Continuous Monitoring of Patients With Chronic Obstructive Pulmonary Disease

NCT01741935 | Completed

• 1 other identifier: CTC002.1
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  Patients are continuously monitored up to 12 weeks

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

COPD patients

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• CareTelCom AB: lead
• Boehringer Ingelheim: collaborator
• Region Skane: collaborator
• Lund University: collaborator

Study Sites (1)

Department of Respiratory Medicine & Allergology, Skånes universitetssjukhus Lund

Lund, SE-22185, Sweden

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• Leif Bjermer, Professor

  Lund University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2012
• First Posted: December 5, 2012
• Study Start: November 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: October 31, 2013

Record last verified: 2013-10

Locations

SE (1)