Community-based Falls Prevention Program for the Elderly

This study has been completed.
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
Jurong Health Services
Information provided by (Responsible Party):
Dr. David Matchar, National University, Singapore
ClinicalTrials.gov Identifier:
NCT01713543
First received: October 22, 2012
Last updated: September 4, 2015
Last verified: September 2015
  Purpose

Background: Falls are the leading cause of injury among older adults in Singapore, but falls among the elderly can be preventable and the risks are predictable. Translating this understanding of falls etiology into an integrated clinical and public health program that is accessible to the elderly 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 recurrent falls incidence among a high-risk group of elderly recently discharged to the community.

Methodology: This randomized controlled trial targets patients seen at Emergency Department (ED) for a fall or fall-related injuries who are at least 65 years old and will be discharged to home. Upon signing the informed consent form, the participants will be followed up for nine months from the baseline assessment during which the participants are randomized into either a control or the intervention group. The participants in the intervention group will be provided with a multifactorial program of screening, risk modification and physical therapy focused on progressive strength, balance, and gait training either as an individualized program or a group setting in the community for the first three months from the date of randomization. The number of recurrent falls will be monitored via a falls prevention diary maintained by (or for) each participant.


Condition Intervention
Accidental Falls
Other: physical therapy

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:


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 study period [ 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 ]
    Injurious falls are the falls that resulted in participants' seeking medical attention or restricting their daily activities for at least 48 hours.


Enrollment: 354
Study Start Date: December 2012
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention Group
The intervention consists of a tailored physical therapy focused on progressive strength, balance and gait training for a period of 3 months.
Other: physical therapy
Tailored physical therapy sessions to modify impairments in balance and/or gait and to transition high-risk participants to an evidence-based group exercise program.
Other Name: Falls Prevention
No Intervention: Control Group
Usual care by physician.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   65 Years and older   (Adult, Senior)
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 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
  • Patients seen at ED due to road traffic accidents
  • Unable to walk even with assistance
  • Not community dwelling prior to ED visit
  • Total blindness
  • Needs emergency inpatient surgery and, 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
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: NCT01713543

Locations
Singapore
Singapore General Hospital
Singapore, Singapore, 169608
Changi General Hospital
Singapore, Singapore, 529889
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
Jurong Health Services
Investigators
Principal Investigator: David B Matchar, MD Duke-NUS Graduate Medical School
  More Information

Publications:
Responsible Party: Dr. David Matchar, Professor and Director, Program in Health Services & Systems Research, Duke-NUS, National University, Singapore
ClinicalTrials.gov Identifier: NCT01713543     History of Changes
Other Study ID Numbers: HSRG10MAY002 
Study First Received: October 22, 2012
Last Updated: September 4, 2015
Health Authority: Singapore: Domain Specific Review Boards

Keywords provided by National University, Singapore:
falls

ClinicalTrials.gov processed this record on July 24, 2016