Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-04-05 @ 7:46 PM
Study NCT ID:
NCT07419451
Status:
RECRUITING
Last Update Posted:
2026-02-19
First Post:
2026-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Health Literacy and Osteoporosis Awareness
Sponsor:
Bandırma Onyedi Eylül University
Organization:
Study Overview
Official Title:
Health Literacy and Osteoporosis Awareness Levels Among Individuals in the Age Group at Risk for Osteoporosis: A Descriptive Cross-Sectional Study
Status:
RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Osteoporosis (OP) is defined as a progressive metabolic bone disease characterized by low bone mass and deterioration of the microarchitecture of bone tissue, resulting in increased bone fragility and a higher risk of fractures. Osteoporosis and related fractures constitute a significant public health problem in our increasingly aging world. It is currently estimated that more than 200 million people worldwide are affected by osteoporosis. The most important clinical outcome of osteoporosis is fragility fractures that occur as a result of low-energy trauma.
Health literacy is an important determinant of both individual and public health and is considered a fundamental component of patient-centered care. Health literacy is defined as the ability to obtain, process, and understand relevant health information in order to make appropriate health decisions, and limited health literacy is recognized as a global public health problem. Many patients have difficulty understanding their medical conditions, medications, and care instructions due to inadequate health literacy. Patients with limited health literacy often have insufficient understanding of diagnostic and treatment protocols, which poses a risk for potential misuse of healthcare services and poorer health outcomes. Low levels of health literacy are also associated with increased hospital admissions and higher mortality rates. In contrast, higher health literacy is associated with greater health knowledge and self-confidence.
Screening for the prevention of osteoporosis and related fractures can reduce fracture-associated mortality and morbidity. Such screening may be initiated by physicians through the evaluation of osteoporosis risk factors during clinical visits, or in some cases, based on patient demand, again guided by the physician's assessment of risk factors. One of the most important factors influencing patient demand is the level of osteoporosis awareness. Early diagnosis and treatment in at-risk patient groups before fractures occur can help prevent potential complications.
In recent years, numerous scientific studies have investigated levels of osteoporosis knowledge and awareness. Some of these studies have focused on specific populations, such as individuals with spinal cord injury, rheumatoid arthritis, or patients followed after osteoporotic fractures, while others have been conducted exclusively among women.
With increasing life expectancy and the growth of the elderly population, osteoporosis has become a more prominent health issue and is no longer limited to postmenopausal women, but rather represents a serious health problem affecting individuals of both sexes.
The aim of the present study is to assess health literacy and the level of osteoporosis awareness among individuals in the age group at risk for osteoporosis and to identify factors influencing these outcomes. One of the distinguishing features of our study compared to previous research is the inclusion of both sexes. Another distinguishing aspect is the emphasis on the indication for osteoporosis screening in older adults, even in the absence of obvious risk factors such as chronic disease, medication use, or a history of fractures. We hope that our study will contribute to the existing literature on osteoporosis, health literacy, and osteoporosis awareness.
Health literacy is an important determinant of both individual and public health and is considered a fundamental component of patient-centered care. Health literacy is defined as the ability to obtain, process, and understand relevant health information in order to make appropriate health decisions, and limited health literacy is recognized as a global public health problem. Many patients have difficulty understanding their medical conditions, medications, and care instructions due to inadequate health literacy. Patients with limited health literacy often have insufficient understanding of diagnostic and treatment protocols, which poses a risk for potential misuse of healthcare services and poorer health outcomes. Low levels of health literacy are also associated with increased hospital admissions and higher mortality rates. In contrast, higher health literacy is associated with greater health knowledge and self-confidence.
Screening for the prevention of osteoporosis and related fractures can reduce fracture-associated mortality and morbidity. Such screening may be initiated by physicians through the evaluation of osteoporosis risk factors during clinical visits, or in some cases, based on patient demand, again guided by the physician's assessment of risk factors. One of the most important factors influencing patient demand is the level of osteoporosis awareness. Early diagnosis and treatment in at-risk patient groups before fractures occur can help prevent potential complications.
In recent years, numerous scientific studies have investigated levels of osteoporosis knowledge and awareness. Some of these studies have focused on specific populations, such as individuals with spinal cord injury, rheumatoid arthritis, or patients followed after osteoporotic fractures, while others have been conducted exclusively among women.
With increasing life expectancy and the growth of the elderly population, osteoporosis has become a more prominent health issue and is no longer limited to postmenopausal women, but rather represents a serious health problem affecting individuals of both sexes.
The aim of the present study is to assess health literacy and the level of osteoporosis awareness among individuals in the age group at risk for osteoporosis and to identify factors influencing these outcomes. One of the distinguishing features of our study compared to previous research is the inclusion of both sexes. Another distinguishing aspect is the emphasis on the indication for osteoporosis screening in older adults, even in the absence of obvious risk factors such as chronic disease, medication use, or a history of fractures. We hope that our study will contribute to the existing literature on osteoporosis, health literacy, and osteoporosis awareness.
Detailed Description:
Following approval from the institutional ethics committee, female patients aged 65 years and older and male patients aged 70 years and older who present to our outpatient clinic will be enrolled in the study. The study is designed as a cross-sectional study. All patients who apply to the Physical Medicine and Rehabilitation outpatient clinic and meet the inclusion criteria will be informed about the study, and those who provide written informed consent will be included. Participants' age, sex, and educational level will be recorded.
Health literacy will be assessed using the THLS-32 (Turkish Health Literacy Scale-32). The THLS-32 is a 32-item questionnaire that evaluates two domains (treatment and services; disease prevention/health promotion) and four processes (accessing health-related information, understanding health-related information, appraising health-related information, and applying/using health-related information). The Turkish validity and reliability of the Health Literacy Scale used in European countries were established in 2016, leading to the development of the THLS-32 scale. Each item is rated as very easy (1), easy (2), difficult (3), very difficult (4), or "I do not know" (5). The index score is calculated using the formula "index = (mean - 1) × (50/3)," resulting in a score range of 0-50. Cut-off values are defined as follows: 0-25 "inadequate health literacy," \>25-33 "problematic/limited health literacy," \>33-42 "adequate health literacy," and \>42-50 "excellent health literacy." In this survey, the minimum score is 0 and the maximum score is 50. Higher scores indicate higher health literacy levels.
Osteoporosis awareness will be evaluated using the "Osteoporosis Awareness Scale," which has demonstrated Turkish validity and reliability. The final Turkish version of the Osteoporosis Awareness Scale consists of 27 items and five subscales. The 27 items are rated on a 4-point Likert scale as follows: "I know very well" (4), "I know" (3), "I know a little" (2), and "I do not know at all" (1). The total score ranges from a minimum of 27 to a maximum of 108. Although the scale has no reverse-scored items or cut-off points, higher total scores indicate greater osteoporosis awareness. The subscales include Bone Physiology (items 22-27), Preventive Behaviors (items 4, 5, 7, 8, 9, 10, and 21), Risk Factors (items 11-15), Exercise (items 1, 2, 3, and 6), and Characteristics of Osteoporosis (items 16-20).
The collected data will be analyzed using an appropriate statistical software program.
No tests, laboratory examinations, or interventions will be performed as part of this study.
No specific safety precautions are required during the implementation of the study.
Inclusion Criteria
Female patients aged 65 years and older
Male patients aged 70 years and older
Exclusion Criteria
Cognitive dysfunction
Dementia
Uncontrolled psychiatric disorders
Adjustment disorders
Intellectual disability
Statistical Analysis
The collected data will be analyzed using SPSS version 25.0 (IBM SPSS Statistics 25 software; Armonk, NY: IBM Corp.). Continuous variables will be presented as mean ± standard deviation, and categorical variables as numbers and percentages. When parametric test assumptions are met, comparisons between independent groups will be performed using the independent samples t-test and one-way analysis of variance (ANOVA). When parametric assumptions are not met, the Mann-Whitney U test and Kruskal-Wallis test will be used. Differences between categorical variables will be examined using the chi-square test. Relationships between continuous variables will be analyzed using Spearman or Pearson correlation analyses, appropriate regression models, and differences between categorical variables will be assessed using chi-square analysis. Multivariate regression analysis is planned to evaluate the relationships between variables. A p-value \< 0.05 will be considered statistically significant.
At the beginning of the study, the sample size was calculated using the G\*Power 3.1.9 software. Based on reference studies, a moderate effect size of d = 0.63 was assumed, and a total sample size of at least 64 participants (32 women and 32 men) was determined.
Health literacy will be assessed using the THLS-32 (Turkish Health Literacy Scale-32). The THLS-32 is a 32-item questionnaire that evaluates two domains (treatment and services; disease prevention/health promotion) and four processes (accessing health-related information, understanding health-related information, appraising health-related information, and applying/using health-related information). The Turkish validity and reliability of the Health Literacy Scale used in European countries were established in 2016, leading to the development of the THLS-32 scale. Each item is rated as very easy (1), easy (2), difficult (3), very difficult (4), or "I do not know" (5). The index score is calculated using the formula "index = (mean - 1) × (50/3)," resulting in a score range of 0-50. Cut-off values are defined as follows: 0-25 "inadequate health literacy," \>25-33 "problematic/limited health literacy," \>33-42 "adequate health literacy," and \>42-50 "excellent health literacy." In this survey, the minimum score is 0 and the maximum score is 50. Higher scores indicate higher health literacy levels.
Osteoporosis awareness will be evaluated using the "Osteoporosis Awareness Scale," which has demonstrated Turkish validity and reliability. The final Turkish version of the Osteoporosis Awareness Scale consists of 27 items and five subscales. The 27 items are rated on a 4-point Likert scale as follows: "I know very well" (4), "I know" (3), "I know a little" (2), and "I do not know at all" (1). The total score ranges from a minimum of 27 to a maximum of 108. Although the scale has no reverse-scored items or cut-off points, higher total scores indicate greater osteoporosis awareness. The subscales include Bone Physiology (items 22-27), Preventive Behaviors (items 4, 5, 7, 8, 9, 10, and 21), Risk Factors (items 11-15), Exercise (items 1, 2, 3, and 6), and Characteristics of Osteoporosis (items 16-20).
The collected data will be analyzed using an appropriate statistical software program.
No tests, laboratory examinations, or interventions will be performed as part of this study.
No specific safety precautions are required during the implementation of the study.
Inclusion Criteria
Female patients aged 65 years and older
Male patients aged 70 years and older
Exclusion Criteria
Cognitive dysfunction
Dementia
Uncontrolled psychiatric disorders
Adjustment disorders
Intellectual disability
Statistical Analysis
The collected data will be analyzed using SPSS version 25.0 (IBM SPSS Statistics 25 software; Armonk, NY: IBM Corp.). Continuous variables will be presented as mean ± standard deviation, and categorical variables as numbers and percentages. When parametric test assumptions are met, comparisons between independent groups will be performed using the independent samples t-test and one-way analysis of variance (ANOVA). When parametric assumptions are not met, the Mann-Whitney U test and Kruskal-Wallis test will be used. Differences between categorical variables will be examined using the chi-square test. Relationships between continuous variables will be analyzed using Spearman or Pearson correlation analyses, appropriate regression models, and differences between categorical variables will be assessed using chi-square analysis. Multivariate regression analysis is planned to evaluate the relationships between variables. A p-value \< 0.05 will be considered statistically significant.
At the beginning of the study, the sample size was calculated using the G\*Power 3.1.9 software. Based on reference studies, a moderate effect size of d = 0.63 was assumed, and a total sample size of at least 64 participants (32 women and 32 men) was determined.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: