Clinical trial NCT06134908: PRevention of OsTEoporotiC FracTure 2 Pilot Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fragility Fracture
Keywords: Osteoporosis
Fragility Fracture
Shared Decision-Making
Education
Lead sponsor: Third Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
Collaborators: name: Sir Run Run Shaw Hospital
name: The Second Affiliated Hospital of Hunan University of Chinese Medicine
name: Longgang Orthopedics Hospital of Shenzhen
name: The First People's Hospital of Hefei
name: Dongguan Eighth People's Hospital
name: The Third People's Hospital of Longgang District Shenzhen
First posted: 2023-11-18
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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 criteria: Inclusion Criteria:

1. Local residents (live in the city where the hospital is located for half a year or more);
2. Hospitalized patients with fractures aged 50 years and above;
3. First fracture, without history of fracture;
4. Never diagnosed as "osteoporosis" before admission;
5. No fracture history, and never receive any bone mineral density test, and never take anti-osteoporosis medication in the 4 years before admission;
6. Hospitalized patients with the following fractures: hip fracture, thoracic spine fracture, and lumbar spine fracture;
7. 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;
8. Not living in a nursing or rehabilitation institution before fracture;
9. Possess reading ability, and can read and understand informed consent forms or medical materials independently.

Exclusion Criteria:

1. Patients with pathological fractures caused by tumor or infection;
2. Patients with cognitive dysfunction or mental disorder;
3. AIDS patients;
4. Patients who refuse to follow-up, or have poor compliance for follow-up, or fail to understand and cooperate for follow-up;
5. Hearing or visual impairment, and unable to communicate or read materials;
6. Patients who have participate in other studies;
7. Other conditions that the investigator considered inappropriate to enroll.

Primary outcomes:
measure: Trial feasibility - Recruitment
timeFrame: 3 months
measure: Trial feasibility - Acceptability of the multicomponent program component
timeFrame: 30 days after study recruitment
measure: Trial feasibility - Acceptability of the shared decision-making process
timeFrame: 7 days after study recruitment
measure: Trial feasibility - Retention
timeFrame: 30 days after study recruitment
Secondary outcomes:
measure: Anti-osteoporosis treatment rate
timeFrame: 1 month follow-up; 3 month follow-up; 6 month follow-up; 12 month follow-up; 24 month follow-up
measure: Shared decision-making process
timeFrame: 7 days after study recruitment
measure: Bone mineral density test
timeFrame: 3 month follow-up; 6 month follow-up; 12 month follow-up; 24 month follow-up
measure: Adherence of anti-osteoporosis medication
timeFrame: 1 month follow-up; 3 month follow-up; 6 month follow-up; 12 month follow-up; 24 month follow-up
measure: Diagnosis, education, and follow-up practice of osteoporosis
timeFrame: 1 month follow-up; 3 month follow-up; 6 month follow-up; 12 month follow-up; 24 month follow-up
measure: Refracture
timeFrame: 1 month follow-up; 3 month follow-up; 6 month follow-up; 12 month follow-up; 24 month follow-up
measure: Survival
timeFrame: 1 month follow-up; 3 month follow-up; 6 month follow-up; 12 month follow-up; 24 month follow-up
measure: Patients' knowledge and attitude about osteoporosis and fragility fracture
timeFrame: baseline; 1 month follow-up; 6 month follow-up
Other outcomes:
Locations:
city: Changsha
country: China
facility: The Second Affiliated Hospital of Hunan University of Chinese Medicine
city: Dongguan
country: China
facility: Dongguan Eighth People's Hospital
city: Guangzhou
country: China
facility: Third Affiliated Hospital, Sun Yat-sen University
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
city: Hefei
country: China
facility: The First People's Hospital of Hefei
city: Shenzhen
country: China
facility: Longgang Orthopedics Hospital of Shenzhen
city: Shenzhen
country: China
facility: The Third People's Hospital of Longgang District Shenzhen
Study officials:
affiliation: Third Affiliated Hospital, Sun Yat-Sen University
name: Jian Mo, MD
role: PRINCIPAL_INVESTIGATOR
References: