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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 7
- 主要终点
- Trial feasibility - Retention
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Patients with pathological fractures caused by tumor or infection;
- •Patients with cognitive dysfunction or mental disorder;
- •AIDS patients;
- •Patients who refuse to follow-up, or have poor compliance for follow-up, or fail to understand and cooperate for follow-up;
- •Hearing or visual impairment, and unable to communicate or read materials;
- •Patients who have participate in other studies;
- •Other conditions that the investigator considered inappropriate to enroll.
结局指标
主要结局
Trial feasibility - Retention
时间窗: 30 days after study recruitment
The retention rates will be assessed as the 30-day follow-up rate.
Trial feasibility - Recruitment
时间窗: 3 months
Number or N (%) participants recruited within 3 months of trial initiation at each centre.
Trial feasibility - Acceptability of the multicomponent program component
时间窗: 30 days after study recruitment
Participants will be asked to evaluate the program with a questionnaire with questions about frequency, length, content, delivery, and duration of the booklet and the mobile application using a 5-point Likert scale.
Trial feasibility - Acceptability of the shared decision-making process
时间窗: 7 days after study recruitment
Both clinicians and patients will be asked to evaluate the shared decision-making process once they completed it. A survey will be administered to evaluate the content and comprehension of the program using a 5-point Likert scale.
次要结局
- Shared decision-making process(7 days after study recruitment)
- Survival(1 month follow-up; 3 month follow-up; 6 month follow-up; 12 month follow-up; 24 month follow-up)
- Patients' knowledge and attitude about osteoporosis and fragility fracture(baseline; 1 month follow-up; 6 month follow-up)
- Refracture(1 month follow-up; 3 month follow-up; 6 month follow-up; 12 month follow-up; 24 month follow-up)
- Adherence of anti-osteoporosis medication(1 month follow-up; 3 month follow-up; 6 month follow-up; 12 month follow-up; 24 month follow-up)
- Anti-osteoporosis treatment rate(1 month follow-up; 3 month follow-up; 6 month follow-up; 12 month follow-up; 24 month follow-up)
- Bone mineral density test(3 month follow-up; 6 month follow-up; 12 month follow-up; 24 month follow-up)
- Diagnosis, education, and follow-up practice of osteoporosis(1 month follow-up; 3 month follow-up; 6 month follow-up; 12 month follow-up; 24 month follow-up)
研究者
Jian Mo
Principal Investigator
Third Affiliated Hospital, Sun Yat-Sen University