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

Study Overview
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Brief Summary
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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.

Detailed Description
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Objective: To demonstrate the feasibility and effectiveness of a technology-enhanced multi-domain, multi-component falls intervention program consisting of screening, assessments, progressive physical therapy and education to reduce falls and injurious falls in community-dwelling older adults in Singapore. Methodology: This study is a multi-center, two-arm, parallel group, randomized controlled trial with 400 participants allocated to the intervention and control arm in a 1:1 ratio. In the intervention arm, participants will be enrolled in a multi-domain, multi-component falls intervention program that consists of exercise and educational components for 12 weeks. The exercise components are progressive and tailored to individual falls risk factors. Exercises aim to improve 5 domains of physical function: strength, balance, flexibility, coordination, and aerobic endurance. The educational components focus on the management of fall risk factors such as polypharmacy, nutrition, pain, orthostatic hypotension, poor vision, and environmental hazards. The education sessions also provide feedback based on individualized falls risk assessments. After the 12-week active intervention phase, the participants in the intervention arm will enter a 9-month maintenance phase where they will be encouraged to maintain their physical activity, and continue practicing falls prevention behavior. The study will collect information from both intervention and control arm on their living situation, cognitive function, quality of life, general health, falls history, behavioral and psychosocial characteristics, handgrip strength, orthostatic hypotension, ankle mobility, physical function (Short Performance Physical Battery) and gait assessment (ZurichMOVE system of wearable gait sensors) at baseline, 3rd-months and 12th-months into the study. Monthly follow-up calls will be done to collect participants' fall status, healthcare utilisation, physical activity, and exercise self- efficacy over the 12-month period.

Official Title
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Steps to Avoid Falls in the Elderly- A TECHnology Enhanced Intervention

Conditions
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Fall Prevention, Fall Injury

Intervention / Treatment
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* Other: Falls prevention intervention including exercise and educational components


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 60 years or above Ambulatory with or without walking aid Able to see with or without glasses Able to hear with or without hearing aids Does not have significant cognitive impairment: Abbreviated Mental Score- Singapore >=6 Exclusion Criteria: Had any of the following: 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 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 the toes, and if the amputation surgery was done in the last 30 days) Currently in a long-term institution A current participant in any randomized clinical/ controlled trial with exercise Unable/ unwilling to complete gait assessment

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 105 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>12-weeks active intervention session includes exercise and educational components. 9 months maintenance phase | Other: Falls prevention intervention including exercise and educational components<br>* 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).<br>|
| No Intervention: Control group<br>No intervention for 12 months during intervention period. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Fallers | Evaluation of number of falls in 12 months | Baseline, Monthly phone call follow-up for 1 year, 12th-month after first intervention session | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Injurious Fallers | Evaluation of number of injurious falls in 12 months | Baseline, Monthly phone call follow-up for 1 year, 12th-month after first intervention session | 
| 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. | Baseline, 3rd-month and 12th-month after first intervention session | 
| 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. | Baseline, 3rd-month and 12th-month after first intervention session | 
| 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. | Baseline, 3rd-month and 12th-month after first intervention session | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fall, Injurious fall, Falls Prevention Intervention