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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Fall Injury; Fall Prevention
• Intervention / Treatment: Other: Falls prevention intervention including exercise and educational components

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jing Wen Goh; Phone Number: +65 6601 3889; Email: jingwen_goh@duke-nus.edu.sg
• Study Contact Backup: Name: Kok Yang Tan; Email: kokyang.tan@duke-nus.edu.sg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; No intervention for 12 months during intervention period.
Experimental: Intervention group; 12-weeks active intervention session includes exercise and educational components. 9 months maintenance phase	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).

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Duke-NUS Graduate Medical School
• Investigators: Principal Investigator: Matchar David Bruce, Duke-NUS Graduate Medical School

Publications and helpful links

General Publications

• Matchar DB, Duncan PW, Lien CT, Ong MEH, Lee M, Gao F, Sim R, Eom K. Randomized Controlled Trial of Screening, Risk Modification, and Physical Therapy to Prevent Falls Among the Elderly Recently Discharged From the Emergency Department to the Community: The Steps to Avoid Falls in the Elderly Study. Arch Phys Med Rehabil. 2017 Jun;98(6):1086-1096. doi: 10.1016/j.apmr.2017.01.014. Epub 2017 Feb 12.
• Matchar DB, Eom K, Duncan PW, Lee M, Sim R, Sivapragasam NR, Lien CT, Ong MEH. A Cost-Effectiveness Analysis of a Randomized Control Trial of a Tailored, Multifactorial Program to Prevent Falls Among the Community-Dwelling Elderly. Arch Phys Med Rehabil. 2019 Jan;100(1):1-8. doi: 10.1016/j.apmr.2018.07.434. Epub 2018 Aug 27.

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): February 28, 2026
• Study Completion (Estimated): February 28, 2026

Study Registration Dates

• First Submitted: October 15, 2023
• First Submitted That Met QC Criteria: October 22, 2023
• First Posted (Actual): October 26, 2023

Study Record Updates

• Last Update Posted (Actual): October 26, 2023
• Last Update Submitted That Met QC Criteria: October 22, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Fall; Injurious fall; Falls Prevention Intervention
• Other Study ID Numbers: IRB (Other Identifier: University of Rhode Island)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No