NCT05936177

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 8, 2023

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

June 17, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 7, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2023

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2023

Completed
Last Updated

October 17, 2023

Status Verified

October 1, 2023

Enrollment Period

4 months

First QC Date

June 17, 2023

Last Update Submit

October 16, 2023

Conditions

Osteoporosis

Keywords

osteoporosisawarenesseducationelderly

Outcome Measures

Primary Outcomes (1)

  • 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.

    Pre-education assessment (baseline) and immediate post-education assessment (short-term)

Secondary Outcomes (3)

  • Changes in participants' exercise habits.

    Pre-education assessment (baseline) and one month follow-up assessment (medium-term).

  • Changes in participants' dietary habits.

    Pre-education assessment (baseline) and one month follow-up assessment (medium-term).

  • Changes in participants' sun exposure habits.

    Pre-education assessment (baseline) and one month follow-up assessment (medium-term).

Study Arms (1)

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.

Other: Patient education

Interventions

Patient educationOTHER

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.

Also known as: Not present
Education Group

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Antalya, Muratpasa, 07160, Turkey (Türkiye)

Location

Related Publications (6)

  • 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.

    PMID: 31828364BACKGROUND

  • 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.

    PMID: 24270886BACKGROUND

  • 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.

    PMID: 34773131BACKGROUND

  • 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.

    PMID: 28688497BACKGROUND

  • 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.

    PMID: 23878783BACKGROUND

  • 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.

    PMID: 23999904BACKGROUND

Related Links

MeSH Terms

Conditions

Osteoporosis

Interventions

Patient Education as Topic

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Health EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Selkin Yılmaz

    Antalya Ataturk Devlet Hastanesi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
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.
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, Physical Therapy and Rehabilitation specialist

Study Record Dates

First Submitted

June 17, 2023

First Posted

July 7, 2023

Study Start

June 8, 2023

Primary Completion

September 29, 2023

Study Completion

October 15, 2023

Last Updated

October 17, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
October 2023-October 2024
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.

Available IPD Datasets

Health education concepts and strategies (World Health Organization)Access

Locations

TU(1)