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.

NCT01744028 | Completed Phase 1

• 1 other identifier: CIDD001D2401
• Study Type: interventional
• Target: 118
• Locations: 2 countries
• Sites: 20

Brief Summary

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.

Conditions

Remote Patient Monitoring in COPD Patients

Keywords

COPD, remote patient monitoring, Hub, exacerbations, EXACT

Outcome Measures

Primary Outcomes (1)

• 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

  52 weeks

Secondary Outcomes (4)

• Lenght of hospitalization

  52 weeks

• Time to first hospitalization

  52 weeks

• Use of health care resources

  52 weeks

• Number of medical visits

  52 weeks

Study Arms (2)

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.

Device: Remote Patient Monitoring

Usual care

EXPERIMENTAL

This group of patient will continue on their usual standard care as close to real life situation as possible.

Other: Usual care

Interventions

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

Remote patient monitoring

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.

Usual care

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (20)

Novartis Investigative Site

Barcelona, Catalonia, 08025, Spain

Location

Novartis Investigative Site

Barcelona, Catalonia, 08035, Spain

Location

Novartis Investigative Site

Barcelona, Catalonia, 08036, Spain

Location

Novartis Investigative Site

Girona, Catalonia, 17007, Spain

Location

Novartis Investigative Site

L'Hospitalet de Llobregat, Catalonia, 08907, Spain

Location

Novartis Investigative Site

Lleida, Catalonia, 25198, Spain

Location

Novartis Investigative Site

Sant Boi de Llobregat, Catalonia, 08830, Spain

Location

Novartis Investigative Site

Sant Cugat del Vallès, Catalonia, 08190, Spain

Location

Novartis Investigative Site

Sant Joan Despí, Catalonia, 08970, Spain

Location

Novartis Investigative Site

Majadanonda, Madrid, 28220, Spain

Location

Novartis Investigative Site

Madrid, 28034, Spain

Location

Novartis Investigative Site

Madrid, 28040, Spain

Location

Novartis Investigative Site

Torremolinos, 29620, Spain

Location

Novartis Investigative Site

Gagnef, 785 21, Sweden

Location

Novartis Investigative Site

Gothenburg, Sweden

Location

Novartis Investigative Site

Kungshamn, 456 31, Sweden

Location

Novartis Investigative Site

Lund, 222 22, Sweden

Location

Novartis Investigative Site

Lund, SE-221 85, Sweden

Location

Novartis Investigative Site

Östersund, 831 83, Sweden

Location

Novartis Investigative Site

Stockholm, 113 61, Sweden

Location

Related Links

• Results for CIDD001D2401 can be found on the Novartis Clinical Trial Results Website

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2012
• First Posted: December 6, 2012
• Study Start: June 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: December 10, 2020

Record last verified: 2014-02

Locations

ES (13); SE (7)