Continuous Monitoring of Patients With Chronic Obstructive Pulmonary Disease

Completed

• Conditions: COPD

• Registration Number: NCT01741935
• Lead Sponsor: CareTelCom AB

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-11-22
• Study First Submitted QC: 2012-12-03
• Study First Posted: 2012-12-05
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-30
• Last Update Posted: 2013-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improved real time physical activity	Patients are continuously monitored up to 12 weeks	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.

Secondary Outcome Measures

Name	Time	Method
The correlation of physical activity to disease symptom scores, lung function, and use of medication	Patients are continuously monitored up to 12 weeks	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.

Trial Locations

Locations (1)

Department of Respiratory Medicine & Allergology, Skånes universitetssjukhus Lund; 🇸🇪 Lund, Sweden