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

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ClinicalTrials.gov Identifier: NCT01382875
Recruitment Status : Completed
First Posted : June 27, 2011
Last Update Posted : July 29, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief 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.


Condition or disease Intervention/treatment Phase
Hip Fracture Other: Multi-disciplinary management program Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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
Study Start Date : September 2009
Primary Completion Date : December 2012
Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria

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Ages Eligible for Study:   65 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01382875


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

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
First Posted: June 27, 2011    Key Record Dates
Last Update Posted: July 29, 2015
Last Verified: July 2015

Keywords provided by Kwok-Sui Leung, 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