RecruitingNot ApplicableNCT06134908

PRevention of OsTEoporotiC FracTure 2 Pilot Study

The Application of "Precise Education + Shared Decision-Making" Program for the Secondary Prevention of Fragility Fractures Based on Behavioral Theories: A Pilot Cluster Randomized Controlled Trial


Sponsor

Third Affiliated Hospital, Sun Yat-Sen University

Enrollment

50 participants

Start Date

Jan 13, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

With the aging of the world population, osteoporosis and fragility fractures have become global public health concerns. It has been estimated the population of people ≥60 years of age will increase from 229 million (16.2%) in 2017 to 479 million (35.1%) by 2050 in China. Because age is an important predictor of osteoporosis and fragility fracture, the incidence of fragility fracture has increased dramatically in China over the past decades. Timely treatment of osteoporosis is an effective way to decrease additional fracture risk among patients with fragility fractures, but anti-osteoporosis treatment rate is relatively low in China. Effective fracture prevention intervention is urgently needed in China. As a potential way to achieve effective risk communication, shared decision-making allows patients to be active participants in the management of osteoporosis. The investigators designed a multifaceted intervention, which was named as "Precise Education + Shared Decision-Making" program for the secondary prevention of fragility fractures based on behavioral theories, and assessed the effectiveness for fracture prevention using a pilot cluster randomized controlled trial among several hospitals in China. The aim of this pilot study is to test the acceptability and feasibility as well as preliminary efficacy of this program in patients with fragility fractures.


Eligibility

Min Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a behavioral approach called Multifaceted Intervention for people with fragility fracture. The study is currently recruiting participants at 7 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALMultifaceted Intervention

The multicomponent intervention elements include education for clinicians and patients as well as a shared decision-making program among clinicians and patients. A shared decision-making booklet and a mobile application will be used to promote osteoporosis management and fracture practice.


Locations(7)

The Second Affiliated Hospital of Hunan University of Chinese Medicine

Changsha, China

Dongguan Eighth People's Hospital

Dongguan, China

Third Affiliated Hospital, Sun Yat-sen University

Guangzhou, China

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, China

The First People's Hospital of Hefei

Hefei, China

Longgang Orthopedics Hospital of Shenzhen

Shenzhen, China

The Third People's Hospital of Longgang District Shenzhen

Shenzhen, China

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NCT06134908


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