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Compare the Effect of a Remote Monitoring System Using the EXACT Tool to Reduce Hospitalizations Due to Chronic Obstructive Pulmonary Disease (COPD) Exacerbations. EXACT = Exacerbations of Chronic Pulmonary Disease Tool. (PREMIERE)

8. december 2020 opdateret af: Novartis Pharmaceuticals

A 52-week Multi-center Randomized Trial to Evaluate Remote Patient Monitoring Using the EXACT Patient-reported Outcome Tool on Reduction of Hospitalizations From Exacerbations in Patients With Chronic Obstructive Pulmonary Disease as Compared to Those Managed by Usual Care

The purpose of this pilot study is to evaluate a remote patient monitoring (RPM) system using a daily PRO tool (EXACT = Exacerbations of Chronic Pulmonary Disease Tool), in preventing hospitalization from Chronic Obstructive Pulmonary Disease (COPD) exacerbations in a COPD population at high risk of exacerbation, compared to those managed by usual care.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This study uses two parallel groups of approximately 100 patients in each arm. After a screening period to confirm eligibility, patients will be randomized to either the RPM system group, or the usual care group. Both groups will be followed for 52 weeks until the end of study. There are only 4 planned study visits and patients will continue on their usual treatment.

The remote patient monitoring system will issue an alert to the clinical site once the established threshold change has been reached. The alert notification will require the clinical site to contact the patient and treat the patient based on clinical judgment and clinical practice. Patients in the usual care arm will be managed through their normally nurse/physician contact.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

118

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Spanien
      • Madrid, Spanien, 28034
        • Novartis Investigative Site
      • Madrid, Spanien, 28040
        • Novartis Investigative Site
      • Torremolinos, Spanien, 29620
        • Novartis Investigative Site
    • Catalunya
      • Barcelona, Catalunya, Spanien, 08036
        • Novartis Investigative Site
    • Cataluña
      • Barcelona, Cataluña, Spanien, 08025
        • Novartis Investigative Site
      • Barcelona, Cataluña, Spanien, 08035
        • Novartis Investigative Site
      • Girona, Cataluña, Spanien, 17007
        • Novartis Investigative Site
      • L'Hospitalet de Llobregat, Cataluña, Spanien, 08907
        • Novartis Investigative Site
      • Lerida, Cataluña, Spanien, 25198
        • Novartis Investigative Site
      • Sant Boi de Llobregat, Cataluña, Spanien, 08830
        • Novartis Investigative Site
      • Sant Cugat, Cataluña, Spanien, 08190
        • Novartis Investigative Site
      • Sant Joan Despí, Cataluña, Spanien, 08970
        • Novartis Investigative Site
    • Madrid
      • Majadanonda, Madrid, Spanien, 28220
        • Novartis Investigative Site
  • Sverige
      • Gagnef, Sverige, 785 21
        • Novartis Investigative Site
      • Göteborg, Sverige
        • Novartis Investigative Site
      • Kungshamn, Sverige, 456 31
        • Novartis Investigative Site
      • Lund, Sverige, SE-221 85
        • Novartis Investigative Site
      • Lund, Sverige, 222 22
        • Novartis Investigative Site
      • Stockholm, Sverige, 113 61
        • Novartis Investigative Site
      • Östersund, Sverige, 831 83
        • Novartis Investigative Site

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

40 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Outpatients with a diagnosis of Chronic Obstructive Pulmonary Disease (COPD), GOLD grade 2 or higher as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines, Updated 2011, including:
  • Current or ex-smokers with a smoking history of at least 10 pack years nt
  • Post-bronchodilator Forced Expiratory Volume in one second (FEV1) < 80% of the predicted normal value within 12 months prior to screening or at screening
  • Post-bronchodilator FEV1/FVC (Forced Vital Capacity) < 70% within 12 months prior to screening or at screening
  • A documented history of at least 2 COPD exacerbations requiring treatment with systemic corticosteroids and/or antibiotics in the previous 12 months prior to the screening visit, at least one of which required hospitalization.

Exclusion criteria:

  • Use of investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer.
  • Patients who have a COPD exacerbation not clinically resolved within 30 days prior to screening.
  • Patients with a history of asthma, indicated by (but not limited to) the onset of respiratory symptoms suggestive of asthma (such as cough, wheezing, shortness of breath) prior to age 40 years.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Remote patient monitoring
Remote patient monitoring system including the Exacerbations of Chronic Pulmonary Disease Tool (EXACT) tool can use changes in daily scores over a certain threshold level to alert notification to the clinical site. The site will contact the patient in order to determine the clinical significance associated with the change in score, and to treat the patient based on clinical judgment and clinical practice.
Enhed: Remote Patient Monitoring
Remote patient monitoring system including exacerbations of chronic pulmonary disease Tool - Patient Reported Outcome (EXACT PRO), Lung Monitor, and Pulse Oximeter
Eksperimentel: Usual care
This group of patient will continue on their usual standard care as close to real life situation as possible.
Andet: Usual care
Patients in the usual care arm will continue their normally established procedures of nurse/physician contact and evaluation, as is considered standard for each individual practitioner in the study.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The number of hospitalizations and emergency room visits for management of COPD exacerbation(s)
Tidsramme: 52 weeks
Comparison of the total number of hospitalizations and emergency room visits (combined) for management of Chronic Obstructive Pulmonary Disease (COPD) exacerbation(s) between the two arms
52 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Lenght of hospitalization
Tidsramme: 52 weeks
Comparison of the average length of hospital stay for management of COPD exacerbation(s) between the two arms.
52 weeks
Time to first hospitalization
Tidsramme: 52 weeks
Comparison of the time to first occurrence of hospitalization for management of COPD exacerbation(s) between the two arms.
52 weeks
Use of health care resources
Tidsramme: 52 weeks
Comparison of the combined health care resource utilization (hospitalizations, unscheduled, scheduled office visits, telephone call contacts) for management of COPD between the two arms.
52 weeks
Number of medical visits
Tidsramme: 52 weeks
Comparison of the number of medical visits combined (hospitalizations, emergency room visits, unscheduled and scheduled office visits) for management of COPD between the two arms.
52 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Novartis Pharmaceuticals

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juni 2012

Primær færdiggørelse (Faktiske)

1. januar 2014

Studieafslutning (Faktiske)

1. januar 2014

Datoer for studieregistrering

Først indsendt

4. december 2012

Først indsendt, der opfyldte QC-kriterier

5. december 2012

Først opslået (Skøn)

6. december 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. december 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. december 2020

Sidst verificeret

1. februar 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CIDD001D2401

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Remote Patient Monitoring in COPD Patients

Kliniske forsøg med Remote Patient Monitoring

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