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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
Led by Third Affiliated Hospital, Sun Yat-Sen University · Updated on 2024-05-28
50
Participants Needed
7
Research Sites
104 weeks
Total Duration
On this page
Sponsors
T
Third Affiliated Hospital, Sun Yat-Sen University
Lead Sponsor
S
Sir Run Run Shaw Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Fragility fractures and osteoporosis are increasing health concerns, especially among people aged 50 and older in China, where the aging population is rapidly growing. This research aims to test a program called "Precise Education + Shared Decision-Making" designed to help patients with fragility fractures actively participate in their osteoporosis management to prevent further fractures. The study is a pilot cluster randomized controlled trial conducted in several hospitals to assess the program's acceptability, feasibility, and preliminary effectiveness. Participants are divided into two groups. One group receives a multifaceted intervention that includes education for both clinicians and patients, a shared decision-making booklet, and a mobile app to promote better osteoporosis management and fracture care. The control group receives usual medical care along with a leaflet. The study follows participants over time to observe how these different approaches impact treatment and fracture prevention. During the study, participants will be monitored for recruitment success, retention, and how acceptable they find the program and shared decision-making process. Researchers will also track osteoporosis treatment rates, medication adherence, bone density tests, refracture occurrences, and patient knowledge at multiple follow-ups ranging from one month to two years. This thorough monitoring helps evaluate how well the program supports ongoing osteoporosis care and fracture prevention.
CONDITIONS
Brief Title
PRevention of OsTEoporotiC FracTure 2 Pilot Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Local residents living in the city where the hospital is located for six months or more
- Hospitalized patients aged 50 years and above with fractures
- First fracture with no previous fracture history
- No prior diagnosis of osteoporosis before admission
- No fracture history, no bone mineral density tests, and no anti-osteoporosis medication in the past 4 years
- Fractures of the hip, thoracic spine, or lumbar spine
- New fragility fracture caused by minor trauma or daily activities within the past 6 weeks
- Not living in a nursing or rehabilitation institution before the fracture
- Able to read and understand informed consent and medical materials independently
You will not qualify if you...
- Pathological fractures caused by tumor or infection
- Cognitive dysfunction or mental disorders
- AIDS patients
- Refusal or poor compliance for follow-up or inability to cooperate
- Hearing or visual impairment preventing communication or reading
- Participation in other studies
- Any other condition deemed inappropriate by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months
Participants receive a multicomponent behavioral intervention including education and shared decision-making tools to promote osteoporosis management and fracture prevention, or receive routine medical care and educational leaflets.
Visits at baseline, 1 month, 3 months, 6 months, 12 months, and 24 months
Trial Site Locations
Total: 7 locations
1
The Second Affiliated Hospital of Hunan University of Chinese Medicine
Changsha, China
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2
Dongguan Eighth People's Hospital
Dongguan, China
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3
Third Affiliated Hospital, Sun Yat-sen University
Guangzhou, China
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4
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, China
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5
The First People's Hospital of Hefei
Hefei, China
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6
Longgang Orthopedics Hospital of Shenzhen
Shenzhen, China
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7
The Third People's Hospital of Longgang District Shenzhen
Shenzhen, China
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Research Team
J
Jian Mo, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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