The Comparison of Comprehensive Multi-disciplinary Program and Conventional Care Program on Fragility Fracture Elderly

Hip Fracture Clinical Trial

Official title:

Medico-social Impact of a Comprehensive Multi-disciplinary Program for the Care of Fragility Fracture of the Elderly -Implications for Healthcare Policy in Hong Kong

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01382875
• Other study ID #: 4013-PPR-09
• Status: Completed
• Phase: Phase 3
• First received: June 23, 2011
• Last updated: July 27, 2015
• Start date: September 2009
• Est. completion date: December 2012

Study information

• Verified date: July 2015
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Department of HealthHong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Fragility fractures are one of the commonest injuries among elderly people in Hong Kong and account for 12% of the disease burden in elderly aged 65 or above.

A good management healthcare program and training helps elderly to restore full functional level and prevent re-fracture in the following 2 years after primary fracture, but Hong Kong lacks of such program. Some reports from other countries pointed out a well-organized multi-disciplinary management programs are cost-effective to identify and treat osteoporosis, reduce the fracture rate, improve quality of life and raise awareness of fragility fracture.

This study aims to compare the cost-effectiveness of multi-disciplinary management program with conventional care controls. The clinical effectiveness outcomes (re-fracture rate, fall rate, mortality, mobility, quality of life and specialist follow-up time) of the fragility hip fracture patients in New Territories East receiving the proposed management program will be compared with those from Kowloon Central with usual care as controls. The findings will provide useful data for the policy maker to evaluate the current clinical service for fragility fracture patients and consider the implementation of new multi-disciplinary management program into our healthcare system.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years to 90 Years

Eligibility

Inclusion Criteria:

• Fragility hip fracture patients within age 65-90

Exclusion Criteria:

• Taking medication affecting bone metabolism or intensive exercise training;

• Those living in old age homes or anyone who is not able to comply with our program

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fracture
• Hip Fractures

Intervention

Other:
• Multi-disciplinary management program
conventional healthcare program for fragility fracture patients plus vibration treatment, exercise class and educational talk

Locations

Country	Name	City	State
China	Department of Orthopaedics and Traumatology, The Chinese University of Hong Kong	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
Chinese University of Hong Kong	Queen Elizabeth Hospital, Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cost effectiveness of the multi-disciplinary management program and conventional care program	The expected costs of fragility fracture treatment and re-fracture at the hip are calculated from the prospective of hospital and community center cost, with a time frame of one year.	1 year	No
Secondary	Mobility	The patients will be asked to perform mobility assessments according to our established protocol, including timed-up-to-go, mobility score, Berg balance scale and fall risk screening. The result of the above assessments will be reported as a scoring to show the level of fall risk of the patient.	1 year	No