Tests an education and shared decision program for people with fragility fractures
Tests a education and decision-support program to prevent repeat fractures in adults with fragility fractures.
Plain-language title generated from the registry record
Registry title: PRevention of OsTEoporotiC FracTure 2 Pilot Study
Key facts
- Where
- Changsha, Dongguan, Guangzhou, Hangzhou, Hefei, and Shenzhen, ChinaSee the 7 sites
Where in China
- The Second Affiliated Hospital of Hunan University of Chinese MedicineChangsha, ChinaTaking people
- Dongguan Eighth People's HospitalDongguan, ChinaTaking people
- Third Affiliated Hospital, Sun Yat-sen UniversityGuangzhou, ChinaTaking people
- Sir Run Run Shaw Hospital Zhejiang University School of MedicineHangzhou, ChinaTaking people
- The First People's Hospital of HefeiHefei, ChinaTaking people
- Longgang Orthopedics Hospital of ShenzhenShenzhen, ChinaTaking people
- The Third People's Hospital of Longgang District ShenzhenShenzhen, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Third Affiliated Hospital, Sun Yat-Sen University
- Trial code
- NCT06134908
- Record updated
- 28 May 2024
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: Local residents (live in the city where the hospital is located for half a year or more); Hospitalized patients with fractures aged 50 years and above; First fracture, without history of fracture; Never diagnosed as "osteoporosis" before admission; No fracture history, and never receive any bone mineral density test, and never take anti-osteoporosis medication in the 4 years before admission; Hospitalized patients with the following fractures: hip fracture, thoracic spine fracture, and lumbar spine fracture; New fragility fracture: fracture that occurs after minor trauma or daily activities, such as a fracture caused by a fall from standing height or less; fracture happened within 6 weeks; Not living in a nursing or rehabilitation institution before fracture; Possess reading ability, and can read and understand informed consent forms or medical materials independently.
Exclusion: Patients with pathological fractures caused by tumor or infection; Patients with cognitive dysfunction or mental disorder; Hearing or visual impairment, and unable to communicate or read materials; Other conditions that the investigator considered inappropriate to enroll; AIDS patients; Patients who refuse to follow-up, or have poor compliance for follow-up, or fail to understand and cooperate for follow-up; Patients who have participate in other studies.