PRevention of OsTEoporotiC FracTure 2 Pilot Study

NCT ID: NCT06134908

Last Updated: 2024-05-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-13
• Study Completion Date: 2027-06-30

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.

Conditions

Fragility Fracture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Multifaceted Intervention

Intervention Type: BEHAVIORAL

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.

Usual-care Control

Group in the control arm will receive a leaflet and routine medical care per their existing health care providers.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sir Run Run Shaw Hospital

OTHER

Sponsor Role: collaborator

The Second Affiliated Hospital of Hunan University of Chinese Medicine

UNKNOWN

Sponsor Role: collaborator

Longgang Orthopedics Hospital of Shenzhen

UNKNOWN

Sponsor Role: collaborator

The First People's Hospital of Hefei

OTHER

Sponsor Role: collaborator

Dongguan Eighth People's Hospital

UNKNOWN

Sponsor Role: collaborator

The Third People's Hospital of Longgang District Shenzhen

UNKNOWN

Sponsor Role: collaborator

Third Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role: lead

Responsible Party

Jian Mo

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jian Mo, MD

Role: PRINCIPAL_INVESTIGATOR

Third Affiliated Hospital, Sun Yat-Sen University

Locations

The Second Affiliated Hospital of Hunan University of Chinese Medicine

Changsha, , China

Site Status: RECRUITING

Dongguan Eighth People's Hospital

Dongguan, , China

Site Status: RECRUITING

Third Affiliated Hospital, Sun Yat-sen University

Guangzhou, , China

Site Status: RECRUITING

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, , China

Site Status: RECRUITING

The First People's Hospital of Hefei

Hefei, , China

Site Status: RECRUITING

Longgang Orthopedics Hospital of Shenzhen

Shenzhen, , China

Site Status: RECRUITING

The Third People's Hospital of Longgang District Shenzhen

Shenzhen, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Jian Mo, MD

Role: CONTACT

mojian3@mail.sysu.edu.cn

+86 (020) 85252900

Facility Contacts

Jingqi Zeng, MD

Role: primary

Wenbo Cui, MD

Role: primary

Jian Mo, MD

Role: primary

mojian3@mail.sysu.edu.cn

+86 (020) 85252900

Shunwu Fan, MD

Role: primary

Zhou Dong, MD

Role: primary

Jie Li, MD

Role: primary

Shaomin Huang, MD

Role: primary

Other Identifiers

PROTECT-2 Pilot

Identifier Type: -

Identifier Source: org_study_id