Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2026-02-21 @ 9:24 PM
Study NCT ID:
NCT06592235
Status:
RECRUITING
Last Update Posted:
2024-09-19
First Post:
2024-08-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Awareness of Individuals with Chronic Lung Disease About Climate Change, Heat Waves, Air Pollution and Physical Activity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-09', 'studyFirstSubmitDate': '2024-08-27', 'studyFirstSubmitQcDate': '2024-09-09', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Air temperature', 'timeFrame': '1 week before other assessments', 'description': 'The air temperature of the province and district where the patients were located and lived one week before the assessment will be recorded from the open access website of the General Directorate of Meteorology of the Ministry of Environment and Urbanization (https://www.mgm.gov.tr/).'}, {'measure': 'Humidity level', 'timeFrame': '1 week before other assessments', 'description': 'The humidity level of the province and district where the patients were located and lived one week before the assessment will be recorded from the open access website of the General Directorate of Meteorology of the Ministry of Environment and Urbanization (https://www.mgm.gov.tr/).'}, {'measure': 'Wind speed', 'timeFrame': '1 week before other assessments', 'description': 'The wind speed of the province and district where the patients were located and lived one week before the assessment will be recorded from the open access website of the General Directorate of Meteorology of the Ministry of Environment and Urbanization (https://www.mgm.gov.tr/).'}, {'measure': 'Air pollution', 'timeFrame': '1st day', 'description': 'The province and district where the patients were located and lived in the last week before the assessment will be recorded and the air pollutant values of PM2.5, PM10, CO, NO2, SO2, NO, O3 in the settlement where they lived in the last week will be accessed from the open access website of the continuous monitoring center of the Ministry of Environment and Urbanization and will be recorded and used for analysis. (https://sim.csb.gov.tr/STN/STN\\_Report/StationDataDownloadNew).'}, {'measure': 'Cognitive assessment', 'timeFrame': '1st day', 'description': 'Standardized Mini Mental Test. will be used for cognitive assessment. It provides assessment of cognitive activities such as understanding, reading, remembering and performing actions consisting of eleven questions. It is scored between 0-30. \\< 18 (quite a lot of cognitive impairment), 18-22 (moderate cognitive impairment), 23-26 (low cognitive impairment), 27-30 (no cognitive impairment).'}, {'measure': 'Anxiety and depression assessment', 'timeFrame': '1st day', 'description': 'Hospital Anxiety and Depression Scale (HADS) will be used to assess anxiety and depression. Seven out of a total of 14 questions measure anxiety and seven questions assess depression. The answers are scored in a four-point Likert format and between 0 and 3. The lowest score that patients can get from both subscales is 0, and the highest score is 21.'}, {'measure': 'Assessment of quality of life', 'timeFrame': '1st day', 'description': 'The St. George Respiratory Questionnaire (SGRQ) will be used to assess disease-specific quality of life. The SGRQ is a questionnaire consisting of three categories that patients answer themselves, assessing symptoms, activities and the impact of their disease on their daily lives. The questionnaire consists of a total of 76 questions and is scored between zero and 100, with high scores indicating poor health status.'}, {'measure': 'Health literacy assessment', 'timeFrame': '1st day', 'description': 'The Rapid Assessment of Adult Health Literacy in Medicine (REALM) scale will be used for health literacy assessment. REALM tests people\\'s word recognition and pronunciation skills. It is a word recognition test in which 66 health-related words are given, with the words becoming increasingly more difficult. Patients will be asked to read all of these words out loud in order.'}, {'measure': 'Physical activity assessment', 'timeFrame': '1st day', 'description': 'Physical activity level will be assessed using the International Physical Activity Questionnaire (IPAQ) (Short Form). This questionnaire was designed as a short and long form to determine the physical activity and sedentary behavior levels of adults. The IPAQ short form consists of seven questions and provides information on the time spent in vigorous activity, moderate activity and walking activities, as well as the time spent sitting. Higher IPAQ scores reflect greater levels of physical activity. In addition, the step counts of the participants for the last week will be recorded from their smartphones.'}], 'secondaryOutcomes': [{'measure': 'Respiratory functions', 'timeFrame': '1st day', 'description': 'Respiratory function test values will be recorded from patient records.'}, {'measure': 'Body mass index', 'timeFrame': '1st day', 'description': 'Body mass index value will be calculated.'}, {'measure': 'Disease-related symptoms', 'timeFrame': '1st day', 'description': 'Disease-related symptoms (shortness of breath, cough and sputum) will be questioned and recorded.'}, {'measure': 'Socio-economic status', 'timeFrame': '1st day', 'description': 'Socio-economic status will be recorded.'}, {'measure': 'Education level', 'timeFrame': '1st day', 'description': 'Education level will be recorded.'}, {'measure': 'Dyspnea assessment', 'timeFrame': '1st day', 'description': 'Modified Medical Research Council (mMRC) dyspnea scale will be used for dyspnea assessment. mMRC dyspnea scale is a scale in which individuals choose the expression that best describes their dyspnea levels from five expressions related to shortness of breath. It easily evaluates shortness of breath due to its simplicity and reliability. Higher mMRC dyspnea scale scores indicate more severe dyspnea (breathlessness).'}, {'measure': 'Charlson Comorbidity Index', 'timeFrame': '1st day', 'description': 'Charlson Comorbidity Index (CCI) will be used to query accompanying comorbidities. Higher CCI scores indicate a greater burden of comorbid conditions.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Climate Change', 'Chronic Lung Disease', 'Air Pollution']}, 'referencesModule': {'references': [{'pmid': '24881071', 'type': 'BACKGROUND', 'citation': "D'Amato G, Cecchi L, D'Amato M, Annesi-Maesano I. Climate change and respiratory diseases. Eur Respir Rev. 2014 Jun;23(132):161-9. doi: 10.1183/09059180.00001714. No abstract available."}, {'pmid': '33406378', 'type': 'BACKGROUND', 'citation': 'Ebi KL, Vanos J, Baldwin JW, Bell JE, Hondula DM, Errett NA, Hayes K, Reid CE, Saha S, Spector J, Berry P. Extreme Weather and Climate Change: Population Health and Health System Implications. Annu Rev Public Health. 2021 Apr 1;42:293-315. doi: 10.1146/annurev-publhealth-012420-105026. Epub 2021 Jan 6.'}, {'pmid': '37591374', 'type': 'BACKGROUND', 'citation': 'Tran HM, Tsai FJ, Lee YL, Chang JH, Chang LT, Chang TY, Chung KF, Kuo HP, Lee KY, Chuang KJ, Chuang HC. The impact of air pollution on respiratory diseases in an era of climate change: A review of the current evidence. Sci Total Environ. 2023 Nov 10;898:166340. doi: 10.1016/j.scitotenv.2023.166340. Epub 2023 Aug 15.'}, {'pmid': '31916265', 'type': 'BACKGROUND', 'citation': 'Eguiluz-Gracia I, Mathioudakis AG, Bartel S, Vijverberg SJH, Fuertes E, Comberiati P, Cai YS, Tomazic PV, Diamant Z, Vestbo J, Galan C, Hoffmann B. The need for clean air: The way air pollution and climate change affect allergic rhinitis and asthma. Allergy. 2020 Sep;75(9):2170-2184. doi: 10.1111/all.14177. Epub 2020 Jan 30.'}, {'pmid': '3558716', 'type': 'BACKGROUND', 'citation': 'Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. doi: 10.1016/0021-9681(87)90171-8.'}]}, 'descriptionModule': {'briefSummary': 'Climate change is characterized by global temperature increase, melting of glaciers and increasing temperature of ocean waters. Increase in greenhouse gases such as nitrogen and carbon dioxide negatively affects air and water quality. Extreme events such as extreme heat waves, floods and hurricanes are events seen with climate change. It is known that climate change and air pollution have negative effects on public health. Its adverse effects are often seen in individuals with rhinosinusitis, asthma and chronic obstructive pulmonary disease. Air pollution is expected to increase due to the ongoing economic growth and population growth worldwide, resulting in more respiratory diseases and disease burden. This study aims to assess the awareness level of individuals with chronic lung disease on climate change, heat waves, air pollution and their interaction with physical activity and anxiety and depression levels, and to better understand the experiences of patients and learn their perspectives. Within the scope of the study, it is planned to provide patients brief information on this subject and receive feedback about this information.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Having a chronic lung disease (COPD, asthma, bronchiectasis, cystic fibrosis, interstitial lung disease)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria for the study:\n\n* Being 18 years of age or older,\n* Having a chronic lung disease (COPD, asthma, bronchiectasis, cystic fibrosis, interstitial lung disease) and being referred to the Cardiopulmonary Rehabilitation Unit of Hacettepe University, Faculty of Physical Therapy and Rehabilitation for cardiopulmonary physiotherapy and rehabilitation,\n* Being clinically stable,\n* Using a smartphone with a pedometer,\n* To cooperate with the tests to be conducted,\n* Being willing to participate in the study.\n\nExclusion criteria:\n\n* Having had an acute exacerbation or having changed medication in the last month,\n* Having a severe cardiovascular, orthopedic or neurological problem that may affect the tests.'}, 'identificationModule': {'nctId': 'NCT06592235', 'briefTitle': 'Awareness of Individuals with Chronic Lung Disease About Climate Change, Heat Waves, Air Pollution and Physical Activity', 'organization': {'class': 'OTHER', 'fullName': 'Hacettepe University'}, 'officialTitle': 'Assessment of Awareness of Individuals with Chronic Lung Disease on Climate Change, Heat Waves, Air Pollution, and Their Interactions with Physical Activity', 'orgStudyIdInfo': {'id': 'SBA 24/794'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Individuals with chronic obstructive lung disease', 'description': 'Individuals with chronic obstructive lung disease', 'interventionNames': ['Other: No intervention']}, {'label': 'Individuals with asthma', 'description': 'Individuals with asthma', 'interventionNames': ['Other: No intervention']}, {'label': 'Individuals with bronchiectasis', 'description': 'Individuals with bronchiectasis', 'interventionNames': ['Other: No intervention']}, {'label': 'Individuals with interstitial lung disease', 'description': 'Individuals with interstitial lung disease', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'No intervention', 'armGroupLabels': ['Individuals with asthma', 'Individuals with bronchiectasis', 'Individuals with chronic obstructive lung disease', 'Individuals with interstitial lung disease']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06100', 'city': 'Ankara', 'state': 'Ankara', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Aslihan Cakmak-Onal, PhD, PT', 'role': 'CONTACT', 'email': 'aslihancakmak90@gmail.com', 'phone': '+903123051576', 'phoneExt': '178'}, {'name': 'Aslihan Cakmak-Onal, PhD, PT', 'role': 'CONTACT'}, {'name': 'Naciye Vardar-Yagli, PhD, PT', 'role': 'CONTACT'}, {'name': 'Ziya Toros Selçuk, MD', 'role': 'CONTACT'}, {'name': 'Deniz İnal-İnce, PhD, PT', 'role': 'CONTACT'}, {'name': 'Melda Sağlam, PhD, PT', 'role': 'CONTACT'}, {'name': 'Ebru Çalık-Kütükcü, PhD, PT', 'role': 'CONTACT'}, {'name': 'Elif Kocaağa, MSc, PT', 'role': 'CONTACT'}, {'name': 'Aydan Aslı Aksel-Uylar, MSc, PT', 'role': 'CONTACT'}], 'facility': 'Hacettepe University Faculty of Physical Therapy and Rehabilitation', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'Aslihan Cakmak-Onal, PhD, PT', 'role': 'CONTACT', 'email': 'aslihancakmak90@gmail.com', 'phone': '+903123051576'}, {'name': 'Elif Kocaaga, MSc, PT', 'role': 'CONTACT', 'email': 'elifkocaaga86@gmail.com', 'phone': '+903123051576'}], 'overallOfficials': [{'name': 'Aslihan Cakmak-Onal, PhD, PT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hacettepe University'}, {'name': 'Naciye Vardar-Yagli, PhD, PT', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hacettepe University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hacettepe University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Aslihan Cakmak', 'investigatorAffiliation': 'Hacettepe University'}}}}