PRevention of OsTEoporotiC FracTure 2 Pilot Study (PROTECT-2)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Fragility Fracture
• Intervention / Treatment: Behavioral: Multifaceted Intervention

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jian Mo, MD; Phone Number: +86 (020) 85252900; Email: mojian3@mail.sysu.edu.cn

Study Locations

• China
  • Guangzhou, China
    • Recruiting
    • Third Affiliated Hospital, Sun Yat-Sen University
    • Contact: Jian Mo, MD; Phone Number: +86 (020) 85252900; Email: mojian3@mail.sysu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
No Intervention: Usual-care Control; Group in the control arm will receive a leaflet and routine medical care per their existing health care providers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anti-osteoporosis treatment rate	The patients will be followed up and asked whether they accept any anti-osteoporosis medication.	1 month follow-up; 3 month follow-up; 6 month follow-up; 12 month follow-up; 24 month follow-up
Shared decision-making process	Standardized questionnaires will be used to evaluated the shared decision-making process.	7 days after study recruitment
Bone mineral density test	The patients will be followed up and asked whether they accept 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	Adherence of anti-osteoporosis medication will be assessed with medication possession ratio and self-reported question.	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	The patients will be followed up with questionnaires about diagnosis, education, and follow-up of osteoporosis.	1 month follow-up; 3 month follow-up; 6 month follow-up; 12 month follow-up; 24 month follow-up
Refracture	The patients will be followed up and asked whether they have refracture.	1 month follow-up; 3 month follow-up; 6 month follow-up; 12 month follow-up; 24 month follow-up
Survival	The patients will be followed up about their survival status.	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	Patients' knowledge and attitude about osteoporosis and fragility fracture will be evaluated with standardized questionnaires.	baseline; 1 month follow-up; 6 month follow-up

Collaborators and Investigators

• Sponsor: Third Affiliated Hospital, Sun Yat-Sen University
• Investigators: Principal Investigator: Jian Mo, MD, Third Affiliated Hospital, Sun Yat-Sen University

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2023
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: November 11, 2023
• First Submitted That Met QC Criteria: November 11, 2023
• First Posted (Estimated): November 16, 2023

Study Record Updates

• Last Update Posted (Estimated): November 16, 2023
• Last Update Submitted That Met QC Criteria: November 11, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Osteoporosis; Education; Shared Decision-Making; Fragility Fracture
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: PROTECT-2 Pilot

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No