NCT00804492

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
900

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 4, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 8, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

June 29, 2010

Status Verified

June 1, 2010

Enrollment Period

1.3 years

First QC Date

December 4, 2008

Last Update Submit

June 28, 2010

Conditions

Keywords

To organize a multidisciplinary team for integrated falls preventionTo draft a guideline for falls prevention in the elderlyTo set up a multidisciplinary fall clinicTo set up a falls prevention classroomTo enhance cooperate between hospitals and primary care units for falls prevention

Outcome Measures

Primary Outcomes (1)

  • The number and severity of fall

    once per month for 6 monthes

Study Arms (2)

1

EXPERIMENTAL

To establish an integrated intervention model for prevention of elderly fall

Behavioral: Multifaceted intervention

2

EXPERIMENTAL

To perform a RCT to investigate the effectiveness of the multicenter, multifaceted intervention program

Behavioral: Multifaceted intervention

Interventions

consulted, educated, referred or receive an exercise training for their fitness, strength and balance

12

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jau-Yih Tsauo

Taipei, Taiwan, 100, Taiwan

Location

Study Officials

  • Jau-Yih Tsauo

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 4, 2008

First Posted

December 8, 2008

Study Start

June 1, 2008

Primary Completion

October 1, 2009

Study Completion

December 1, 2009

Last Updated

June 29, 2010

Record last verified: 2010-06

Locations