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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010024', 'term': 'Osteoporosis'}], 'ancestors': [{'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 190}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-03-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-11', 'studyFirstSubmitDate': '2026-01-24', 'studyFirstSubmitQcDate': '2026-02-11', 'lastUpdatePostDateStruct': {'date': '2026-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'THLS-32 (Turkish Health Literacy Scale-32)', 'timeFrame': '6 months', 'description': 'THLS-32 (Turkish Health Literacy Scale-32) for health literacy. In this survey, the minimum score is 0 and the maximum score is 50. Higher scores indicate higher health literacy levels.'}, {'measure': 'Osteoporosis Awareness Scale', 'timeFrame': '6 months', 'description': '"Osteoporosis Awareness Scale" for osteoporosis awareness. 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.'}], 'secondaryOutcomes': [{'measure': 'Relationship between age and THSL-32', 'timeFrame': '6 months', 'description': '-Relationship between age and THSL-32'}, {'measure': '-Relationship between age and the "Osteoporosis Awareness Scale"', 'timeFrame': '6 months', 'description': '-Relationship between age and the "Osteoporosis Awareness Scale"'}, {'measure': '-Relationship between gender and THSL-32', 'timeFrame': '6 months', 'description': 'Relationship between gender and THSL-32'}, {'measure': '-Relationship between gender and the "Osteoporosis Awareness Scale"', 'timeFrame': '6 months', 'description': '-Relationship between gender and the "Osteoporosis Awareness Scale"'}, {'measure': '-Relationship between education level and THSL-32', 'timeFrame': '6 months', 'description': '-Relationship between education level and THSL-32'}, {'measure': 'Relationship between education level and the "Osteoporosis Awareness Scale"', 'timeFrame': '6 months', 'description': 'Relationship between education level and the "Osteoporosis Awareness Scale"'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['osteoporosis', 'health literacy', 'awareness'], 'conditions': ['Osteoporosis', 'Health Literacy Level', 'Awareness and Knowledge Level']}, 'referencesModule': {'references': [{'pmid': '20940232', 'type': 'BACKGROUND', 'citation': 'Papaioannou A, Morin S, Cheung AM, Atkinson S, Brown JP, Feldman S, Hanley DA, Hodsman A, Jamal SA, Kaiser SM, Kvern B, Siminoski K, Leslie WD; Scientific Advisory Council of Osteoporosis Canada. 2010 clinical practice guidelines for the diagnosis and management of osteoporosis in Canada: summary. CMAJ. 2010 Nov 23;182(17):1864-73. doi: 10.1503/cmaj.100771. Epub 2010 Oct 12. No abstract available.'}, {'pmid': '1421796', 'type': 'BACKGROUND', 'citation': 'Cooper C, Campion G, Melton LJ 3rd. Hip fractures in the elderly: a world-wide projection. Osteoporos Int. 1992 Nov;2(6):285-9. doi: 10.1007/BF01623184.'}, {'pmid': '25182228', 'type': 'BACKGROUND', 'citation': "Cosman F, de Beur SJ, LeBoff MS, Lewiecki EM, Tanner B, Randall S, Lindsay R; National Osteoporosis Foundation. Clinician's Guide to Prevention and Treatment of Osteoporosis. Osteoporos Int. 2014 Oct;25(10):2359-81. doi: 10.1007/s00198-014-2794-2. Epub 2014 Aug 15."}], 'seeAlsoLinks': [{'url': 'https://www.annualreviews.org/doi/10.1146/annurev-publhealth-090419-102529', 'label': 'recommendation'}]}, 'descriptionModule': {'briefSummary': "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.\n\nHealth 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.\n\nScreening 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.\n\nIn 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.\n\nWith 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.\n\nThe 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.", 'detailedDescription': '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.\n\nHealth 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.\n\nOsteoporosis 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).\n\nThe collected data will be analyzed using an appropriate statistical software program.\n\nNo tests, laboratory examinations, or interventions will be performed as part of this study.\n\nNo specific safety precautions are required during the implementation of the study.\n\nInclusion Criteria\n\nFemale patients aged 65 years and older\n\nMale patients aged 70 years and older\n\nExclusion Criteria\n\nCognitive dysfunction\n\nDementia\n\nUncontrolled psychiatric disorders\n\nAdjustment disorders\n\nIntellectual disability\n\nStatistical Analysis\n\nThe 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.\n\nAt 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female patients aged 65 years and older\n* Male patients aged 70 years and older\n\nExclusion Criteria:\n\n* Cognitive dysfunction\n* Dementia\n* Uncontrolled psychiatric disorders\n* Adjustment disorders\n* Intellectual disability'}, 'identificationModule': {'nctId': 'NCT07419451', 'briefTitle': 'Health Literacy and Osteoporosis Awareness', 'organization': {'class': 'OTHER', 'fullName': 'Bandırma Onyedi Eylül University'}, 'officialTitle': 'Health Literacy and Osteoporosis Awareness Levels Among Individuals in the Age Group at Risk for Osteoporosis: A Descriptive Cross-Sectional Study', 'orgStudyIdInfo': {'id': 'E-67961857-050.04-2500024943'}}, 'armsInterventionsModule': {'armGroups': [{'label': '95 men and 95 women', 'description': 'equal number of patients of both sexes', 'interventionNames': ['Other: Patients will only fill out a questionnaire.']}], 'interventions': [{'name': 'Patients will only fill out a questionnaire.', 'type': 'OTHER', 'description': 'Health literacy will be assessed using the TSOY-32 (Turkish Health Literacy Scale-32). The TSOY-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 by Okyay and Abacıgil, leading to the development of the TSOY-32 scale (12). 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 healt', 'armGroupLabels': ['95 men and 95 women']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10200', 'city': 'Balıkesir', 'state': 'Bandırma', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Ayşe Güldem Kilciler, Prof. Dr.', 'role': 'CONTACT', 'email': 'akilciler@bandirma.edu.tr', 'phone': '+9 0266 717 01 17'}, {'name': 'Nurten Nas Kırdar, Dr. Öğr. Üyesi', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Bandırma Onyedi Eylul University Faculty of Medicine', 'geoPoint': {'lat': 39.64917, 'lon': 27.88611}}], 'centralContacts': [{'name': 'Nurten NAS KIRDAR, Dr. Öğr. Üyesi', 'role': 'CONTACT', 'email': 'nkirdar@bandirma.edu.tr', 'phone': '+905415511691'}, {'name': 'Naime Meriç KONAR EROL, Associate Professor', 'role': 'CONTACT', 'email': 'mkonar@bandirma.edu.tr'}], 'overallOfficials': [{'name': 'Nurten Nas Kırdar, Dr. Öğr. Üyesi', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bandırma Onyedi Eylül University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The data analysis and results of our scientific research have not yet been completed. The final version of our study will be shared with readers by being published in an academic journal in the field of medicine. If a suitable journal deems our study suitable for publication after the peer review process, other researchers will be able to read and benefit from this publication once it is released.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bandırma Onyedi Eylül University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Nurten NAS KIRDAR', 'investigatorAffiliation': 'Bandırma Onyedi Eylül University'}}}}