Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2026-02-20 @ 10:45 PM
Study NCT ID:
NCT02425293
Status:
COMPLETED
Last Update Posted:
2015-04-23
First Post:
2015-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
INCAS - Integrated Care of Asthma in Switzerland
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 223}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-20', 'studyFirstSubmitDate': '2015-04-10', 'studyFirstSubmitQcDate': '2015-04-20', 'lastUpdatePostDateStruct': {'date': '2015-04-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-04-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of patient characteristics between the intervention and the control group', 'timeFrame': 'baseline'}, {'measure': 'Comparison of asthma control between the intervention and the control group', 'timeFrame': 'baseline', 'description': 'Asthma control is measured using the Asthma Control Test (ACT).'}, {'measure': 'Comparison of patient satisfaction between the intervention and the control group', 'timeFrame': 'baseline', 'description': 'Patient satisfaction is measured using the Patient Assessment of Chronic Illness Care (PACIC 5A) questionnaire.'}], 'secondaryOutcomes': [{'measure': 'Comparison of asthma control at baseline and after one year in the intervention group.', 'timeFrame': 'baseline and follow up (after one year)', 'description': 'Analysis of change in asthma control (using the Asthma Control Test (ACT)) in the intervention group from baseline to follow up (after one year).'}, {'measure': 'Comparison of asthma control at baseline and after one year in the control group.', 'timeFrame': 'baseline and follow up (after one year)', 'description': 'Analysis of change in asthma control (using the Asthma Control Test (ACT)) in the control group from baseline to follow up (after one year).'}, {'measure': 'Comparison of patient satisfaction at baseline and after one year in the intervention group.', 'timeFrame': 'baseline and follow up (after one year)', 'description': 'Analysis of change in patient satisfaction (using the PACIC 5A questionnaire) in the intervention group from baseline to follow up (after one year).'}, {'measure': 'Comparison of patient satisfaction at baseline and after one year in the control group.', 'timeFrame': 'baseline and follow up (after one year)', 'description': 'Analysis of change in patient satisfaction (using the PACIC 5A questionnaire) in the control group from baseline to follow up (after one year).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': 'The aim of this study was to investigate the effect of standardized patient education on asthma control. In collaboration with two health insurance companies, pharmacists and pneumologists, patients with asthma were recruited. They completed the "Asthma Control Test (ACT)" and the "Patient Assessment of Chronic Illness Care (PACIC 5A)" questionnaire to assess asthma control and patients\' satisfaction with the health care service they received. Additionally, patients were offered the possibility to participate in a patient education seminar run by the Swiss lung leagues or the Swiss allergy centre (aha!). After one year, patients were asked to complete the questionnaires again. Comparisons of intraindividual changes and differences regarding ACT and PACIC 5A between patients with and without patient education were made.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '59 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with clinical asthma diagnosis\n* written informed consent\n\nExclusion Criteria:\n\n* inadequate knowledge of the German language\n* subjects with severe diseases with life expectancy under one year\n* subjects with known Chronic Obstructive Pulmonary Disease (COPD)'}, 'identificationModule': {'nctId': 'NCT02425293', 'acronym': 'INCAS', 'briefTitle': 'INCAS - Integrated Care of Asthma in Switzerland', 'organization': {'class': 'OTHER', 'fullName': 'Cantonal Hosptal, Baselland'}, 'orgStudyIdInfo': {'id': '274/11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Patients participating in a patient education seminar', 'interventionNames': ['Behavioral: asthma patient education']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Patients not participating in a patient education seminar'}], 'interventions': [{'name': 'asthma patient education', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Intervention']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cantonal Hosptal, Baselland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. med.', 'investigatorFullName': 'Prof. Dr. Jörg Leuppi', 'investigatorAffiliation': 'Cantonal Hosptal, Baselland'}}}}