Ignite Creation Date:
2025-12-24 @ 9:49 PM
Ignite Modification Date:
2026-01-02 @ 4:18 AM
Study NCT ID:
NCT04011332
Status:
COMPLETED
Last Update Posted:
2023-05-11
First Post:
2019-07-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nurse-led Integrated Care in COPD Patients With a Pulmonary Exacerbation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'monocentric parallel cluster design with a baseline period'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 69}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-10', 'studyFirstSubmitDate': '2019-07-04', 'studyFirstSubmitQcDate': '2019-07-04', 'lastUpdatePostDateStruct': {'date': '2023-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in CRQ (Chronic Respiratory Questionnaire) scores', 'timeFrame': 'at week one and week 13', 'description': 'Change in the four CRQ (Chronic Respiratory Questionnaire) subscores from week 1 to 13. The self-administered questionnaire version with standardised dyspnea questions (SAS) will be used. The questionnaire was developed for patients with chronic airflow limitations and comprises 20 items which assess four domains: 1) dyspnea, 2) fatigue, 3) emotional function and 4) mastery. The scoring scale ranges from 1 (extreme) to 7 (not at all) and will be assessed with a recall period of the past 2 weeks. A subscore for each domain (sum of items / number of items) will be calculated.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['integrated care', 'self-management'], 'conditions': ['COPD Exacerbation']}, 'referencesModule': {'references': [{'pmid': '39407408', 'type': 'DERIVED', 'citation': 'Schmid-Mohler G, Hubsch C, Braun J, Steurer-Stey C, Aregger C, Schaer DJ, Clarenbach C. Effect of a nurse-led integrated care intervention on quality of life and rehospitalisation in patients with severe exacerbation of COPD-a pilot study. Chron Respir Dis. 2024 Jan-Dec;21:14799731241291067. doi: 10.1177/14799731241291067.'}]}, 'descriptionModule': {'briefSummary': "The aim of the study is to evaluate the effect and effectiveness of the nurse-led integrated care programme for the management of COPD (Chronic Obstructive Pulmonary Disease) exacerbations on patients' quality of life, rehospitalisation and exacerbation rate, illness-related emotional distress, selected health behaviours and cost-utility at three months. Furthermore, understanding barriers and facilitators to implementation success is of interest."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with a confirmed diagnosis of COPD (GOLD 1-4)\n* Hospitalisation due to a COPD exacerbation and decision to start with steroids and/or antibiotics (severe exacerbation)\n* Age ≥ 18\n\nExclusion Criteria:\n\n* Cognitive impairment (dementia, delirium)\n* Not speaking German, French, Italian, English, Spanish, Portuguese, Serbian, Tamil, Hindi, Turkish or Slovakian'}, 'identificationModule': {'nctId': 'NCT04011332', 'acronym': 'NICCO', 'briefTitle': 'Nurse-led Integrated Care in COPD Patients With a Pulmonary Exacerbation', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Nurse-led Integrated Care to Improve Quality of Life in COPD Patients With a Pulmonary Exacerbation', 'orgStudyIdInfo': {'id': '2019-00797'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Group', 'interventionNames': ['Other: Integrated Care Model']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group'}], 'interventions': [{'name': 'Integrated Care Model', 'type': 'OTHER', 'description': 'The patients who are hospitalised due to a COPD exacerbation will be aligned to a nurse-led integrated care model for three months. The model constitutes a bundle of interventions that are commonly known as key elements in COPD management. In addition, the ANP-Team (Advanced Nursing Practice-Team) will coordinate the different health professionals within the hospital and across transitions within the three months.', 'armGroupLabels': ['Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8090', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'University Hospital Zurich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}