Climate ChangeNCT06592235
Awareness of Individuals with Chronic Lung Disease About Climate Change, Heat Waves, Air Pollution and Physical Activity
An observational study of Climate Change and Chronic Lung Disease, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Climate Change, Chronic Lung Disease, Air Pollution
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2024to 1 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Having a chronic lung disease (COPD, asthma, bronchiectasis, cystic fibrosis, interstitial lung disease)
Who may be able to join
- Being 18 years of age or older,
- 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,
- Being clinically stable,
- Using a smartphone with a pedometer,
- To cooperate with the tests to be conducted,
- Being willing to participate in the study.
Who cannot join
- Having had an acute exacerbation or having changed medication in the last month,
- Having a severe cardiovascular, orthopedic or neurological problem that may affect the tests.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Hacettepe University Faculty of Physical Therapy and Rehabilitation
Ankara, Ankara, 06100
Aslihan Cakmak-Onal, PhD, PT, +903123051576 ext. 178, aslihancakmak90@gmail.com
Aslihan Cakmak-Onal, PhD, PT
About this study
Official title: Assessment of Awareness of Individuals with Chronic Lung Disease on Climate Change, Heat Waves, Air Pollution, and Their Interactions with Physical Activity
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.
- Conditions
- Climate Change, Chronic Lung Disease, Air Pollution
- Being tested
- No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Individuals with chronic obstructive lung disease | Individuals with chronic obstructive lung disease Receives: Other: No intervention | |
| Individuals with asthma | Individuals with asthma Receives: Other: No intervention | |
| Individuals with bronchiectasis | Individuals with bronchiectasis Receives: Other: No intervention | |
| Individuals with interstitial lung disease | Individuals with interstitial lung disease Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Air temperature
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/).
Measured: 1 week before other assessments
Humidity level
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/).
Measured: 1 week before other assessments
Wind speed
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/).
Measured: 1 week before other assessments
Air pollution
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).
Measured: 1st day
Cognitive assessment
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).
Measured: 1st day
Anxiety and depression assessment
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.
Measured: 1st day
Assessment of quality of life
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.
Measured: 1st day
Health literacy assessment
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.
Measured: 1st day
Physical activity assessment
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.
Measured: 1st day
Secondary outcomes (7)
Respiratory functions
Respiratory function test values will be recorded from patient records.
Measured: 1st day
Body mass index
Body mass index value will be calculated.
Measured: 1st day
Disease-related symptoms
Disease-related symptoms (shortness of breath, cough and sputum) will be questioned and recorded.
Measured: 1st day
Socio-economic status
Socio-economic status will be recorded.
Measured: 1st day
Education level
Education level will be recorded.
Measured: 1st day
Dyspnea assessment
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).
Measured: 1st day
Charlson Comorbidity Index
Charlson Comorbidity Index (CCI) will be used to query accompanying comorbidities. Higher CCI scores indicate a greater burden of comorbid conditions.
Measured: 1st day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Sep 2024
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Climate ChangeStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aslihan Cakmak, Hacettepe University
- Investigators
- Aslihan Cakmak-Onal, PhD, PT, Principal investigator, Hacettepe UniversityNaciye Vardar-Yagli, PhD, PT, Study director, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06592235
- Sponsor's protocol ID
- SBA 24/794
- Status last verified
- Sep 2024
- First submitted
- 27 Aug 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24881071Ebi 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.
PubMed 33406378Tran 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.
PubMed 37591374Eguiluz-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.
PubMed 31916265Charlson 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.
PubMed 3558716
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Awareness of Individuals with Chronic Lung Disease on Climate Change, Heat Waves, Air Pollution, and Their Interactions with Physical Activity
- ClinicalTrials.gov ID
- NCT06592235
- Acronym / sponsor ID
- SBA 24/794
- Conditions
- Climate Change, Chronic Lung Disease, Air Pollution
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Individuals with chronic obstructive lung disease | – | Other: No interventionIndividuals with chronic obstructive lung disease |
| Individuals with asthma | – | Other: No interventionIndividuals with asthma |
| Individuals with bronchiectasis | – | Other: No interventionIndividuals with bronchiectasis |
| Individuals with interstitial lung disease | – | Other: No interventionIndividuals with interstitial lung disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Having a chronic lung disease (COPD, asthma, bronchiectasis, cystic fibrosis, interstitial lung disease)
Key inclusion criteria (6 listed)
- Being 18 years of age or older,
- 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,
- Being clinically stable,
- Using a smartphone with a pedometer,
- To cooperate with the tests to be conducted,
Key exclusion criteria (2 listed)
- Having had an acute exacerbation or having changed medication in the last month,
- Having a severe cardiovascular, orthopedic or neurological problem that may affect the tests.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | Individuals with asthma, Individuals with bronchiectasis, Individuals with chronic obstructive lung disease, Individuals with interstitial lung disease |
Primary outcome
Air temperature
Time frame: 1 week before other assessments
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/).
Humidity level
Time frame: 1 week before other assessments
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/).
Wind speed
Time frame: 1 week before other assessments
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/).
Air pollution
Time frame: 1st day
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).
Cognitive assessment
Time frame: 1st day
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).
Anxiety and depression assessment
Time frame: 1st day
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.
Assessment of quality of life
Time frame: 1st day
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.
Health literacy assessment
Time frame: 1st day
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.
Physical activity assessment
Time frame: 1st day
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.
7 secondary outcomes
Respiratory functions
Time frame: 1st day
Body mass index
Time frame: 1st day
Disease-related symptoms
Time frame: 1st day
Socio-economic status
Time frame: 1st day
Education level
Time frame: 1st day
Dyspnea assessment
Time frame: 1st day
Charlson Comorbidity Index
Time frame: 1st day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 24881071D'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.
- Background: PubMed 33406378Ebi 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.
- Background: PubMed 37591374Tran 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.
- Background: PubMed 31916265Eguiluz-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.
- Background: PubMed 3558716Charlson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aslihan Cakmak-Onal, PhD, PT principal investigator
Hacettepe University
Naciye Vardar-Yagli, PhD, PT study director
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Climate Change and Chronic Lung Disease, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aslihan Cakmak-Onal, PhD, PT (+903123051576, aslihancakmak90@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Air temperature (time frame: 1 week before other assessments). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06592235, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.