search
Back to results

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

Primary Purpose

Hip Fracture

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Multi-disciplinary management program
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Hip Fracture focused on measuring Multi-disciplinary management program, Conventional care program, Balance Ability, Quality of Life

Eligibility Criteria

65 Years - 90 Years (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Conventional care program

Multi-disciplinary management program

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
June 23, 2011
Last Updated
July 27, 2015
Sponsor
Chinese University of Hong Kong
Collaborators
Queen Elizabeth Hospital, Hong Kong
search

1. Study Identification

Unique Protocol Identification Number
NCT01382875
Brief Title
The Comparison of Comprehensive Multi-disciplinary Program and Conventional Care Program on Fragility Fracture Elderly
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 Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
Collaborators
Queen Elizabeth Hospital, Hong Kong

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fracture
Keywords
Multi-disciplinary management program, Conventional care program, Balance Ability, Quality of Life

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional care program
Arm Type
No Intervention
Arm Title
Multi-disciplinary management program
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Multi-disciplinary management program
Intervention Description
conventional healthcare program for fragility fracture patients plus vibration treatment, exercise class and educational talk
Primary Outcome Measure Information:
Title
Cost effectiveness of the multi-disciplinary management program and conventional care program
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Mobility
Description
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.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kwok-Sui Leung, MD
Organizational Affiliation
Department of Orthopaedics and Traumatology, The Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Orthopaedics and Traumatology, The Chinese University of Hong Kong
City
Hong Kong
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs