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

NCT06102954 | Recruiting

• 1 other identifier: NUS-IRB-2023-496
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Fall; Injurious fall; Falls Prevention Intervention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Number of Injurious Fallers

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

• Physical Function

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

• Fear of Falling

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

• Practice of Falls Prevention Behaviours

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

Study Arms (2)

Intervention group

EXPERIMENTAL

12-weeks active intervention session includes exercise and educational components. 9 months maintenance phase

Other: Falls prevention intervention including exercise and educational components

Control group

NO INTERVENTION

No intervention for 12 months during intervention period.

Interventions

Falls prevention intervention including exercise and educational components OTHER

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).

Intervention group

Eligibility Criteria

• Age: 60 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Duke-NUS Graduate Medical School: lead

Study Sites (1)

Centre for Ageing Research & Education

Singapore, 169857, Singapore

RECRUITING

Related Publications (3)

• 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.

  PMID: 30165053 BACKGROUND

• 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.

  PMID: 28202383 BACKGROUND

• Lai WX, Koh V, Goh JW, Tan KY, Tan KZ, Pai SGS, Taylor WR, Visaria A, Singh NB, Chan AWM, Matchar DB. Steps to Avoid Falls in the Elderly - a TECHnology Enhanced Intervention (SAFE-TECH) study: randomized controlled trial protocol for a community-based, multi-component fall prevention program. BMC Public Health. 2024 Dec 18;24(1):3464. doi: 10.1186/s12889-024-20947-2.

  PMID: 39695436 DERIVED

Study Officials

• Matchar David Bruce

  Duke-NUS Graduate Medical School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jing Wen Goh

CONTACT

+65 6601 3889; jingwen_goh@duke-nus.edu.sg

Kok Yang Tan

CONTACT

kokyang.tan@duke-nus.edu.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 15, 2023
• First Posted: October 26, 2023
• Study Start: March 1, 2024
• Primary Completion: February 28, 2026
• Study Completion: February 28, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)