PRevention of OsTEoporotiC FracTure 2 Pilot Study

NCT06134908 | Recruiting

• 1 other identifier: PROTECT-2 Pilot
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 7

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

Keywords

Osteoporosis; Fragility Fracture; Shared Decision-Making; Education

Outcome Measures

Primary Outcomes (4)

• Trial feasibility - Recruitment

  Number or N (%) participants recruited within 3 months of trial initiation at each centre.

  3 months

• Trial feasibility - Acceptability of the multicomponent program component

  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.

  30 days after study recruitment

• Trial feasibility - Acceptability of the shared decision-making process

  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.

  7 days after study recruitment

• Trial feasibility - Retention

  The retention rates will be assessed as the 30-day follow-up rate.

  30 days after study recruitment

Secondary Outcomes (8)

• Anti-osteoporosis treatment rate

  1 month follow-up; 3 month follow-up; 6 month follow-up; 12 month follow-up; 24 month follow-up

• Shared decision-making process

  7 days after study recruitment

• Bone mineral density test

  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

• 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

Study Arms (2)

Multifaceted Intervention

EXPERIMENTAL

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.

Behavioral: Multifaceted Intervention

Usual-care Control

NO INTERVENTION

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

Interventions

Multifaceted Intervention 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.

Multifaceted Intervention

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Third Affiliated Hospital, Sun Yat-Sen University: lead
• Sir Run Run Shaw Hospital: collaborator
• The Second Affiliated Hospital of Hunan University of Chinese Medicine: collaborator
• Longgang Orthopedics Hospital of Shenzhen: collaborator
• The First People's Hospital of Hefei: collaborator
• Dongguan Eighth People's Hospital: collaborator
• The Third People's Hospital of Longgang District Shenzhen: collaborator

Study Sites (7)

The Second Affiliated Hospital of Hunan University of Chinese Medicine

Changsha, China

RECRUITING

Dongguan Eighth People's Hospital

Dongguan, China

RECRUITING

Third Affiliated Hospital, Sun Yat-sen University

Guangzhou, China

RECRUITING

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, China

RECRUITING

The First People's Hospital of Hefei

Hefei, China

RECRUITING

Longgang Orthopedics Hospital of Shenzhen

Shenzhen, China

RECRUITING

The Third People's Hospital of Longgang District Shenzhen

Shenzhen, China

RECRUITING

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Jian Mo, MD

  Third Affiliated Hospital, Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jian Mo, MD

CONTACT

+86 (020) 85252900; mojian3@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 11, 2023
• First Posted: November 18, 2023
• Study Start: January 13, 2024
• Primary Completion: June 1, 2025
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 28, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (7)