NCT06592235

Brief 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. 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 27, 2024

Completed
5 days until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
18 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

11 months

First QC Date

August 27, 2024

Last Update Submit

September 9, 2024

Conditions

Outcome Measures

Primary Outcomes (9)

  • 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/).

    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/).

    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/).

    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).

    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).

    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.

    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.

    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.

    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.

    1st day

Secondary Outcomes (7)

  • Respiratory functions

    1st day

  • Body mass index

    1st day

  • Disease-related symptoms

    1st day

  • Socio-economic status

    1st day

  • Education level

    1st day

  • +2 more secondary outcomes

Study Arms (4)

Individuals with chronic obstructive lung disease

Individuals with chronic obstructive lung disease

Other: No intervention

Individuals with asthma

Individuals with asthma

Other: No intervention

Individuals with bronchiectasis

Individuals with bronchiectasis

Other: No intervention

Individuals with interstitial lung disease

Individuals with interstitial lung disease

Other: No intervention

Interventions

No intervention

Individuals with asthmaIndividuals with bronchiectasisIndividuals with chronic obstructive lung diseaseIndividuals with interstitial lung disease

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Having a chronic lung disease (COPD, asthma, bronchiectasis, cystic fibrosis, interstitial lung disease)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University Faculty of Physical Therapy and Rehabilitation

Ankara, Ankara, 06100, Turkey (Türkiye)

RECRUITING

Related Publications (5)

  • 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: 24881071BACKGROUND
  • 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: 33406378BACKGROUND
  • 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: 37591374BACKGROUND
  • 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: 31916265BACKGROUND
  • 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.

    PMID: 3558716BACKGROUND

Study Officials

  • Aslihan Cakmak-Onal, PhD, PT

    Hacettepe University

    PRINCIPAL INVESTIGATOR
  • Naciye Vardar-Yagli, PhD, PT

    Hacettepe University

    STUDY DIRECTOR

Central Study Contacts

Aslihan Cakmak-Onal, PhD, PT

CONTACT

Elif Kocaaga, MSc, PT

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 27, 2024

First Posted

September 19, 2024

Study Start

September 1, 2024

Primary Completion

August 1, 2025

Study Completion

August 1, 2025

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations