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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05936177
Other study ID # 08.06.2023, no: 8/18
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 8, 2023
Est. completion date October 15, 2023

Study information

Verified date October 2023
Source Antalya Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Osteoporosis is a growing global concern, particularly as the population of middle-aged and elderly individuals continues to rise within communities. This demographic, being more susceptible to chronic diseases, poses a burden on healthcare systems. The objective of this study is to explore methods of educating middle-aged and elderly individuals about osteoporosis, aiming to raise awareness of the disease and promote informed decision-making regarding prevention and treatment options


Description:

This research will involve visiting all four Elderly Houses in Muratpasa, Antalya. After obtaining informed consent, participants will be asked to provide demographic information, including age, sex, and education levels, as well as relevant medical history, such as family history of osteoporosis. Additionally, participants will complete a validated questionnaire called the Osteoporosis Knowledge Assessment Tool (OKAT). Those who express interest in further education will be enrolled in an osteoporosis education program, which will be scheduled accordingly. The education program will utilize slides prepared based on information from the International Osteoporosis Foundation website (http://www.osteoporosis.foundation) and the WHO health education booklet. Delivered by a physiatrist, the education session will be concise, lasting approximately 20 minutes, and will cover various topics, including the definition of osteoporosis, its causes, risks, complications, dietary options, and specific exercise recommendations. Following the education session, participants will once again complete the OKAT questionnaire to assess any changes in knowledge. They will also have the opportunity to have their questions addressed. One month later, participants will be contacted by phone for a follow-up interview, during which changes in their dietary habits, sun exposure, exercise routines, and other relevant factors will be discussed. Lastly, participants will complete the OKAT questionnaire for the third time. These measures will help evaluate the effectiveness of the osteoporosis education intervention and provide insights into any potential changes in participants' knowledge and behavior over time.


Recruitment information / eligibility

Status Completed
Enrollment 76
Est. completion date October 15, 2023
Est. primary completion date September 29, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years to 90 Years
Eligibility Inclusion Criteria: 1. Middle-aged and elderly individuals (e.g., 50 years and above). 2. Ability to understand and communicate in the language of the study materials (Turkish). 3. Willingness to participate in the study and provide informed consent. 4. Residency in the community where the Elderly Houses are located (Muratpasa, Antalya). 5. Availability to attend the education session and complete follow-up assessments. Exclusion Criteria: 1. Severe cognitive impairments or mental health conditions that may hinder comprehension or participation. 2. Pre-existing knowledge or educational background in osteoporosis, particularly through careers in health systems, that may bias the results. 3. Participation in any other osteoporosis education programs within a specified period before the study. 4. Inability to complete the questionnaire independently or engage in follow-up communication.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Patient education
The intervention in this osteoporosis education research will consist of a concise and informative educational session delivered by a physiatrist, utilizing slides prepared based on information from reputable sources such as the International Osteoporosis Foundation website and the World Health Organization (WHO) health education booklet. The session will cover various topics including the definition of osteoporosis, its causes, risks, complications, dietary options, and specific exercise recommendations, with a focus on raising awareness and promoting informed decision-making regarding prevention and treatment options.

Locations

Country Name City State
Turkey Elderly Homes (Fener, Soguksu, Konuksever, Ciftekuyular Yasli Evleri) Antalya Muratpasa

Sponsors (1)

Lead Sponsor Collaborator
Selkin Yilmaz Muluk

Country where clinical trial is conducted

Turkey, 

References & Publications (6)

Etemadifar MR, Nourian SM, Fereidan-Esfahani M, Shemshaki H, Nourbakhsh M, Zarezadeh A. Relationship of knowledge about osteoporosis with education level and life habits. World J Orthop. 2013 Jul 18;4(3):139-43. doi: 10.5312/wjo.v4.i3.139. Print 2013 Jul 18. — View Citation

Gai QY, Lv H, Li YP, Fu QM, Li P. Education intervention for older adults with osteoporosis: a systematic review. Osteoporos Int. 2020 Apr;31(4):625-635. doi: 10.1007/s00198-019-05166-5. Epub 2019 Dec 11. — View Citation

Jensen AL, Lomborg K, Wind G, Langdahl BL. Effectiveness and characteristics of multifaceted osteoporosis group education--a systematic review. Osteoporos Int. 2014 Apr;25(4):1209-24. doi: 10.1007/s00198-013-2573-5. Epub 2013 Nov 23. — View Citation

Kalkim A, Daghan S. Theory-based Osteoporosis Prevention Education and Counseling Program for Women: A Randomized Controlled Trial. Asian Nurs Res (Korean Soc Nurs Sci). 2017 Jun;11(2):119-127. doi: 10.1016/j.anr.2017.05.010. Epub 2017 Jun 28. — View Citation

Rubaek M, Hitz MF, Holmberg T, Schonwandt BMT, Andersen S. Effectiveness of patient education for patients with osteoporosis: a systematic review. Osteoporos Int. 2022 May;33(5):959-977. doi: 10.1007/s00198-021-06226-5. Epub 2021 Nov 12. — View Citation

Sayed-Hassan R, Bashour H, Koudsi A. Osteoporosis knowledge and attitudes: a cross-sectional study among female nursing school students in Damascus. Arch Osteoporos. 2013;8:149. doi: 10.1007/s11657-013-0149-9. Epub 2013 Sep 3. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in participants' knowledge about osteoporosis. Change in participants' knowledge about osteoporosis before and after the education. This can be assessed using the Osteoporosis Knowledge Assessment Tool. Each correct answer receives 1 point, and incorrect or unknown answers receive 0 points, resulting in scores ranging from 0 to 20, based on this 20-question questionnaire. High scores mean a better awareness. Pre-education assessment (baseline) and immediate post-education assessment (short-term)
Secondary Changes in participants' exercise habits. Does the education cause increase in participants' exercise routines? Pre-education assessment (baseline) and one month follow-up assessment (medium-term).
Secondary Changes in participants' dietary habits. Does the education cause increase in participants' calcium intake? Pre-education assessment (baseline) and one month follow-up assessment (medium-term).
Secondary Changes in participants' sun exposure habits. Does the education cause an increase in participants' duration of sun exposure? Pre-education assessment (baseline) and one month follow-up assessment (medium-term).
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