Continuous Monitoring of Patients With Chronic Obstructive Pulmonary Disease

NCT ID: NCT01741935

Last Updated: 2013-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-11-30

Study Completion Date

2013-08-31

Brief Summary

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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

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Conditions

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COPD

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role collaborator

Region Skane

OTHER

Sponsor Role collaborator

Lund University

OTHER

Sponsor Role collaborator

CareTelCom AB

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Leif Bjermer, Professor

Role: PRINCIPAL_INVESTIGATOR

Lund University

Locations

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Department of Respiratory Medicine & Allergology, Skånes universitetssjukhus Lund

Lund, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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CTC002.1

Identifier Type: -

Identifier Source: org_study_id