NCT06975254

Brief Summary

Fragility fractures, also known as osteoporotic fractures, are fractures that occur as a result of low-energy trauma or minor impact. They are the most serious complication of osteoporosis and are common bone diseases in the elderly. With our country gradually entering the aging society, the incidence of brittle fracture is increasing year by year, most often in the hip. Hip fracture refers to femoral neck, intertrochanteric and subtrochanteric fractures. Due to a series of complications caused by old age, weak body, many underlying diseases, significant decline in self-care ability and other reasons, it is also known as the last fracture in life. According to reports, within 1 year after hip fracture, only 30% of patients can recover to the functional state before fracture, 20% of patients will fracture again, and even cause lifelong disability, seriously affecting the long-term quality of life of patients, the reason may be related to the long course of disease, slow recovery, postoperative nutrition, rehabilitation exercise compliance, self-care ability decline and many other aspects. The fracture liaison service (FLS) is a nurse-centric, multidisciplinary approach to managing osteoporotic fractures that consists of three key elements: The core of identifying patients with fracture risk, assessing fall risk and initiating treatment to prevent refracture is to hire specialized coordinators to link emergency, orthopedics, rehabilitation, nutrition and other departments with community and family services to provide standardized management services for patients, reduce the incidence of refracture and promote the recovery of joint function of patients. Therefore, this study integrates FLS with "Internet + nursing service" and utilizes the advantages of "Internet + nursing service" in informatization to emphasize the risk assessment of re-fracture of patients at home after discharge, home health guidance (such as fall prevention, rehabilitation training and other related knowledge), online consultation of multidisciplinary teams, offline on-site service, etc., so that patients can be discharged from hospital. Access to ongoing medical care reduces the incidence of complications and promotes rapid recovery.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for not_applicable

Timeline
20mo left

Started Apr 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress40%
Apr 2025Dec 2027

Study Start

First participant enrolled

April 1, 2025

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 2, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 16, 2025

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

May 16, 2025

Status Verified

May 1, 2025

Enrollment Period

1.8 years

First QC Date

April 2, 2025

Last Update Submit

May 8, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Daily Living Ability Rating Scale (ADL)

    Activities of Daily Living (Barthel Index): Used to assess patients' ability to perform daily living activities. The assessment includes: eating, bathing, grooming, dressing, toileting, mobility, bed-chair transfer, stair climbing, and bowel/bladder control. A total score of 100 indicates complete independence without reliance on others; 61-99 points indicate basic independence in daily life; 41-60 points indicate moderate dependence requiring assistance; 21-40 points indicate significant dependence on others for daily activities; and ≤20 points indicate complete dependence on others.

    2 weeks, 1 month, 3 months after discharge

  • Harris Hip Joint Function Scale

    Harris Hip Rating Scale: This study uses the Harris Hip Rating Scale, the most widely applied hip assessment tool in North American hip scoring criteria. Developed by Harris in the United States in 1969, the scale consists of 10 items with respective maximum scores as follows: Pain (44 points), Stair climbing (4 points), Putting on and removing shoes and socks (4 points), Sitting in a chair (5 points), Car travel (1 point), Gait (11 points), Walking aid use (11 points), Walking distance (11 points), Deformity (4 points), and Range of motion (5 points). The total score is 100 points, categorized into four grades: excellent (90-100 points), good (80-90 points), fair (70-80 points), and poor (below 70 points).

    2 weeks, 1 month, 3 months after discharge

  • Complications

    Complications (incidence of recurrent fractures, infection, pressure ulcers, dislocation, etc.).

    2 weeks, 1 month, 3 months after discharge

Study Arms (2)

Will accept the implementation of the "Internet plus care program" based on the FLS model in additio

EXPERIMENTAL

Informed by previous questionnaire survey results on orthopedic home nursing services-including "Analysis of Current Needs and Influencing Factors for Orthopedic Home Nursing Services" (319 orthopedic patients) and "Survey on Nurses' Willingness and Influencing Factors for 'Internet+ Nursing Services' in Orthopedics" (321 orthopedic nurses)-and through literature review on fracture liaison service (FLS) models, this study employs the Delphi method to develop an FLS-based "Internet+ Nursing" protocol. The protocol focuses on: 1) identifying and intervening in risk factors for recurrent fractures; 2) health education on fall prevention, functional exercise, and osteoporosis management; and 3) delivering continuous post-discharge "Internet+ Nursing" services through multidisciplinary collaboration, including online consultations with orthopedic, rehabilitation, nutrition specialists, and specialized nurses, as well as offline home visits.

Other: On the basis of routine nursing, the "Internet + nursing program" based on the FLS model is implemented

Will receive routine perioperative care

NO INTERVENTION

You will receive routine perioperative care, such as orthopedic doctors and nurses will explain the method, function and significance of early functional exercise by your bed before surgery, and assist in routine functional exercise. After the operation, you will receive routine care, the responsible nurse will evaluate and hand over your situation each shift, and explain the postoperative precautions and rehabilitation exercise methods to you and your family members in the form of IPAD education videos and publicity brochures, and receive a 3-month follow-up

Interventions

1\) During hospitalization: After the patient is admitted to hospital, the coordinator will establish wechat contact with the patient face to face and establish a good trust relationship with the patient; The coordinator and the doctor will collect the patients' cases together, and then according to the patients' conditions and wishes, the diagnosis and treatment plan will be formulated jointly by multiple disciplines, including medicine, rehabilitation and nutrition management. 2) Before discharge: the coordinator helps the patient to make an appointment for return visit; Issue business cards of the team's online and offline services to patients and guide them to use wechat and online service application procedures (such as Zheli Care and Dr. Nari); 3) After discharge: patients keep in touch with the liaison staff at any time, and any abnormal situation will be contacted by the liaison staff; Team members supervised the patient's medication situation by punching in the mini program

Will accept the implementation of the "Internet plus care program" based on the FLS model in additio

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Voluntarily signed informed consent
  • Diagnosis of hip fragility fracture (closed type)
  • Scheduled for surgical intervention
  • Adequate communication and comprehension abilities
  • Ability of patient or caregiver to operate smart electronic devices

You may not qualify if:

  • Polytrauma (multiple fractures or major concomitant injuries)
  • Metastatic cancer, metabolic bone disease, or terminal illness
  • Insulin-dependent diabetes mellitus
  • Thyroid disease
  • Inability to participate due to other medical or social factors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Yiwu, Zhejiang, 322000, China

RECRUITING

Study Officials

  • Cheng li Yan, Bachelor

    The Fourth Affiliated Hospital of Zhejiang UniversitySchool of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cheng li Yan, Bachelor

CONTACT

Yu yu Chen, Master

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2025

First Posted

May 16, 2025

Study Start

April 1, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Last Updated

May 16, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations