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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01741935
Recruitment Status : Completed
First Posted : December 5, 2012
Last Update Posted : October 31, 2013
Sponsor:
Collaborators:
Boehringer Ingelheim
Region Skane
Lund University
Information provided by (Responsible Party):
CareTelCom AB

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.


Condition or disease
COPD

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Study Type : Observational
Actual Enrollment : 25 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Is COPD Patient Mobility in Combination With Other Parameters a Sensitive Measure and Predictive Indicator for Early Detection of Exacerbations in COPD?
Study Start Date : November 2012
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
COPD patients
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01741935


Locations
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Sweden
Department of Respiratory Medicine & Allergology, Skånes universitetssjukhus Lund
Lund, Sweden, SE-22185
Sponsors and Collaborators
CareTelCom AB
Boehringer Ingelheim
Region Skane
Lund University
Investigators
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Principal Investigator: Leif Bjermer, Professor Lund University
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Responsible Party: CareTelCom AB
ClinicalTrials.gov Identifier: NCT01741935    
Other Study ID Numbers: CTC002.1
First Posted: December 5, 2012    Key Record Dates
Last Update Posted: October 31, 2013
Last Verified: October 2013