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

July 27, 2015 updated by: Kwok-Sui Leung, Chinese University of Hong Kong

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

160

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Hong Kong, China
        • Department of Orthopaedics and Traumatology, The Chinese University of Hong Kong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 90 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Conventional care program
Experimental: Multi-disciplinary management program
Other: Multi-disciplinary management program
conventional healthcare program for fragility fracture patients plus vibration treatment, exercise class and educational talk

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cost effectiveness of the multi-disciplinary management program and conventional care program
Time Frame: 1 year
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mobility
Time Frame: 1 year
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Collaborators

Queen Elizabeth Hospital, Hong Kong

Investigators

  • Principal Investigator: Kwok-Sui Leung, MD, Department of Orthopaedics and Traumatology, The Chinese University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

June 23, 2011

First Submitted That Met QC Criteria

June 24, 2011

First Posted (Estimate)

June 27, 2011

Study Record Updates

Last Update Posted (Estimate)

July 29, 2015

Last Update Submitted That Met QC Criteria

July 27, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4013-PPR-09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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