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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-95
SponsorDuke-NUS Graduate Medical School

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 60 to 95 years

Ambulatory with or without walking aid

Does not possess cognitive impairment with an Abbreviated Mental Score-Singapore >=6

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Falls prevention intervention including exercise and educational components

    Other intervention

    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).

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: Intervention groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Number of Fallers

Evaluation of number of falls in 12 months

Time frame
Baseline, Monthly phone call follow-up for 1 year, 12th-month after first intervention session

Secondary outcomes

1

Number of Injurious Fallers

Evaluation of number of injurious falls in 12 months

Time frame
Baseline, Monthly phone call follow-up for 1 year, 12th-month after first intervention session
2

Physical Function

Evaluation of change in physical function using Short Physical Performance Battery test (SPPB) \[range from 0 to 12 score\].A higher score represents a higher physical function level.

Time frame
Baseline, 3rd-month and 12th-month after first intervention session
3

Fear of Falling

Evaluation of change in falls efficacy using Iconographical Falls Efficacy Scale (Icon-FES). A higher value represents a high concern for falling.

Time frame
Baseline, 3rd-month and 12th-month after first intervention session
4

Practice of Falls Prevention Behaviours

Evaluation of change in practice of falls prevention behaviours by using Falls Behavioral Scale (FaB). A higher value represents a better practice of falls prevention behaviours.

Time frame
Baseline, 3rd-month and 12th-month after first intervention session

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.