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

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 Overview

• Status: Recruiting
• Conditions: COPD; Health-Related Behavior; Health Literacy
• Intervention / Treatment: Other: No intervention

• Study Type: Observational
• Enrollment (Estimated): 144

Contacts and Locations

• Study Contact: Name: Aslihan Cakmak-Onal, PhD, PT; Phone Number: 178 03123051576; Email: aslihancakmak90@gmail.com
• Study Contact Backup: Name: Elif Kocaaga, MSc, PT; Email: elifkocaaga86@gmail.com

Study Locations

• Turkey
  • Ankara, Turkey, 06100
    • Recruiting
    • Hacettepe University Faculty of Physical Therapy and Rehabilitation
    • Contact: Aslihan Cakmak-Onal, PhD, PT; Phone Number: 178 03123051576; Email: aslihancakmak90@gmail.com
    • Principal Investigator: Aslihan Cakmak-Onal, PhD, PT
    • Sub-Investigator: Elif Kocaaga, MSc, PT
    • Sub-Investigator: Deniz Inal-Ince, PhD, PT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Individuals with COPD and Healthy Controls

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
COPD; Individuals with stable COPD	Other: No intervention; No intervention
Healthy Individuals; Healthy controls	Other: No intervention; No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Forced vital capacity	Pulmonary function test using a spirometer will be performed. Forced vital capacity will be recorded.	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.	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.	1st day
Peak expiratory flow	Pulmonary function test using a spirometer will be performed. Peak expiratory flow will be recorded.	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.	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.	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.	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.	1st day
Assessment of quality of life	Short Form-36 will be applied for assessing quality of life. Higher scores indicate better health status.	1st day

Collaborators and Investigators

• Sponsor: Hacettepe University
• Investigators: 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

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2024
• Primary Completion (Estimated): June 15, 2027
• Study Completion (Estimated): June 15, 2027

Study Registration Dates

• First Submitted: June 28, 2024
• First Submitted That Met QC Criteria: July 4, 2024
• First Posted (Actual): July 12, 2024

Study Record Updates

• Last Update Posted (Actual): July 12, 2024
• Last Update Submitted That Met QC Criteria: July 4, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: SBA24/414

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No