Health Literacy's Impact on Exercise Habits and Medication Adherence in Postmenopausal Osteoporosis

NCT06462833 | Recruiting

• 1 other identifier: GaziU HL EH MA PO
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Postmenopausal osteoporosis is characterized by low bone mass and increased fracture risk. Treatment includes exercise, nutrition, supplements, and medications like bisphosphonates, denosumab, or hormone replacement therapy. Lifestyle changes such as quitting smoking, reducing alcohol consumption, and preventing falls are also crucial. Despite effective treatments, adherence is low: 20-30% of patients don't start oral bisphosphonates, and 16-60% continue medications after one year. Exercise adherence rates are similarly low (14.3%-57.7%). This non-adherence imposes a significant clinical and economic burden. Health literacy (HL)-the ability to find, understand, and use health information-is vital for managing health but is understudied in relation to osteoporosis treatment adherence. This study aims to examine the relationship between HL, exercise habits, and medication adherence in postmenopausal osteoporosis patients. Understanding these factors can lead to effective interventions, improving patient adherence and health outcomes. The study will measure HL levels and their correlation with medication and exercise adherence, potentially informing health education programs and strategies to enhance treatment adherence. By doing so, it aims to improve health outcomes and healthcare system efficiency.

Conditions

Osteoporosis, Postmenopausal

Keywords

Health Literacy; Medication Adherence; Exercise; osteoporosis

Outcome Measures

Primary Outcomes (1)

• Health literacy

  Health literacy is the capacity of individuals to find, understand, evaluate, and apply health-related information to prevent diseases, develop healthy eating behaviors, and improve their health. The Turkish Health Literacy Scale-32 (THLS-32) will be used to assess the health literacy levels of the patients. THLS-32 is a 32-item Likert-type scale. Scores on the scale range from 0 indicating the lowest health literacy to 50 indicating the highest health literacy.

  Patients will be evaluated once in the baseline.

Secondary Outcomes (2)

• Medication adherence

  Patients will be evaluated once in the baseline.

• Physical activity

  Patients will be evaluated once in the baseline.

Study Arms (1)

postmenopausal osteoporosis

Patients followed in the Physical Medicine and Rehabilitation outpatient clinic with a diagnosis of postmenopausal osteoporosis.

Eligibility Criteria

• Age: 45 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who have been diagnosed with postmenopausal osteoporosis and treated in the outpatient clinic for at least one year will be included in the study. Every subject meeting the criteria of inclusion is going to be included into the study via consecutive participant sampling method.

You may qualify if:

• Postmenopausal patients
• Being under outpatient follow-up for osteoporosis for at least one year

You may not qualify if:

• Orthopedic, rheumatic, and neurological conditions that may hinder participation in exercise
• Cancer
• Refusal to participate in the study

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Gazi University

Ankara, Yenimahalle, 06560, Turkey (Türkiye)

RECRUITING

Related Publications (4)

• Hernlund E, Svedbom A, Ivergard M, Compston J, Cooper C, Stenmark J, McCloskey EV, Jonsson B, Kanis JA. Osteoporosis in the European Union: medical management, epidemiology and economic burden. A report prepared in collaboration with the International Osteoporosis Foundation (IOF) and the European Federation of Pharmaceutical Industry Associations (EFPIA). Arch Osteoporos. 2013;8(1):136. doi: 10.1007/s11657-013-0136-1. Epub 2013 Oct 11.

  PMID: 24113837 BACKGROUND

• Reynolds K, Muntner P, Cheetham TC, Harrison TN, Morisky DE, Silverman S, Gold DT, Vansomphone SS, Wei R, O'Malley CD. Primary non-adherence to bisphosphonates in an integrated healthcare setting. Osteoporos Int. 2013 Sep;24(9):2509-17. doi: 10.1007/s00198-013-2326-5. Epub 2013 Apr 18.

  PMID: 23595561 BACKGROUND

• Albrecht BM, Stalling I, Foettinger L, Recke C, Bammann K. Adherence to Lifestyle Recommendations for Bone Health in Older Adults with and without Osteoporosis: Cross-Sectional Results of the OUTDOOR ACTIVE Study. Nutrients. 2022 Jun 14;14(12):2463. doi: 10.3390/nu14122463.

  PMID: 35745193 BACKGROUND

• Roh YH, Koh YD, Noh JH, Gong HS, Baek GH. Effect of health literacy on adherence to osteoporosis treatment among patients with distal radius fracture. Arch Osteoporos. 2017 Dec;12(1):42. doi: 10.1007/s11657-017-0337-0. Epub 2017 Apr 18.

  PMID: 28421547 BACKGROUND

MeSH Terms

Conditions

Osteoporosis, Postmenopausal; Medication Adherence; Motor Activity; Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Ayça Utkan Karasu, MD

  Gazi University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ayça Utkan Karasu, MD

CONTACT

+905365759757; aycautkan@gazi.edu.tr

Levent Karataş, MD

CONTACT

+905055629437; dr.levent.karatas@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, Assistant Professor, Principal Investigator

Study Record Dates

• First Submitted: June 11, 2024
• First Posted: June 17, 2024
• Study Start: July 1, 2024
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: September 26, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)