Continuous Monitoring of Patients With Chronic Obstructive Pulmonary Disease

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01741935

Acronym

CTC-Actiwise

Enrollment

Registered

2012-12-05

Start date

2012-11-30

Completion date

2013-08-31

Last updated

2013-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

40 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Sweden

Outcome results