Health Literacy, Physical and Cognitive Function, Health-related Behaviors, and Quality of Life in COPD
An Investigation of Health Literacy, Physical and Cognitive Function, Health-related Behaviors, and Quality of Life in Chronic Obstructive Pulmonary Disease and Healthy Individuals
1 other identifier
observational
144
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2024
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 15, 2024
CompletedFirst Submitted
Initial submission to the registry
June 28, 2024
CompletedFirst Posted
Study publicly available on registry
July 12, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 15, 2027
July 12, 2024
July 1, 2024
3 years
June 28, 2024
July 4, 2024
Conditions
Outcome Measures
Primary Outcomes (6)
Functional capacity
Functional capacity assessment using self-paced 6-minute walk test.
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.
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.
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.
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.
1st day
Functional exercise capacity
One-minute sit to stand test will be performed. The number of repetitions will be recorded.
1st day
Secondary Outcomes (9)
Forced vital capacity
1st day
Forced expiratory volume in one second
1st day
forced expiratory volume in one second/forced vital capacity ratio
1st day
Peak expiratory flow
1st day
Forced mid-expiratory flow (FEF25-75)
1st day
- +4 more secondary outcomes
Study Arms (2)
COPD
Individuals with stable COPD
Healthy Individuals
Healthy controls
Interventions
Eligibility Criteria
Individuals with COPD and Healthy Controls
You may qualify if:
- 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.
You may not qualify if:
- 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.
- Being willing to participate in the study and being over 40 years old
- Not having any known disease
- Not being able to cooperate with the tests to be performed
- Not being willing to participate in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hacettepe University Faculty of Physical Therapy and Rehabilitation
Ankara, 06100, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Aslihan Cakmak-Onal, PhD, PT
Hacettepe University
- STUDY DIRECTOR
Deniz Inal-Ince, PhD, PT
Hacettepe University
- PRINCIPAL INVESTIGATOR
Elif Kocaaga, MSc, PT
Hacettepe University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 28, 2024
First Posted
July 12, 2024
Study Start
June 15, 2024
Primary Completion (Estimated)
June 15, 2027
Study Completion (Estimated)
June 15, 2027
Last Updated
July 12, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share