A Multi-domain and Multi-component Falls Intervention Program for Community- Dwelling Older Adults: SAFE-TECH

Recruiting now · Not applicable

Conditions studied: Fall Prevention, Fall Injury

In brief

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.

Key facts

Study ID

NCT06102954

Run by

Duke-NUS Graduate Medical School

People needed

400

Starts

2024-03-01

Expected to finish

2026-02-28

Last updated by the study team

2024-09-19

Who can join

Age: 60 and older, up to 95. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Aged 60 to 95 years
• Ambulatory with or without walking aid
• Does not possess cognitive impairment with an Abbreviated Mental Score-Singapore \>=6

You may not qualify if…

• Had any significant morbidity:
• Congestive Heart Failure in the past 6 months
• Myocardial Infarction in the past 6 months
• Stroke (Intra-Cranial Haemorrhage) in the past 6 months
• Concussion or Head Injury in the past 6 months
• End Stage Renal Failure requiring dialysis
• Severe Asthma or Chronic Obstructive Pulmonary Disease (COPD) (e.g. Chronic Lung Disease or Chronic Bronchitis or Emphysema), experiencing symptoms at rest or with mild activity
• Lower Limb Fractures in the past 6 months
• Blindness, with or without the use of any visual aids
• Deafness, with or without the use of any hearing aids
• Currently experiencing one of the following:
• Chest discomfort, or
• Breathlessness, or
• Dizziness, or
• Profuse sweating
• Had an amputation of any part of the lower limbs except toes, or had an amputation of any toes in the last 30 days
• Currently in a long-term institution
• Currently participating in any randomized clinical or controlled trial that involves physical exercise
• Unwilling to complete the baseline gait assessment, or complete less than 3 minutes of the 5-minute baseline gait assessment

Where it is running

• Centre for Ageing Research & Education — Singapore, Singapore (enrolling)

Full record on ClinicalTrials.gov

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