OsteoporosisBOEIAMAENCT05936177
Brief Osteoporosis Education to Increase Awareness in Middle Aged and Elderly.
A study testing Patient education in people with Osteoporosis, run by Selkin Yılmaz Muluk at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 50 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Patient education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Jun 2023to 15 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Elderly Homes (Fener, Soğuksu, Konuksever, Ciftekuyular Yaslı Evleri)
Antalya, Muratpasa, 07160
About this study
Official title: Effects of 20 Minutes Osteoporosis Education on the Awareness of Osteoporosis in People Registered in Elderly Care Homes
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
Read the 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.
- Conditions
- Osteoporosis
- Being tested
- Patient education
- Keywords
- osteoporosis, awareness, education, elderly
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient educationOther
Also called Not present
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.
| Study group | Role | What they receive |
|---|---|---|
| Education Group | Other | 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. Receives: Other: Patient education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre-education assessment (baseline) and immediate post-education assessment (short-term)
Secondary outcomes (3)
Changes in participants' exercise habits.
Does the education cause increase in participants' exercise routines?
Measured: Pre-education assessment (baseline) and one month follow-up assessment (medium-term).
Changes in participants' dietary habits.
Does the education cause increase in participants' calcium intake?
Measured: Pre-education assessment (baseline) and one month follow-up assessment (medium-term).
Changes in participants' sun exposure habits.
Does the education cause an increase in participants' duration of sun exposure?
Measured: Pre-education assessment (baseline) and one month follow-up assessment (medium-term).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start8 Jun 2023
- Primary completion29 Sep 2023
- Study completion15 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selkin Yılmaz Muluk
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Selkin Yılmaz Muluk, Antalya Training and Research Hospital
- Investigators
- Selkin Yılmaz, Principal investigator, Antalya Ataturk Devlet Hastanesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05936177
- Sponsor's protocol ID
- 08.06.2023, no: 8/18
- Acronym
- BOEIAMAE
- Status last verified
- Oct 2023
- First submitted
- 17 Jun 2023
- Last updated
- 17 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 31828364Jensen 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.
PubMed 24270886Rubaek 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.
PubMed 34773131Kalkim 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.
PubMed 28688497Etemadifar 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.
PubMed 23878783Sayed-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.
PubMed 23999904
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of 20 Minutes Osteoporosis Education on the Awareness of Osteoporosis in People Registered in Elderly Care Homes
- ClinicalTrials.gov ID
- NCT05936177
- Acronym / sponsor ID
- BOEIAMAE / 08.06.2023, no: 8/18
- Conditions
- Osteoporosis
- Keywords
- osteoporosis, awareness, education, elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Selkin Yılmaz MulukOther government
- Study start
- 8 Jun 2023 (actual)
- Primary completion
- 29 Sep 2023 (actual)
- Study completion
- 15 Oct 2023 (actual)
- First posted
- 7 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Education Group | Other | Other: Patient educationThe 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. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient educationAlso: Not presentThe 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. | Other | Education Group |
Primary outcome
Change in participants' knowledge about osteoporosis.
Time frame: Pre-education assessment (baseline) and immediate post-education assessment (short-term)
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.
3 secondary outcomes
Changes in participants' exercise habits.
Time frame: Pre-education assessment (baseline) and one month follow-up assessment (medium-term).
Changes in participants' dietary habits.
Time frame: Pre-education assessment (baseline) and one month follow-up assessment (medium-term).
Changes in participants' sun exposure habits.
Time frame: Pre-education assessment (baseline) and one month follow-up assessment (medium-term).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2023.
- Background: PubMed 31828364Gai 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.
- Background: PubMed 24270886Jensen 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.
- Background: PubMed 34773131Rubaek 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.
- Background: PubMed 28688497Kalkim 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.
- Background: PubMed 23878783Etemadifar 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.
- Background: PubMed 23999904Sayed-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.
- The information presented in the PowerPoint slides has been derived from the 'International Osteoporosis Foundation' website.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Selkin Yılmaz principal investigator
Antalya Ataturk Devlet Hastanesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient education in people with Osteoporosis, run by Selkin Yılmaz Muluk at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in participants' knowledge about osteoporosis. (time frame: Pre-education assessment (baseline) and immediate post-education assessment (short-term)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05936177, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2023.