Ignite Creation Date:
2025-12-24 @ 10:04 PM
Ignite Modification Date:
2026-01-01 @ 9:57 AM
Study NCT ID:
NCT01741935
Status:
COMPLETED
Last Update Posted:
2013-10-31
First Post:
2012-11-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Continuous Monitoring of Patients With Chronic Obstructive Pulmonary Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-10-30', 'studyFirstSubmitDate': '2012-11-22', 'studyFirstSubmitQcDate': '2012-12-03', 'lastUpdatePostDateStruct': {'date': '2013-10-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improved real time physical activity', 'timeFrame': 'Patients are continuously monitored up to 12 weeks', 'description': "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."}], 'secondaryOutcomes': [{'measure': 'The correlation of physical activity to disease symptom scores, lung function, and use of medication', 'timeFrame': 'Patients are continuously monitored up to 12 weeks', 'description': "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."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['COPD']}, 'descriptionModule': {'briefSummary': "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.\n\nChronic 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.\n\nThe 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.\n\nThe patient carries a smartphone that records physical activity real-time, daily lung function measures, lung disease related symptoms, and use of medication.\n\nThe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'COPD patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female or male 40 years of age and above\n* Ability to use a smartphone and Bluetooth spirometer\n* Subjects having COPD\n* Ongoing treatment for a recent and not completely recovered COPD exacerbation\n\nExclusion Criteria:\n\n* Dominating physical disability for other reasons or not related to COPD'}, 'identificationModule': {'nctId': 'NCT01741935', 'acronym': 'CTC-Actiwise', 'briefTitle': 'Continuous Monitoring of Patients With Chronic Obstructive Pulmonary Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'CareTelCom AB'}, 'officialTitle': 'Is COPD Patient Mobility in Combination With Other Parameters a Sensitive Measure and Predictive Indicator for Early Detection of Exacerbations in COPD?', 'orgStudyIdInfo': {'id': 'CTC002.1'}}, 'contactsLocationsModule': {'locations': [{'zip': 'SE-22185', 'city': 'Lund', 'country': 'Sweden', 'facility': 'Department of Respiratory Medicine & Allergology, Skånes universitetssjukhus Lund', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}], 'overallOfficials': [{'name': 'Leif Bjermer, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lund University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CareTelCom AB', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, {'name': 'Region Skane', 'class': 'OTHER'}, {'name': 'Lund University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}