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

This study is currently recruiting participants.
Verified April 2012 by Chinese University of Hong Kong
Sponsor:
Collaborator:
Queen Elizabeth Hospital, Hong Kong
Information provided by (Responsible Party):
Kwok-Sui Leung, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01382875
First received: June 23, 2011
Last updated: April 23, 2012
Last verified: April 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Hip Fracture
 Other: Multi-disciplinary management program
 Phase 3

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • Cost effectiveness of the multi-disciplinary management program and conventional care program [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Mobility [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 160
Study Start Date: September 2009
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   65 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01382875

Contacts
Contact: Kwok-Sui Leung, MD (852)26322724 ksleung@cuhk.edu.hk
Contact: Wing Hoi Cheung, PhD (852)26321559 louis@ort.cuhk.edu.hk

Locations
China
Department of Orthopaedics and Traumatology, The Chinese University of Hong Kong Recruiting
Hong Kong, China
Contact: Kwok-Sui Leung, MD     (852)26322724     ksleung@cuhk.edu.hk    
Contact: Wing-Hoi Cheung, PhD     (852)26321559     louis@ort.cuhk.edu.hk    
Principal Investigator: Kwok-Sui Leung, MD            
Sub-Investigator: Wing-Hoi Cheung, PhD            
Sponsors and Collaborators
Chinese University of Hong Kong
Queen Elizabeth Hospital, Hong Kong
Investigators
Principal Investigator: Kwok-Sui Leung, MD Department of Orthopaedics and Traumatology, The Chinese University of Hong Kong
  More Information

No publications provided

Responsible Party: Kwok-Sui Leung, Chair Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT01382875     History of Changes
Other Study ID Numbers: 4013-PPR-09
Study First Received: June 23, 2011
Last Updated: April 23, 2012
Health Authority: Hong Kong: Department of Health
Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

Keywords provided by Chinese University of Hong Kong:
Multi-disciplinary management program
Conventional care program
Balance Ability
Quality of Life

Additional relevant MeSH terms:
Fractures, Bone
Hip Fractures
Wounds and Injuries
 Femoral Fractures
Hip Injuries
Leg Injuries

ClinicalTrials.gov processed this record on May 19, 2013