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

Overview

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.

Interventions

• Behavioral Multifaceted Intervention
  The multicomponent intervention elements include education for clinicians and patients as well as a shared decision-making program among clinicians and patients. A shared decision-making booklet and a mobile application will be used to promote osteoporosis management and fracture practice.

Primary outcome measures

• Trial feasibility - Recruitment [Time frame: 3 months]
• Trial feasibility - Acceptability of the multicomponent program component [Time frame: 30 days after study recruitment]
• Trial feasibility - Acceptability of the shared decision-making process [Time frame: 7 days after study recruitment]
• Trial feasibility - Retention [Time frame: 30 days after study recruitment]

Secondary outcome measures (8)

• Anti-osteoporosis treatment rate [Time frame: 1 month follow-up; 3 month follow-up; 6 month follow-up; 12 month follow-up; 24 month follow-up]
• Shared decision-making process [Time frame: 7 days after study recruitment]
• Bone mineral density test [Time frame: 3 month follow-up; 6 month follow-up; 12 month follow-up; 24 month follow-up]
• Adherence of anti-osteoporosis medication [Time frame: 1 month follow-up; 3 month follow-up; 6 month follow-up; 12 month follow-up; 24 month follow-up]
• Diagnosis, education, and follow-up practice of osteoporosis [Time frame: 1 month follow-up; 3 month follow-up; 6 month follow-up; 12 month follow-up; 24 month follow-up]
• Refracture [Time frame: 1 month follow-up; 3 month follow-up; 6 month follow-up; 12 month follow-up; 24 month follow-up]
• Survival [Time frame: 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 [Time frame: baseline; 1 month follow-up; 6 month follow-up]

Eligibility criteria

Inclusion criteria

• 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 criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Health services research

Study locations

China · 7 centers

• The Second Affiliated Hospital of Hunan University of Chinese Medicine — Changsha
• Dongguan Eighth People's Hospital — Dongguan
• Third Affiliated Hospital, Sun Yat-sen University — Guangzhou
• Sir Run Run Shaw Hospital, Zhejiang University School of Medicine — Hangzhou
• The First People's Hospital of Hefei — Hefei
• Longgang Orthopedics Hospital of Shenzhen — Shenzhen
• The Third People's Hospital of Longgang District Shenzhen — Shenzhen

Identifiers

NCT: NCT06134908 · PROTECT-2 Pilot

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗