A Phase 1 interventional study of Remote Patient Monitoring and Usual care in Remote Patient Monitoring in COPD Patients, sponsored by Novartis Pharmaceuticals. Completed at 20 sites in 2 countries. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2020-12-10.
Sponsored by Novartis Pharmaceuticals · Phase 1, Interventional, and Supportive 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.
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.
3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.
This study's enrollment of 118 is above the median of 72 across 2,118 interventional studies indexed under Lung Diseases.
Browse Lung Diseases studies →Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
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.
Device: Remote Patient Monitoring
This group of patient will continue on their usual standard care as close to real life situation as possible.
Other: Usual care
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.
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
This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Novartis Pharmaceuticals