Continuous Monitoring of Patients With Chronic Obstructive Pulmonary Disease (CTC-Actiwise)

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

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.

Study Overview

• Status: Completed
• Conditions: COPD

• Study Type: Observational
• Enrollment (Actual): 25

Contacts and Locations

Study Locations

• Sweden
  • Lund, Sweden, SE-22185
    • Department of Respiratory Medicine & Allergology, Skånes universitetssjukhus Lund

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

COPD patients

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: CareTelCom AB
• Collaborators: Lund University; Boehringer Ingelheim; Region Skane
• Investigators: Principal Investigator: Leif Bjermer, Professor, Lund University

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: November 22, 2012
• First Submitted That Met QC Criteria: December 3, 2012
• First Posted (Estimate): December 5, 2012

Study Record Updates

• Last Update Posted (Estimate): October 31, 2013
• Last Update Submitted That Met QC Criteria: October 30, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: CTC002.1