Fall PreventionSAFE-TECHNCT06102954
A Multi-domain and Multi-component Falls Intervention Program for Community- Dwelling Older Adults: SAFE-TECH
A study testing Falls prevention intervention including exercise and educational components in people with Fall Prevention and Fall Injury, run by Duke-NUS Graduate Medical School at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 95 years
- Conditions the study is for
- Fall Prevention, Fall Injury
- What is being tested?
- Falls prevention intervention including exercise and educational components
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Mar 2024to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 60 to 95 years
- Ambulatory with or without walking aid
- Does not possess cognitive impairment with an Abbreviated Mental Score-Singapore \>=6
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Kok Yang Tan contact
Singapore1 site, 1 recruiting
- Recruiting
Centre for Ageing Research & Education
Singapore, 169857
+65 6516 7666
About this study
Official title: 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.
Read the 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.
- Conditions
- Fall Prevention, Fall Injury
- Being tested
- Falls prevention intervention including exercise and educational components
- Keywords
- Fall, Injurious fall, Falls Prevention Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Falls prevention intervention including exercise and educational componentsOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 12-weeks active intervention session includes exercise and educational components.
9 months maintenance phase Receives: Other: Falls prevention intervention including exercise and educational components |
| Control group | No intervention | No intervention for 12 months during intervention period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Fallers
Evaluation of number of falls in 12 months
Measured: Baseline, Monthly phone call follow-up for 1 year, 12th-month after first intervention session
Secondary outcomes (4)
Number of Injurious Fallers
Evaluation of number of injurious falls in 12 months
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 3rd-month and 12th-month after first intervention session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start1 Mar 2024
- Primary completion28 Feb 2026 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Fall PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke-NUS Graduate Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Bruce Matchar, Duke-NUS Graduate Medical School
- Investigators
- Matchar David Bruce, Principal investigator, Duke-NUS Graduate Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06102954
- Sponsor's protocol ID
- NUS-IRB-2023-496
- Acronym
- SAFE-TECH
- Status last verified
- Sep 2024
- First submitted
- 15 Oct 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30165053Matchar 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.
PubMed 28202383Lai 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.
PubMed 39695436
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Steps to Avoid Falls in the Elderly- A TECHnology Enhanced Intervention
- ClinicalTrials.gov ID
- NCT06102954
- Acronym / sponsor ID
- SAFE-TECH / NUS-IRB-2023-496
- Conditions
- Fall Prevention, Fall Injury
- Keywords
- Fall, Injurious fall, Falls Prevention Intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Duke-NUS Graduate Medical SchoolUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 26 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Falls prevention intervention including exercise and educational components12-weeks active intervention session includes exercise and educational components. 9 months maintenance phase |
| Control group | No intervention | –No intervention for 12 months during intervention period. |
Who may qualify
- Ages
- 60 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 60 to 95 years
- Ambulatory with or without walking aid
- Does not possess cognitive impairment with an Abbreviated Mental Score-Singapore \>=6
Key exclusion criteria (19 listed)
- Had any significant morbidity:
- 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:
- Had an amputation of any part of the lower limbs except toes, or had an amputation of any toes in the last 30 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Falls prevention intervention including exercise and educational componentsThis 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). | Other | Intervention group |
Primary outcome
Number of Fallers
Time frame: Baseline, Monthly phone call follow-up for 1 year, 12th-month after first intervention session
Evaluation of number of falls in 12 months
4 secondary outcomes
Number of Injurious Fallers
Time frame: Baseline, Monthly phone call follow-up for 1 year, 12th-month after first intervention session
Physical Function
Time frame: Baseline, 3rd-month and 12th-month after first intervention session
Fear of Falling
Time frame: Baseline, 3rd-month and 12th-month after first intervention session
Practice of Falls Prevention Behaviours
Time frame: Baseline, 3rd-month and 12th-month after first intervention session
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 30165053Matchar 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.
- Background: PubMed 28202383Matchar 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.
- Derived from this study: PubMed 39695436Lai 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kok Yang Tan contact
Matchar David Bruce principal investigator
Duke-NUS Graduate Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Falls prevention intervention including exercise and educational components in people with Fall Prevention and Fall Injury, run by Duke-NUS Graduate Medical School at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jing Wen Goh (+65 6601 3889, jingwen_goh@duke-nus.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Fallers (time frame: Baseline, Monthly phone call follow-up for 1 year, 12th-month after first intervention session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06102954, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.