Clinical trial NCT06497816: Health Literacy, Physical and Cognitive Function, Health-related Behaviors, and Quality of Life in COPD
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: COPD
Health Literacy
Health-Related Behavior
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2024-07-12
Enrollment: 144
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals with COPD and Healthy Controls

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.


Eligibility criteria: Inclusion criteria for the COPD group:

* 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.

Exclusion criteria for the COPD group:

* 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.

Inclusion criteria for the control group:

* Being willing to participate in the study and being over 40 years old
* Not having any known disease

Exclusion criteria for the control group:

* Not being able to cooperate with the tests to be performed
* Not being willing to participate in the study

Primary outcomes:
measure: Functional capacity
timeFrame: 1st day
measure: Health literacy
timeFrame: 1st day
measure: Health literacy
timeFrame: 1st day
measure: Cognitive function
timeFrame: 1st day
measure: Health-related behavior
timeFrame: 1st day
measure: Functional exercise capacity
timeFrame: 1st day
Secondary outcomes:
measure: Forced vital capacity
timeFrame: 1st day
measure: Forced expiratory volume in one second
timeFrame: 1st day
measure: forced expiratory volume in one second/forced vital capacity ratio
timeFrame: 1st day
measure: Peak expiratory flow
timeFrame: 1st day
measure: Forced mid-expiratory flow (FEF25-75)
timeFrame: 1st day
measure: Physical activity level
timeFrame: 1st day
measure: Assessment of quality of life
timeFrame: 1st day
measure: Activities of daily living
timeFrame: 1st day
measure: Assessment of quality of life
timeFrame: 1st day
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University Faculty of Physical Therapy and Rehabilitation
Study officials:
affiliation: Hacettepe University
name: Aslihan Cakmak-Onal, PhD, PT
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: Deniz Inal-Ince, PhD, PT
role: STUDY_DIRECTOR
affiliation: Hacettepe University
name: Elif Kocaaga, MSc, PT
role: PRINCIPAL_INVESTIGATOR
References: