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Brief Osteoporosis Education to Increase Awareness in Middle Aged and Elderly. (BOEIAMAE)

Primary Purpose

Osteoporosis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Patient education
Sponsored by
Selkin Yılmaz Muluk
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Osteoporosis focused on measuring osteoporosis, awareness, education, elderly

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Middle-aged and elderly individuals (e.g., 50 years and above). Ability to understand and communicate in the language of the study materials (Turkish). Willingness to participate in the study and provide informed consent. Residency in the community where the Elderly Houses are located (Muratpasa, Antalya). Availability to attend the education session and complete follow-up assessments. Exclusion Criteria: Severe cognitive impairments or mental health conditions that may hinder comprehension or participation. Pre-existing knowledge or educational background in osteoporosis, particularly through careers in health systems, that may bias the results. Participation in any other osteoporosis education programs within a specified period before the study. Inability to complete the questionnaire independently or engage in follow-up communication.

Sites / Locations

  • Elderly Homes (Fener, Soğuksu, Konuksever, Ciftekuyular Yaslı Evleri)

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Education Group

Arm Description

The Education Group arm will involve participants who receive the osteoporosis education intervention, which includes a concise educational session delivered by a physiatrist, covering various topics related to osteoporosis. Participants in this arm will have the opportunity to enhance their knowledge and awareness of osteoporosis through the provided educational materials and interactive discussions.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Changes in participants' exercise habits.
Does the education cause increase in participants' exercise routines?
Changes in participants' dietary habits.
Does the education cause increase in participants' calcium intake?
Changes in participants' sun exposure habits.
Does the education cause an increase in participants' duration of sun exposure?

Full Information

First Posted
June 17, 2023
Last Updated
October 16, 2023
Sponsor
Selkin Yılmaz Muluk
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1. Study Identification

Unique Protocol Identification Number
NCT05936177
Brief Title
Brief Osteoporosis Education to Increase Awareness in Middle Aged and Elderly.
Acronym
BOEIAMAE
Official Title
Effects of 20 Minutes Osteoporosis Education on the Awareness of Osteoporosis in People Registered in Elderly Care Homes
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
June 8, 2023 (Actual)
Primary Completion Date
September 29, 2023 (Actual)
Study Completion Date
October 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Selkin Yılmaz Muluk

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
osteoporosis, awareness, education, elderly

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Masking Description
The study does not involve masking for participants, investigator and assessors as the primary objective is to assess the impact of pre and post-education interventions on awareness scores, which are objective measures not subject to potential bias from knowledge of the intervention status.
Allocation
N/A
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Education Group
Arm Type
Other
Arm Description
The Education Group arm will involve participants who receive the osteoporosis education intervention, which includes a concise educational session delivered by a physiatrist, covering various topics related to osteoporosis. Participants in this arm will have the opportunity to enhance their knowledge and awareness of osteoporosis through the provided educational materials and interactive discussions.
Intervention Type
Other
Intervention Name(s)
Patient education
Other Intervention Name(s)
Not present
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in participants' knowledge about osteoporosis.
Description
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.
Time Frame
Pre-education assessment (baseline) and immediate post-education assessment (short-term)
Secondary Outcome Measure Information:
Title
Changes in participants' exercise habits.
Description
Does the education cause increase in participants' exercise routines?
Time Frame
Pre-education assessment (baseline) and one month follow-up assessment (medium-term).
Title
Changes in participants' dietary habits.
Description
Does the education cause increase in participants' calcium intake?
Time Frame
Pre-education assessment (baseline) and one month follow-up assessment (medium-term).
Title
Changes in participants' sun exposure habits.
Description
Does the education cause an increase in participants' duration of sun exposure?
Time Frame
Pre-education assessment (baseline) and one month follow-up assessment (medium-term).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Middle-aged and elderly individuals (e.g., 50 years and above). Ability to understand and communicate in the language of the study materials (Turkish). Willingness to participate in the study and provide informed consent. Residency in the community where the Elderly Houses are located (Muratpasa, Antalya). Availability to attend the education session and complete follow-up assessments. Exclusion Criteria: Severe cognitive impairments or mental health conditions that may hinder comprehension or participation. Pre-existing knowledge or educational background in osteoporosis, particularly through careers in health systems, that may bias the results. Participation in any other osteoporosis education programs within a specified period before the study. Inability to complete the questionnaire independently or engage in follow-up communication.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Selkin Yılmaz
Organizational Affiliation
Antalya Ataturk Devlet Hastanesi
Official's Role
Principal Investigator
Facility Information:
Facility Name
Elderly Homes (Fener, Soğuksu, Konuksever, Ciftekuyular Yaslı Evleri)
City
Antalya
State/Province
Muratpasa
ZIP/Postal Code
07160
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The IPD sharing plan for this osteoporosis education study prioritizes participant confidentiality and privacy. Therefore, the individual participant data will not be openly or publicly shared due to ethical considerations and the sensitive nature of the data. However, we support transparency and scientific collaboration. Upon request, deidentified aggregate data or summary statistics may be shared with qualified researchers for collaborative research, meta-analyses, or further exploration of study outcomes. Data sharing will comply with data protection regulations and guidelines. Requests for data access will be evaluated case-by-case by the principal investigator and research team, considering scientific validity, participant privacy protection, and ethical principles. Data access may require appropriate data sharing agreements and compliance with institutional and ethical review board policies.
IPD Sharing Time Frame
October 2023-October 2024
IPD Sharing Access Criteria
Access to the individual participant data (IPD) will be granted to qualified researchers or institutions engaged in scientific research or analysis related to osteoporosis education. Researchers must comply with ethical guidelines and data protection regulations. Researchers must sign a data use agreement and submit a research proposal outlining their study objectives and methodology. Access to the IPD will be subject to review and approval by an access committee or data sharing board. No data access fee will be charged.
Citations:
PubMed Identifier
31828364
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.
Results Reference
background
PubMed Identifier
24270886
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.
Results Reference
background
PubMed Identifier
34773131
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.
Results Reference
background
PubMed Identifier
28688497
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.
Results Reference
background
PubMed Identifier
23878783
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.
Results Reference
background
PubMed Identifier
23999904
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.
Results Reference
background
Links:
URL
https://www.osteoporosis.foundation/patients
Description
The information presented in the PowerPoint slides has been derived from the 'International Osteoporosis Foundation' website.
Available IPD and Supporting Information:
Available IPD/Information Type
Health education concepts and strategies
Available IPD/Information URL
https://apps.who.int/iris/bitstream/handle/10665/119953/EMRPUB_2012_EN_1362.pdf?sequence=1&isAllowed=y
Available IPD/Information Identifier
World Health Organization

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Brief Osteoporosis Education to Increase Awareness in Middle Aged and Elderly.

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