COPDNCT06497816
Health Literacy, Physical and Cognitive Function, Health-related Behaviors, and Quality of Life in COPD
An observational study of COPD and Health Literacy, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Health literacy is important for controlling disease progression and living a healthy life with illness. High health literacy is associated with higher cognitive performance and lower health-related quality of life. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- COPD, Health Literacy, Health-Related Behavior
- How many people
- 144 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2024to 15 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals with COPD and Healthy Controls
Who may be able to join
- Being over 40 years old,
- Diagnosed with COPD and being clinically stable,
- Being able to cooperate with the tests to be performed,
- Not having any cardiovascular disease, orthopedic or neurological problems that may affect the tests,
- Being willing to participate in the study.
- Being willing to participate in the study and being over 40 years old
- Not having any known disease
Who cannot join
- Being in an acute exacerbation period,
- Having any cardiovascular disease, orthopedic or neurological problems that may affect the tests,
- Not being willing to participate in the study.
- Not being able to cooperate with the tests to be performed
- Not being willing to participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Elif Kocaaga, MSc, PT contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Hacettepe University Faculty of Physical Therapy and Rehabilitation
Ankara, Ankara, 06100
Aslihan Cakmak-Onal, PhD, PT, 03123051576 ext. 178, aslihancakmak90@gmail.com
Aslihan Cakmak-Onal, PhD, PT
About this study
Official title: An Investigation of Health Literacy, Physical and Cognitive Function, Health-related Behaviors, and Quality of Life in Chronic Obstructive Pulmonary Disease and Healthy Individuals
Health literacy is important for controlling disease progression and living a healthy life with illness. High health literacy is associated with higher cognitive performance and lower health-related quality of life. Physical, psychological, and social impairments are seen in chronic obstructive pulmonary disease (COPD). Studies investigating the relationship between health literacy and functional capacity, quality of life, physical activity, cognitive function, health-related behavior, and activities of daily living in individuals with COPD are limited. Therefore, the aim of this study was to compare individuals with COPD with healthy individuals in terms of health literacy, functional capacity, quality of life, physical activity, cognitive function, health-related behavior, and activities of daily living and to investigate the relationship between health literacy and functional capacity, quality of life, physical activity, cognitive function, health-related behavior, and activities of daily living in individuals with COPD.
- Conditions
- COPD, Health Literacy, Health-Related Behavior
- Being tested
- No intervention
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Health Behavior
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 |
|---|---|---|
| COPD | Individuals with stable COPD Receives: Other: No intervention | |
| Healthy Individuals | Healthy controls Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional capacity
Functional capacity assessment using self-paced 6-minute walk test.
Measured: 1st day
Health literacy
Test of Functional Health Literacy in Adults will be used to evaluate health literacy. The TOFHLA is scored on a scale of 0 to 100 and higher scores indicate higher health literacy.
Measured: 1st day
Health literacy
The Rapid Estimate of Adult Literacy in Medicine questionnaires will be performed. A score of 59 or less is defined as indicating low health literacy and a score of 60 or more indicates adequate health literacy.
Measured: 1st day
Cognitive function
Montreal Cognitive Assessment will be used to evaluate cognitive function. The Montreal Cognitive Assessment scores range between 0 and 30. A score of 26 or over is considered to be normal.
Measured: 1st day
Health-related behavior
Health-related Behavior Scale II will be performed to assess health-related behavior. The Health-related Behavior Scale II measures various health-related behaviors and is designed to assess the frequency or extent of engagement in these behaviors. Higher scores of the scale indicate more frequent or healthier behaviors, depending on the specific behavior being measured.
Measured: 1st day
Functional exercise capacity
One-minute sit to stand test will be performed. The number of repetitions will be recorded.
Measured: 1st day
Secondary outcomes (9)
Forced vital capacity
Pulmonary function test using a spirometer will be performed. Forced vital capacity will be recorded.
Measured: 1st day
Forced expiratory volume in one second
Pulmonary function test using a spirometer will be performed. Forced expiratory volume in one second will be recorded.
Measured: 1st day
forced expiratory volume in one second/forced vital capacity ratio
Pulmonary function test using a spirometer will be performed. Forced expiratory volume in one second/forced vital capacity ratio will be recorded.
Measured: 1st day
Peak expiratory flow
Pulmonary function test using a spirometer will be performed. Peak expiratory flow will be recorded.
Measured: 1st day
Forced mid-expiratory flow (FEF25-75)
Pulmonary function test using a spirometer will be performed. Forced mid-expiratory flow (FEF25-75) will be recorded.
Measured: 1st day
Physical activity level
Physical activity will be evaluated with International Physical Activity Questionnaire questionnaire. The questionnaire assesses physical activity across different domains, including leisure time, domestic and gardening activities, work-related activities, and transport-related activities. Scores are calculated based on the duration (minutes) and frequency (days) of these activities over the past seven days. Higher scores on the IPAQ indicate a higher level of physical activity.
Measured: 1st day
Assessment of quality of life
St. George quality of life questionnaire will be used to assess quality of life. Higher scores reflect worse health status.
Measured: 1st day
Activities of daily living
Activities of daily living will be evaluated using Leicester Cough Questionnaire. Each question is scored on a scale from 1 (maximum impact) to 7 (minimal impact). An average score is calculated for each domain (physical, psychological, and social), resulting in scores ranging from 1 to 7 per domain, and a total score between 3 and 21. A higher score indicates less impact.
Measured: 1st day
Assessment of quality of life
Short Form-36 will be applied for assessing quality of life. Higher scores indicate better health status.
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 posted12 Jul 2024
- Study start15 Jun 2024
- Primary completion15 Jun 2027 (estimated)
- Study completion15 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aslihan Cakmak-Onal, Hacettepe University
- Investigators
- Aslihan Cakmak-Onal, PhD, PT, Principal investigator, Hacettepe UniversityDeniz Inal-Ince, PhD, PT, Study director, Hacettepe UniversityElif Kocaaga, MSc, PT, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06497816
- Sponsor's protocol ID
- SBA24/414
- Status last verified
- Jun 2026
- First submitted
- 28 Jun 2024
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation of Health Literacy, Physical and Cognitive Function, Health-related Behaviors, and Quality of Life in Chronic Obstructive Pulmonary Disease and Healthy Individuals
- ClinicalTrials.gov ID
- NCT06497816
- Acronym / sponsor ID
- SBA24/414
- Conditions
- COPD, Health Literacy, Health-Related Behavior
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 15 Jun 2024 (actual)
- Primary completion
- 15 Jun 2027 (estimated)
- Study completion
- 15 Jun 2027 (estimated)
- First posted
- 12 Jul 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.
Health literacy is important for controlling disease progression and living a healthy life with illness. High health literacy is associated with higher cognitive performance and lower health-related quality of life. Physical, psychological, and social impairments are seen in chronic obstructive pulmonary disease (COPD). Studies investigating the relationship between health literacy and functional capacity, quality of life, physical activity, cognitive function, health-related behavior, and activities of daily living in individuals with COPD are limited. Therefore, the aim of this study was to compare individuals with COPD with healthy individuals in terms of health literacy, functional capacity, quality of life, physical activity, cognitive function, health-related behavior, and activities of daily living and to investigate the relationship between health literacy and functional capacity, quality of life, physical activity, cognitive function, health-related behavior, and activities of daily living in individuals with COPD.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COPD | – | Other: No interventionIndividuals with stable COPD |
| Healthy Individuals | – | Other: No interventionHealthy controls |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with COPD and Healthy Controls
Key inclusion criteria (7 listed)
- Being over 40 years old,
- Diagnosed with COPD and being clinically stable,
- Being able to cooperate with the tests to be performed,
- Not having any cardiovascular disease, orthopedic or neurological problems that may affect the tests,
- Being willing to participate in the study.
Key exclusion criteria (5 listed)
- Being in an acute exacerbation period,
- Having any cardiovascular disease, orthopedic or neurological problems that may affect the tests,
- Not being willing to participate in the study.
- Not being able to cooperate with the tests to be performed
- Not being willing to participate in the study
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 | COPD, Healthy Individuals |
Primary outcome
Functional capacity
Time frame: 1st day
Functional capacity assessment using self-paced 6-minute walk test.
Health literacy
Time frame: 1st day
Test of Functional Health Literacy in Adults will be used to evaluate health literacy. The TOFHLA is scored on a scale of 0 to 100 and higher scores indicate higher health literacy.
Health literacy
Time frame: 1st day
The Rapid Estimate of Adult Literacy in Medicine questionnaires will be performed. A score of 59 or less is defined as indicating low health literacy and a score of 60 or more indicates adequate health literacy.
Cognitive function
Time frame: 1st day
Montreal Cognitive Assessment will be used to evaluate cognitive function. The Montreal Cognitive Assessment scores range between 0 and 30. A score of 26 or over is considered to be normal.
Health-related behavior
Time frame: 1st day
Health-related Behavior Scale II will be performed to assess health-related behavior. The Health-related Behavior Scale II measures various health-related behaviors and is designed to assess the frequency or extent of engagement in these behaviors. Higher scores of the scale indicate more frequent or healthier behaviors, depending on the specific behavior being measured.
Functional exercise capacity
Time frame: 1st day
One-minute sit to stand test will be performed. The number of repetitions will be recorded.
9 secondary outcomes
Forced vital capacity
Time frame: 1st day
Forced expiratory volume in one second
Time frame: 1st day
forced expiratory volume in one second/forced vital capacity ratio
Time frame: 1st day
Peak expiratory flow
Time frame: 1st day
Forced mid-expiratory flow (FEF25-75)
Time frame: 1st day
Physical activity level
Time frame: 1st day
Assessment of quality of life
Time frame: 1st day
Activities of daily living
Time frame: 1st day
Assessment of quality of life
Time frame: 1st day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- 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.
Elif Kocaaga, MSc, PT contact
Aslihan Cakmak-Onal, PhD, PT principal investigator
Hacettepe University
Deniz Inal-Ince, PhD, PT study director
Hacettepe University
Elif Kocaaga, MSc, PT principal investigator
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 COPD and Health Literacy, 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 7 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 25 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aslihan Cakmak-Onal, PhD, PT (03123051576 ext. 178, aslihancakmak90@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional capacity (time frame: 1st day). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jun 2026; AzTrials last refreshed its copy on 7 Nov 2026.