Clinical trial 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.
Official title: A 52-week Multi-center Randomized Trial to Evaluate Remote Patient Monitoring Using the EXACT Patient-reported Outcome Tool on Reduction of Hospitalizations From Exacerbations in Patients With Chronic Obstructive Pulmonary Disease as Compared to Those Managed by Usual Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Remote Patient Monitoring in COPD Patients
Keywords: COPD, remote patient monitoring, Hub, exacerbations, EXACT
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2012-12-06
Enrollment: 118
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: 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.

Eligibility criteria: 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 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.

Exclusion criteria:

* 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.

Primary outcomes:
measure: The number of hospitalizations and emergency room visits for management of COPD exacerbation(s)
timeFrame: 52 weeks
Secondary outcomes:
measure: Lenght of hospitalization
timeFrame: 52 weeks
measure: Time to first hospitalization
timeFrame: 52 weeks
measure: Use of health care resources
timeFrame: 52 weeks
measure: Number of medical visits
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Cataluña
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Cataluña
city: Girona
country: Spain
facility: Novartis Investigative Site
state: Cataluña
city: L'Hospitalet de Llobregat
country: Spain
facility: Novartis Investigative Site
state: Cataluña
city: Lerida
country: Spain
facility: Novartis Investigative Site
state: Cataluña
city: Sant Boi de Llobregat
country: Spain
facility: Novartis Investigative Site
state: Cataluña
city: Sant Cugat
country: Spain
facility: Novartis Investigative Site
state: Cataluña
city: Sant Joan Despí
country: Spain
facility: Novartis Investigative Site
state: Cataluña
city: Majadanonda
country: Spain
facility: Novartis Investigative Site
state: Madrid
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Torremolinos
country: Spain
facility: Novartis Investigative Site
city: Gagnef
country: Sweden
facility: Novartis Investigative Site
city: Göteborg
country: Sweden
facility: Novartis Investigative Site
city: Kungshamn
country: Sweden
facility: Novartis Investigative Site
city: Lund
country: Sweden
facility: Novartis Investigative Site
city: Lund
country: Sweden
facility: Novartis Investigative Site
city: Stockholm
country: Sweden
facility: Novartis Investigative Site
city: Östersund
country: Sweden
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: