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

NCT ID: NCT05936177

Last Updated: 2023-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-08

Study Completion Date

2023-10-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Osteoporosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

PREVENTION

Blinding Strategy

NONE

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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Education Group

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.

Group Type OTHER

Patient education

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Not present

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Selkin Yılmaz Muluk

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Selkin Yılmaz Muluk

MD, Physical Therapy and Rehabilitation specialist

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Selkin Yılmaz

Role: PRINCIPAL_INVESTIGATOR

Antalya Ataturk Devlet Hastanesi

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Antalya, Muratpasa, Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 31828364 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24270886 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34773131 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28688497 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23878783 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23999904 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Informed Consent Form

View Document

Study Documents

Access uploaded study-related documents such as protocols, statistical analysis plans, or lay summaries.

Document Type: Health education concepts and strategies

View Document

Related Links

Access external resources that provide additional context or updates about the study.

https://www.osteoporosis.foundation/patients

The information presented in the PowerPoint slides has been derived from the 'International Osteoporosis Foundation' website.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

08.06.2023, no: 8/18

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Osteoporosis Awareness Among Nursing Students
NCT06760780 NOT_YET_RECRUITING NA