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. desember 2020 oppdatert av: 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.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Faktiske)
118
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Madrid, Spania, 28034
- Novartis Investigative Site
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Madrid, Spania, 28040
- Novartis Investigative Site
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Torremolinos, Spania, 29620
- Novartis Investigative Site
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Catalunya
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Barcelona, Catalunya, Spania, 08036
- Novartis Investigative Site
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Cataluña
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Barcelona, Cataluña, Spania, 08025
- Novartis Investigative Site
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Barcelona, Cataluña, Spania, 08035
- Novartis Investigative Site
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Girona, Cataluña, Spania, 17007
- Novartis Investigative Site
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L'Hospitalet de Llobregat, Cataluña, Spania, 08907
- Novartis Investigative Site
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Lerida, Cataluña, Spania, 25198
- Novartis Investigative Site
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Sant Boi de Llobregat, Cataluña, Spania, 08830
- Novartis Investigative Site
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Sant Cugat, Cataluña, Spania, 08190
- Novartis Investigative Site
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Sant Joan Despí, Cataluña, Spania, 08970
- Novartis Investigative Site
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Madrid
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Majadanonda, Madrid, Spania, 28220
- Novartis Investigative Site
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Gagnef, Sverige, 785 21
- Novartis Investigative Site
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Göteborg, Sverige
- Novartis Investigative Site
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Kungshamn, Sverige, 456 31
- Novartis Investigative Site
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Lund, Sverige, SE-221 85
- Novartis Investigative Site
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Lund, Sverige, 222 22
- Novartis Investigative Site
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Stockholm, Sverige, 113 61
- Novartis Investigative Site
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Östersund, Sverige, 831 83
- Novartis Investigative Site
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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
40 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
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: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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.
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Remote patient monitoring system including exacerbations of chronic pulmonary disease Tool - Patient Reported Outcome (EXACT PRO), Lung Monitor, and Pulse Oximeter
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Eksperimentell: Usual care
This group of patient will continue on their usual standard care as close to real life situation as possible.
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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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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The number of hospitalizations and emergency room visits for management of COPD exacerbation(s)
Tidsramme: 52 weeks
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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
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52 weeks
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Lenght of hospitalization
Tidsramme: 52 weeks
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Comparison of the average length of hospital stay for management of COPD exacerbation(s) between the two arms.
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52 weeks
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Time to first hospitalization
Tidsramme: 52 weeks
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Comparison of the time to first occurrence of hospitalization for management of COPD exacerbation(s) between the two arms.
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52 weeks
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Use of health care resources
Tidsramme: 52 weeks
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Comparison of the combined health care resource utilization (hospitalizations, unscheduled, scheduled office visits, telephone call contacts) for management of COPD between the two arms.
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52 weeks
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Number of medical visits
Tidsramme: 52 weeks
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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.
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52 weeks
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
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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
1. juni 2012
Primær fullføring (Faktiske)
1. januar 2014
Studiet fullført (Faktiske)
1. januar 2014
Datoer for studieregistrering
Først innsendt
4. desember 2012
Først innsendt som oppfylte QC-kriteriene
5. desember 2012
Først lagt ut (Anslag)
6. desember 2012
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
10. desember 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
8. desember 2020
Sist bekreftet
1. februar 2014
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CIDD001D2401
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