  • B3712024000024 (Registeridentifikator: Belgian registration)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

Raw data regarding the vital parameter measurements will be shared with other researchers.

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ICF
  • ANALYTIC_CODE
  • CSR

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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