Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Remote Patient Monitoring, Usual care · 1 trial · 1 indication
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
| Arm | Type | Description |
|---|---|---|
| Remote patient monitoring | EXPERIMENTAL | 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. |
| Usual care | EXPERIMENTAL | This group of patient will continue on their usual standard care as close to real life situation as possible. |
| Name | Type | Description |
|---|---|---|
| Remote Patient Monitoring | DEVICE | Remote patient monitoring system including exacerbations of chronic pulmonary disease Tool - Patient Reported Outcome (EXACT PRO), Lung Monitor, and Pulse Oximeter |
| Usual care | OTHER | 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. |
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 lea...
Remote Patient Monitoring, Usual care is an investigational intervention being studied for use in chronic obstructive pulmonary disease (COPD) patients. It is being evaluated in a clinical trial to compare the effect of a remote monitoring system using the EXACT tool to reduce hospitalizations due to COPD exacerbations. The intervention is in Phase 1 development.
Remote Patient Monitoring, Usual care is being developed by Novartis AG, a company traded on the stock exchange under the ticker symbol NVS. The company is conducting clinical research to evaluate this intervention in patients with COPD.
Remote Patient Monitoring, Usual care is in Phase 1 clinical development. It is an investigational intervention and has not been approved by regulatory authorities. One clinical trial has been completed as part of its early-stage evaluation in COPD patients.
Remote Patient Monitoring, Usual care has been studied in one clinical trial registered as NCT01744028. This completed Phase 1 trial enrolled 118 participants and compared the effect of a remote monitoring system using the EXACT tool to reduce hospitalizations due to COPD exacerbations. The trial was conducted in Spain and Sweden.
Remote Patient Monitoring, Usual care is an investigational intervention being evaluated in a clinical trial. The trial compares a remote monitoring system using the EXACT tool against usual care to reduce hospitalizations due to COPD exacerbations. The intervention is distinct from standard care in that it involves remote patient monitoring.