Establishment of an Integrated Model for Prevention of Elderly Falls

This study has been completed.
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00804492
First received: December 4, 2008
Last updated: June 28, 2010
Last verified: June 2010
  Purpose

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

  1. To organize a multidisciplinary team for integrated falls prevention.
  2. To draft a guideline for falls prevention in the elderly.
  3. To set up a multidisciplinary fall clinic.
  4. To set up a falls prevention classroom.
  5. To enhance cooperate between hospitals and primary care units to fulfill the guideline for falls prevention in the elderly.

Condition Intervention
Falls
Behavioral: Multifaceted intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Bureau of Health Promotion,Department of Health, R.O.C. (Taiwan)

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • The number and severity of fall [ Time Frame: once per month for 6 monthes ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 900
Study Start Date: June 2008
Study Completion Date: December 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
To establish an integrated intervention model for prevention of elderly fall
Behavioral: Multifaceted intervention
consulted, educated, referred or receive an exercise training for their fitness, strength and balance
Experimental: 2
To perform a RCT to investigate the effectiveness of the multicenter, multifaceted intervention program
Behavioral: Multifaceted intervention
consulted, educated, referred or receive an exercise training for their fitness, strength and balance

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00804492

Locations
Taiwan
Jau-Yih Tsauo
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Jau-Yih Tsauo National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: Jau-Yih Tsauo, National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00804492     History of Changes
Other Study ID Numbers: 200710010R
Study First Received: December 4, 2008
Last Updated: June 28, 2010
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
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 for falls prevention

ClinicalTrials.gov processed this record on July 31, 2014