Continuous Monitoring of Patients With Chronic Obstructive Pulmonary Disease

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

COPD Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Respiratory Medicine & Allergology, Skånes universitetssjukhus Lund

Lund, SE-22185, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Improved real time physical activity

Time frame: 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 outcomes

The correlation of physical activity to disease symptom scores, lung function, and use of medication

Time frame: 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.

Sponsors and collaborators

Lead sponsor

CareTelCom AB

Industry

Collaborators

Boehringer Ingelheim
Lund University
Region Skane

Registry information

Official study title

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

Acronym: CTC-Actiwise

Important dates

Study start: 2012
Primary completion: 2013
Study completion: 2013
First posted: Dec 5, 2012
Registry last updated: Oct 31, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed