Clinical trial NCT05936177: Brief Osteoporosis Education to Increase Awareness in Middle Aged and Elderly.
Official title: Effects of 20 Minutes Osteoporosis Education on the Awareness of Osteoporosis in People Registered in Elderly Care Homes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporosis
Keywords: osteoporosis
awareness
education
elderly
Lead sponsor: Antalya Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2023-07-07
Enrollment: 76
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: In this study, we plan to employ a statistical model as its primary framework for evaluation and analysis. The main focus of the study will center around the statistical modeling of data collected through pre and post-education questionnaires, as well as the demographic information of the participants and changes in their lifestyle habits. The study design will include cluster randomization, wherein two out of the four elderly homes in our municipality will be randomly selected using a simple random sampling technique (via coin toss) to be part of the study. Participants attending to these selected houses will be recruited as volunteers through short message service (SMS) invitations. This approach will enable us to examine and analyze the impact of the education intervention on participants' knowledge levels, as well as their potential shifts in lifestyle choices.
Primary purpose: PREVENTION

Brief 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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in participants' knowledge about osteoporosis.
timeFrame: Pre-education assessment (baseline) and immediate post-education assessment (short-term)
Secondary outcomes:
measure: Changes in participants' exercise habits.
timeFrame: Pre-education assessment (baseline) and one month follow-up assessment (medium-term).
measure: Changes in participants' dietary habits.
timeFrame: Pre-education assessment (baseline) and one month follow-up assessment (medium-term).
measure: Changes in participants' sun exposure habits.
timeFrame: Pre-education assessment (baseline) and one month follow-up assessment (medium-term).
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Elderly Homes (Fener, Soğuksu, Konuksever, Ciftekuyular Yaslı Evleri)
state: Muratpasa
Study officials:
affiliation: Antalya Ataturk Devlet Hastanesi
name: Selkin Yılmaz
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
citation: 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.
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.