A Multi-domain and Multi-component Falls Intervention Program for Community- Dwelling Older Adults: SAFE-TECH
NCT06102954 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400
Last updated 2024-09-19
Summary
Background: Falls and fall-related injuries among older adults are a significant health problem that results in injuries, prolonged hospitalisation, reduced mobility, and poorer quality of life. Previous falls prevention programs have demonstrated the effectiveness of multi-component falls prevention interventions in improving functional outcomes and reducing falls compared to usual care. A previous trial of a tailored multi-component falls intervention program for older adults recruited from the emergency department (SAFE) found that there is significant heterogeneity in terms of falls risk factors in high falls risk older adults. Thus, the effectiveness of SAFE in participants with poorer cognitive function or had more comorbidities were less effective and less cost-effective. Therefore, the aim of this trial is to demonstrate the effectiveness of a technology-enhanced, multi-domain and multi-component falls prevention intervention in reducing number of fallers and injurious fallers among older adults with elevated fall risk.
Hypothesis: Using novel wearable technologies to a) identify older adults who are at high risk of falls and more likely to benefit from a multi-component intervention and b) tailor the exercise and educational components by giving individualized biofeedback will improve the effectiveness of an enhanced multi-domain, multi-component falls intervention program for community dwelling older adults.
Methodology: This study is a randomized controlled trial aimed at demonstrating the effectiveness of a technology-enhanced, multi-domain and multi-component falls prevention intervention (SAFE-TECH) in community- dwelling older adults with elevated fall risk compared with usual care. Participants in both arms are selected based on questionnaire based and wearable sensor based predictions of their falls risk. Participants in the intervention arm will receive a 12-week active falls intervention program consisting of exercise and educational components, with detailed biofeedback of their functional status.
Conditions
- Fall Prevention
- Fall Injury
Interventions
- OTHER
-
Falls prevention intervention including exercise and educational components
This includes five domains of exercise (strength, balance, flexibility, coordination, and endurance) and educational components to manage other falls risk factors (polypharmacy, nutrition, pain, orthostatic hypotension, poor vision and environmental hazard evaluations).
Sponsors & Collaborators
-
Duke-NUS Graduate Medical School
lead OTHER
Principal Investigators
-
Matchar David Bruce · Duke-NUS Graduate Medical School
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 60 Years
- Max Age
- 95 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-03-01
- Primary Completion
- 2026-02-28
- Completion
- 2026-02-28
Countries
- Singapore
Study Locations
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