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 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
118
Fas
- Fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Madrid, Spanien, 28034
- Novartis Investigative Site
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Madrid, Spanien, 28040
- Novartis Investigative Site
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Torremolinos, Spanien, 29620
- Novartis Investigative Site
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Catalunya
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Barcelona, Catalunya, Spanien, 08036
- Novartis Investigative Site
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Cataluña
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Barcelona, Cataluña, Spanien, 08025
- Novartis Investigative Site
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Barcelona, Cataluña, Spanien, 08035
- Novartis Investigative Site
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Girona, Cataluña, Spanien, 17007
- Novartis Investigative Site
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L'Hospitalet de Llobregat, Cataluña, Spanien, 08907
- Novartis Investigative Site
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Lerida, Cataluña, Spanien, 25198
- Novartis Investigative Site
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Sant Boi de Llobregat, Cataluña, Spanien, 08830
- Novartis Investigative Site
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Sant Cugat, Cataluña, Spanien, 08190
- Novartis Investigative Site
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Sant Joan Despí, Cataluña, Spanien, 08970
- Novartis Investigative Site
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Madrid
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Majadanonda, Madrid, Spanien, 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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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
40 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: 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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Experimentell: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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The number of hospitalizations and emergency room visits for management of COPD exacerbation(s)
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Lenght of hospitalization
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
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Sponsor
Publikationer och användbara länkar
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Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 juni 2012
Primärt slutförande (Faktisk)
1 januari 2014
Avslutad studie (Faktisk)
1 januari 2014
Studieregistreringsdatum
Först inskickad
4 december 2012
Först inskickad som uppfyllde QC-kriterierna
5 december 2012
Första postat (Uppskatta)
6 december 2012
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
10 december 2020
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
8 december 2020
Senast verifierad
1 februari 2014
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CIDD001D2401
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