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Community-based Falls Prevention Program for the Elderly

This study is currently recruiting participants.
Verified January 2012 by National University, Singapore
Sponsor:
Collaborators:
Ministry of Health, Singapore
Duke-NUS Graduate Medical School
Singapore General Hospital
Changi General Hospital
Health Promotion Board, Singapore
Agency for Integrated Care, Singapore
Information provided by (Responsible Party):
Dr. David Matchar, National University, Singapore
ClinicalTrials.gov Identifier:
NCT01713543
First received: October 22, 2012
Last updated: December 17, 2012
Last verified: January 2012
History of Changes
  Purpose

Background: Falls are the leading cause of injury among older adults in Singapore. However, far from being inevitable, falls among elderly are preventable and risk is predictable. Translating this understanding of falls etiology into an integrated clinical and public health program that is accessible to all elderly persons is a critical health services delivery challenge.

Hypothesis: An evidence-based program of screening, risk modification and physical therapy delivered in a community setting will reduce falls incidence among a high-risk group of elderly who have been recently transitioned from the hospital to the community.

Methodology: Randomized controlled trial. Patients transitioning from the hospital to the community will be identified at the Emergency Department. Eligible patients are those who are: 1) more than 65 years old, 2) discharged from the Emergency Department or hospital for a fall or injury related to a fall. The intervention is a multifactorial program of screening, risk modification and physical therapy focused on progressive strength, balance and gait training. It is provided as an individualized program or in a group setting in the community. The primary outcome measure is number of fallers assessed from a falls prevention diary maintained by (or for) each participant.


Condition Intervention
Falls Prevention
 Other: active exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Multifactorial, Evidence-based Program of Screening, Risk Modification and Physical Therapy to Prevent Falls Among Vulnerable Elderly Recently Discharged From Hospital to the Community.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National University, Singapore:

Primary Outcome Measures:
  • The number of fallers who have fallen at least once during the 9-month intervention phase [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The number of injurious falls and healthcare utilization [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 350
Study Start Date: December 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention Group Other: active exercise
Tailored physical therapy sessions to modify impairments and transition participants to an evidence-based group exercise program.
Other Name: Falls Prevention
No Intervention: Control Group

  Show Detailed Description

  Eligibility

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

Inclusion Criteria:

  • Age ≥ 65 years
  • Seen in the Emergency Department for a fall or injury related to a fall
  • Able to follow 3 step commands
  • Singapore citizen or Permanent Resident
  • Living at home upon discharge
  • Provision of informed consent
  • If admitted to the hospital, the illness or disability is one from which they are expected to recover basic ADLs or weight bearing of the lower extremity within the next one month

Exclusion Criteria:

  • Those patients with severe physical and/or mental impairments which preclude participation in a program of physical therapy (as determined by a primary physician) will NOT be eligible for participation.
  • Unable to participate in the exercise program due to conflicting schedules (e.g. full-time employment, on dialysis)
  • Serious life limiting illness
  • Road traffic accident
  • Unable to walk even with assistance
  • Not community dwelling prior to ED visit
  • Total blindness
  • Needs emergency inpatient surgery and (8) if admitted to the hospital, the illness or disability is one from which they are not expected to recover basic ADLs or weight bearing in the lower extremity within the next one month.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01713543

Contacts
Contact: Rita Sim (65) 6601 2453 rita.sim@duke-nus.com.sg

Locations
Singapore
Singapore General Hospital Recruiting
Singapore, Singapore, 169608
Contact: Marcus Ong, MD     (65) 6321 4873     marcus.ong.e.h@sgh.com.sg    
Principal Investigator: Marcus Ong, MD            
Changi General Hospital Recruiting
Singapore, Singapore, 529889
Contact: Christopher Lien, MD     (65) 6850 3604     chris_lien@cgh.com.sg    
Principal Investigator: Christopher Lien, MD            
Sponsors and Collaborators
National University, Singapore
Ministry of Health, Singapore
Duke-NUS Graduate Medical School
Singapore General Hospital
Changi General Hospital
Health Promotion Board, Singapore
Agency for Integrated Care, Singapore
Investigators
Principal Investigator: David B Matchar, MD Duke-NUS Graduate Medical School
  More Information

No publications provided

Responsible Party: Dr. David Matchar, Professor, National University, Singapore
ClinicalTrials.gov Identifier: NCT01713543     History of Changes
Other Study ID Numbers: HSRG10MAY002
Study First Received: October 22, 2012
Last Updated: December 17, 2012
Health Authority: Singapore: Domain Specific Review Boards

Keywords provided by National University, Singapore:
falls

ClinicalTrials.gov processed this record on May 19, 2013