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

October 16, 2023 updated by: Selkin Yılmaz Muluk

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

76

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Muratpasa
      • Antalya, Muratpasa, Turkey, 07160
        • Elderly Homes (Fener, Soğuksu, Konuksever, Ciftekuyular Yaslı Evleri)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
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.
Other Names:
  • Not present

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Pre-education assessment (baseline) and immediate post-education assessment (short-term)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in participants' exercise habits.
Time Frame: Pre-education assessment (baseline) and one month follow-up assessment (medium-term).
Does the education cause increase in participants' exercise routines?
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).
Does the education cause increase in participants' calcium intake?
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).
Does the education cause an increase in participants' duration of sun exposure?
Pre-education assessment (baseline) and one month follow-up assessment (medium-term).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Selkin Yılmaz Muluk

Investigators

  • Principal Investigator: Selkin Yılmaz, Antalya Ataturk Devlet Hastanesi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 8, 2023

Primary Completion (Actual)

September 29, 2023

Study Completion (Actual)

October 15, 2023

Study Registration Dates

First Submitted

June 17, 2023

First Submitted That Met QC Criteria

July 6, 2023

First Posted (Actual)

July 7, 2023

Study Record Updates

Last Update Posted (Actual)

October 17, 2023

Last Update Submitted That Met QC Criteria

October 16, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08.06.2023, no: 8/18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Study Data/Documents

  1. Health education concepts and strategies
    Information identifier: World Health Organization

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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