Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2026-01-31 @ 4:23 AM
Study NCT ID:
NCT02286050
Status:
COMPLETED
Last Update Posted:
2017-05-10
First Post:
2014-10-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of a Nursing Program for Patients With Cystic Fibrosis on Disease Management
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003550', 'term': 'Cystic Fibrosis'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-09', 'studyFirstSubmitDate': '2014-10-27', 'studyFirstSubmitQcDate': '2014-11-04', 'lastUpdatePostDateStruct': {'date': '2017-05-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-11-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Difference between baseline QoL and month 22', 'timeFrame': 'month 22', 'description': 'Self-reported QoL will be measured with the Cystic Fibrosis Questionnaire - revised (CFQ-R) and the VAS of the European Quality of Life Instrument - 5 dimensions (EQ-5D VAS).'}], 'primaryOutcomes': [{'measure': 'Difference between baseline patient satisfaction and month 22', 'timeFrame': 'month 22', 'description': 'Self-reported patient satisfaction will be measured with a newly developped questionnaire.'}], 'secondaryOutcomes': [{'measure': 'Difference between baseline adherence and month 22', 'timeFrame': 'month 22', 'description': 'Self-reported adherence to therapy will be measured with the Medication Adherence Report Scale (MARS) and a newly developped questionnaire.'}, {'measure': 'Difference between baseline self-efficacy and month 22', 'timeFrame': 'month 22', 'description': 'Self-reported self-efficacy to master the the therapeutic regimen will be measured with a newly developped questionnaire.'}, {'measure': 'Difference between baseline treatment burden and month 22', 'timeFrame': 'month 22', 'description': 'Self-reported treatment burden will be measured wiht a subscale of the CFQ-R.'}, {'measure': 'Difference between baseline trust and month 22', 'timeFrame': 'month 22', 'description': 'Self-reported trust will be measured with the short version of the Wake Forest Trust Scale.'}, {'measure': 'Difference between baseline information need and month 22', 'timeFrame': 'month 22', 'description': 'Information needs will be assessed with a subscale of the PICKER-questionnaire for patients with CF.'}]}, 'conditionsModule': {'conditions': ['Cystic Fibrosis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effect of a nursing program in patients with cystic fibrosis.', 'detailedDescription': 'All patients living with cystic fibrosis will be asked by questionnaire before (November 2014) and after (September 2016) the implementation of the program about their satisfaction with treatment, trust in the CF-Team, adherence, self-efficacy, treatment burden and quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cystic Fibrosis\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT02286050', 'briefTitle': 'Effect of a Nursing Program for Patients With Cystic Fibrosis on Disease Management', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Auswirkung Eines CF Nursing-Programms Auf Das Krankheitsmanagement Und Die Erfahrungen Der Behandlung Von Patientinnen Und Patienten', 'orgStudyIdInfo': {'id': 'SNCTP000000179'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CF Nursing Intervention', 'interventionNames': ['Other: CF Nursing Program']}], 'interventions': [{'name': 'CF Nursing Program', 'type': 'OTHER', 'armGroupLabels': ['CF Nursing Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8091', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'University Hospital Zurich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}