Multifactorial, Evidence-based Program of Screening, Risk Modification and Physical Therapy to Prevent Falls Among Vulnerable Elderly Recently Discharged From Hospital to the Community.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 354
- Locations
- 2
- Primary Endpoint
- The number of fallers who have fallen at least once during the 9-month study period
Study Overview
Brief Summary
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.
Detailed Description
Objective:
To develop and demonstrate the feasibility and effectiveness of a multifactorial, community-based falls prevention program of screening, risk modification, and progressive physical therapy that targets vulnerable elderly Singaporeans at high-risk of falls.
Methodology:
This two-year, multi-center, two-arm, parallel group, randomized controlled trial will be divided into three phases: (1) pre-study, (2) intervention, and (3) analysis.
During the pre-study phase, overseas experts will train local physiotherapists and community health workers on how to administer and deliver the falls prevention program. Engaging hospital-based physiotherapists to deliver the home-based assessments and exercise programs will maximize the likelihood of long-term sustainability of the intervention program. In addition, manuals will be developed for physiotherapists to guide the evaluation risk factor assessments, home environment assessments, appropriate referrals to different health care providers, and selection of exercise programs that will be progressive, challenging and of optimal intensity and durations. Manuals for risk factor assessments will be shared with the blinded assessors.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Intervention Group
The intervention consists of a tailored physical therapy focused on progressive strength, balance and gait training for a period of 3 months.
Intervention: physical therapy (Other)
Control Group
Usual care by physician.
Outcomes
Primary Outcomes
The number of fallers who have fallen at least once during the 9-month study period
Time Frame: 9 months
Secondary Outcomes
- The number of injurious falls and healthcare utilization(9 months)
Investigators
Dr. David Matchar
Professor and Director, Program in Health Services & Systems Research, Duke-NUS
National University of Singapore