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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
118
Remote patient monitoring system including exacerbations of chronic pulmonary disease Tool - Patient Reported Outcome (EXACT PRO), Lung Monitor, and Pulse Oximeter
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.
Novartis Investigative Site
Barcelona, Catalonia, Spain
Novartis Investigative Site
Barcelona, Catalonia, Spain
Novartis Investigative Site
Barcelona, Catalonia, Spain
Novartis Investigative Site
Girona, Catalonia, Spain
Novartis Investigative Site
L'Hospitalet de Llobregat, Catalonia, Spain
Novartis Investigative Site
Lleida, Catalonia, Spain
Novartis Investigative Site
Sant Boi de Llobregat, Catalonia, Spain
Novartis Investigative Site
Sant Cugat del Vallès, Catalonia, Spain
Novartis Investigative Site
Sant Joan Despí, Catalonia, Spain
Novartis Investigative Site
Majadanonda, Madrid, Spain
...and 10 more locations
The number of hospitalizations and emergency room visits for management of COPD exacerbation(s)
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
Time frame: 52 weeks
Lenght of hospitalization
Comparison of the average length of hospital stay for management of COPD exacerbation(s) between the two arms.
Time frame: 52 weeks
Time to first hospitalization
Comparison of the time to first occurrence of hospitalization for management of COPD exacerbation(s) between the two arms.
Time frame: 52 weeks
Use of health care resources
Comparison of the combined health care resource utilization (hospitalizations, unscheduled, scheduled office visits, telephone call contacts) for management of COPD between the two arms.
Time frame: 52 weeks
Number of medical visits
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.
Time frame: 52 weeks
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