Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01744028 | 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. | PHASE1 | COMPLETED | 118 | — | — | Jun 1, 2012 | Jan 1, 2014 | Dec 10, 2020 | 20 | Spain, Sweden |
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...