Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2025-12-25 @ 5:16 PM
Study NCT ID:
NCT05963503
Status:
RECRUITING
Last Update Posted:
2024-02-28
First Post:
2023-07-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Relationship Between Health Literacy and Physical Activity in Adult Patients With Cystic Fibrosis
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-26', 'studyFirstSubmitDate': '2023-07-19', 'studyFirstSubmitQcDate': '2023-07-19', 'lastUpdatePostDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Health Literacy', 'timeFrame': '5 minutes', 'description': 'Health literacy will be evaluated with Health Literacy Scale. This scale total score ranges from 25-125 and lower scores show that lower health literacy.'}], 'secondaryOutcomes': [{'measure': 'Anxiety and Depression', 'timeFrame': '5 minutes', 'description': 'Anxiety and depression will be evaluated with Hospital Anxiety and Depression Scale. A score of 11 or more indicates mood disorders. Anxiety or depression subscales score ranges from 0-21.'}, {'measure': 'Physical Activity', 'timeFrame': '3 minutes', 'description': 'Physical activity will be evaluated with International Physical Activity Questionnaire Short Form.'}, {'measure': 'Adherence to Airway Clearance Tecniques', 'timeFrame': '1 minute', 'description': 'Frequency of used airway clearance tecniques for a week'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cystic Fibrosis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study investigation of relationship between health literacy and physical activity, anxiety and depression, adherence to airway clearance techniques in adult patients with cystic fibrosis.', 'detailedDescription': 'The assessment will begin with demographic information then health literacy, depression and anxiety and physical activity level will evaluation with related questionnaires.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Cystic fibrosis and healthy participants between 18-65 years old.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nbe between the ages of 18-65 volunteering to participate\n\nExclusion Criteria:\n\nhaving any cardiopulmonary disease having cognitive problems being illiterate'}, 'identificationModule': {'nctId': 'NCT05963503', 'briefTitle': 'Relationship Between Health Literacy and Physical Activity in Adult Patients With Cystic Fibrosis', 'organization': {'class': 'OTHER', 'fullName': 'Hacettepe University'}, 'officialTitle': 'Investigation of Relationship Between Health Literacy and Physical Activity, Anxiety and Depression, Adherence to Airway Clearance Techniques in Adult Patients With Cystic Fibrosis', 'orgStudyIdInfo': {'id': 'GO 22/114'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cystic Fibrosis', 'description': 'Inclusion Criteria:\n\nhave a confirmed diagnosis of CF stable clinical condition 18-65 ages volunteering to participate\n\nExclusion Criteria:\n\nhaving a serious comorbidity that limits mobilization or participation in physical activity being illiterate having cognitive problems being pregnant incomplete answers to surveys', 'interventionNames': ['Other: Assessments']}, {'label': 'Controls', 'description': 'Inclusion Criteria:\n\n18-65 ages volunteering to participate\n\nExclusion Criteria:\n\nhaving any cardiopulmonary disease having cognitive problems being illiterate', 'interventionNames': ['Other: Assessments']}], 'interventions': [{'name': 'Assessments', 'type': 'OTHER', 'description': 'Health literacy Anxiety and depression Physical activity Adherence to airway clearance techniques', 'armGroupLabels': ['Controls', 'Cystic Fibrosis']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Aydan Aslı Aksel', 'role': 'CONTACT', 'email': 'aydanaaksel@gmail.com', 'phone': '+903123051576'}], 'facility': 'Hacettepe University', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'Aydan Aslı Aksel Uylar', 'role': 'CONTACT', 'email': 'aydanaaksel@gmail.com', 'phone': '+90312', 'phoneExt': '3051576'}], 'overallOfficials': [{'name': 'Naciye Vardar Yağlı', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hacettepe University'}, {'name': 'Ebru Damadoğlu', 'role': 'STUDY_CHAIR', 'affiliation': 'Hacettepe University'}, {'name': 'Oğuz Karcıoğlu', 'role': 'STUDY_CHAIR', 'affiliation': 'Hacettepe University'}, {'name': 'Aydan Aslı Aksel Uylar', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hacettepe University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hacettepe University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physiotherapist', 'investigatorFullName': 'Aydan Aslı Aksel Uylar', 'investigatorAffiliation': 'Hacettepe University'}}}}