- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00804492
Establishment of an Integrated Model for Prevention of Elderly Falls
Bureau of Health Promotion,Department of Health, R.O.C. (Taiwan)
Falls, with a high prevalence, high risk and consequent medical and social costs, are an important issue for medical care and health promotion in the elderly. The prevalence of falls in the elderly lies in between 10-20%. Falls have become the second leading cause of death from injury for the elderly in Taiwan. A community-based study showed that, among those old adults after a fall, 27.3% were severely injured, 53.9% got a minor injury, and only 18.9% remained intact. Another study revealed that among fall injury events reported, 42% were hospitalized, of whom 2.2% died in hospital, and 37% entered nursing homes after discharge from hospital. In addition to physical discomfort, half of the elderly fallers would become disabled, and bring a heavy burden of social economy and family care. It was estimated that there were 460 thousand of old people who had a fall, and 125 thousand of them were injured in Taiwan, 2007. Research evidence shows that falls prevention is effective and feasible. Although primary falls prevention programs have been conducted at the community level and extended to 25 counties and cities for many years, they were not integrated with secondary and tertiary prevention. The study aims to establish an integrated fall prevention model, combined with primary, secondary and tertiary prevention. The model will be practiced in participating hospitals and communities, with a randomized control trial (RCT) design to examine its feasibility and effectiveness. Our study subjects are persons aged 65 and over who live in communities, go to out-patient departments (OPD) or emergency room (ER) care.
Tasks for implementation
- To organize a multidisciplinary team for integrated falls prevention.
- To draft a guideline for falls prevention in the elderly.
- To set up a multidisciplinary fall clinic.
- To set up a falls prevention classroom.
- To enhance cooperate between hospitals and primary care units to fulfill the guideline for falls prevention in the elderly.
Study Overview
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Taipei, Taiwan, 100
- Jau-Yih Tsauo
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Old people (65 years old or more)
- With at least one fall in the past one year, or with disease related to fall, such as central nerve system disease or lower extrimity fracture
Exclusion Criteria:
- The result of screening test is "no fall risk"
- Cannot be followed for 6 months
- Cannot be evaluated because of the mental status
- Cannot have the exercise intervention
- Falling due to expected reason, such as suffering heart atteck
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
To establish an integrated intervention model for prevention of elderly fall
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consulted, educated, referred or receive an exercise training for their fitness, strength and balance
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Experimental: 2
To perform a RCT to investigate the effectiveness of the multicenter, multifaceted intervention program
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consulted, educated, referred or receive an exercise training for their fitness, strength and balance
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The number and severity of fall
Time Frame: once per month for 6 monthes
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once per month for 6 monthes
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Collaborators and Investigators
Investigators
- Principal Investigator: Jau-Yih Tsauo, National Taiwan University Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 200710010R
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