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

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
The Second Affiliated Hospital of Hunan University of Chinese Medicine
RECRUITING
Changsha
Dongguan Eighth People's Hospital
RECRUITING
Dongguan
Third Affiliated Hospital, Sun Yat-sen University
RECRUITING
Guangzhou
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
RECRUITING
Hangzhou
The First People's Hospital of Hefei
RECRUITING
Hefei
Longgang Orthopedics Hospital of Shenzhen
RECRUITING
Shenzhen
The Third People's Hospital of Longgang District Shenzhen
RECRUITING
Shenzhen
Contact Information
Primary
Jian Mo, MD
mojian3@mail.sysu.edu.cn
+86 (020) 85252900
Time Frame
Start Date: 2024-01-13
Estimated Completion Date: 2027-06
Participants
Target number of participants: 50
Treatments
Experimental: Multifaceted Intervention
Group in the intervention arm will receive a multicomponent intervention at the clinician- and patient-level, with a shared decision-making booklet as well as a mobile application to promote osteoporosis management and fracture practice.
No_intervention: Usual-care Control
Group in the control arm will receive a leaflet and routine medical care per their existing health care providers.
Related Therapeutic Areas
Sponsors
Collaborators: The Third People's Hospital of Longgang District Shenzhen, The Second Affiliated Hospital of Hunan University of Chinese Medicine, The First People's Hospital of Hefei, Dongguan Eighth People's Hospital, Longgang Orthopedics Hospital of Shenzhen, Sir Run Run Shaw Hospital
Leads: Third Affiliated Hospital, Sun Yat-Sen University

This content was sourced from clinicaltrials.gov