Establishment of an Integrated Model for Prevention of Elderly Falls

Falls Clinical Trial

Official title:

Bureau of Health Promotion,Department of Health, R.O.C. (Taiwan)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00804492
• Other study ID #: 200710010R
• Status: Completed
• Phase: N/A
• First received: December 4, 2008
• Last updated: June 28, 2010
• Start date: June 2008
• Est. completion date: December 2009

Study information

• Verified date: June 2010
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 900
• Est. completion date: December 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Falls

Intervention

Behavioral:
• Multifaceted intervention
consulted, educated, referred or receive an exercise training for their fitness, strength and balance

Locations

Country	Name	City	State
Taiwan	Jau-Yih Tsauo	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number and severity of fall		once per month for 6 monthes	Yes