Continuous Monitoring of Patients With Chronic Obstructive Pulmonary Disease

COPD Clinical Trial

— CTC-Actiwise  

Official title:

Is COPD Patient Mobility in Combination With Other Parameters a Sensitive Measure and Predictive Indicator for Early Detection of Exacerbations in COPD?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01741935
• Other study ID #: CTC002.1
• Status: Completed
• Phase: N/A
• First received: November 22, 2012
• Last updated: October 30, 2013
• Start date: November 2012
• Est. completion date: August 2013

Study information

• Verified date: October 2013
• Source: CareTelCom AB
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Observational

Clinical Trial Summary

An open, single group, single center Study to confirm CTC-Actiwise™ as a means to record and monitor the progression of a patient's COPD.

Chronic Obstructive Pulmonary Disease (COPD) affects growing patient groups. Current knowledge about the disease limits the investigators ability to cure or interfere with the progression of the disease. COPD is often characterized by exacerbating infections requiring emergency care.

The project aims to examine whether disease progression of COPD can be better controlled by continuously monitoring the patient's physical activity, along with the assessment of pulmonary symptoms and lung function. A key question is: can investigators find indicators that provides support for early intervention before severe symptoms arise.

The patient carries a smartphone that records physical activity real-time, daily lung function measures, lung disease related symptoms, and use of medication.

The experimental phase, the first part of the project, covers 25 COPD patients followed up to 12 weeks where the primary objective is to examine and verify both new investigational methodology and technology.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 90 Years

Eligibility

Inclusion Criteria:

• Female or male 40 years of age and above

• Ability to use a smartphone and Bluetooth spirometer

• Subjects having COPD

• Ongoing treatment for a recent and not completely recovered COPD exacerbation

Exclusion Criteria:

• Dominating physical disability for other reasons or not related to COPD

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• COPD
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
Sweden	Department of Respiratory Medicine & Allergology, Skånes universitetssjukhus Lund	Lund

Sponsors (4)

Lead Sponsor	Collaborator
CareTelCom AB	Boehringer Ingelheim, Lund University, Region Skane

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improved real time physical activity	Improved health following an exacerbation is expected to be reflected by an increase in patient's physical activity performance recorded real time. The physical activity trend is compared with the trends in twice-daily recordings of symptom scores, use of rescue medication, and lung function. The correlation between the trends is measured.	Patients are continuously monitored up to 12 weeks	No
Secondary	The correlation of physical activity to disease symptom scores, lung function, and use of medication	Improved health following an exacerbation is expected to be reflected by an increase in patient's physical activity performance recorded real time. The physical activity trend is compared with the trends in twice-daily recordings of symptom scores, use of rescue medication, and lung function. The correlation between the trends is measured.	Patients are continuously monitored up to 12 weeks	No