Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000917336p
Ethics application status
Help: Ethics application status
Submitted, not yet approved
Date submitted
Help: Date submitted
3/07/2026
Date registered
Help: Date registered
24/07/2026
Date last updated
Help: Date last updated
24/07/2026
Date data sharing statement initially provided
Help: Data sharing statement date
24/07/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Falls-EDU III: A student-led falls prevention program for older adults 55+ delivered through university clinical placements
Scientific title
Falls-EDU III: Longitudinal implementation and evaluation of a student-led falls prevention program embedded within Work Integrated Learning
Additional trial identifiers [1] 317790 0
Nil known
Universal Trial Number (UTN)
U1111-1343-3292
Trial acronym
Falls-EDU III
Related trial records
Falls-EDU III is a follow-on implementation study from Falls-EDU II (ACTRN12626000466347), which itself followed the original Falls-EDU feasibility study (ACTRN12625000740493). Phase 3 embeds the refined student-led falls prevention program within routine osteopathy Work Integrated Learning (WIL) at a University Clinic and evaluates implementation and longitudinal participant outcomes during routine clinical service delivery.

Health condition
Health condition(s) studied:
Falls Risk 342700 0
Condition category
Condition code
Physical Medicine / Rehabilitation 338838 338838 0 0
Other physical medicine / rehabilitation
Musculoskeletal 338839 338839 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 338840 338840 0 0
Physiotherapy
Public Health 338841 338841 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
The Falls-EDU protocol has progressed through sequential phases of development and refinement. Following the successful feasibility (Phase 1) and interprofessional pilot (Phase 2), the approved 8-week protocol will now be embedded within routine osteopathy Work Integrated Learning (WIL) at the RMIT Health Clinic. The intervention remains unchanged from Phase 2 and comprises supervised student-led falls prevention delivered within a university clinical teaching environment. Physiotherapy students may also participate where feasible to support interprofessional learning.

The research component has transitioned from evaluating intervention feasibility to evaluating the implementation, sustainability and longitudinal outcomes of the Falls-EDU program during routine clinical service delivery. Participants who consent to the research will have routinely collected clinical outcome measures, implementation outcomes and participant satisfaction data analysed over an 18-month period.
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Interprofessional education component:

The interprofessional education (IPE) component is delivered through a structured framework in which osteopathy and, where feasible, physiotherapy students engage in asynchronous online microlearning (across multiple formats; i.e., video, short reading, reflective prompts) and synchronous activities, including co-design and delivery of the group falls and balance sessions,, and structured reflection on group-based falls prevention exercise programs. The framework was co-designed by an expert working group (n=10) comprising academics, falls prevention clinicians, and students, and is aligned with the WHO definition of interprofessional education and the IPEC Core Competencies within a falls prevention context.

The IPE component occurs during the intervention period (Weeks 2–7 of the 8-week program). It is delivered weekly as part of scheduled clinic sessions, consisting of between 1-2 hours of facilitated synchronous IPE activities integrated within 3-hour sessions in the clinic. Optional asynchronous online microlearning (5–10 minutes per week) is also provided to support learning.

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The intervention consists of two core components:

1. Falls Risk Screening/Assessment/Stratification
2. Tailored Falls Risk Management

Who delivers the intervention:
Senior (4th/5th year) osteopathy students undertaking Work-Integrated Learning placements, under the direct supervision of experienced registered osteopaths (clinical educators). Physiotherapy students may also participate where feasible under the supervision of registered physiotherapists.

Mode of delivery:
- Face-to-face. There will be 2 x individual consultations within a supervised clinical teaching setting, eight weeks apart apart (week 1 and week 8)
- Group exercise classes: There will be the option of attending up to three group falls and balance exercise classes within a supervised clinical teaching setting in week 3, 5 and 7.
- Additional follow-up one phone call between individual sessions (at around 4 weeks after initial consultation)

Duration/frequency:
- Two x 1-hour in-person consultations in week 1 and week 8.
- Three x supervised 60-minute classes delivered in a supervised clinical teaching setting which includes 5 min welcome, 5 min warm up, 35-40 minute main set, 5 min cool down and 5 min exit (total = 60 mins per session)
- One follow-up phone call four weeks after the initial consultation - approximately 5-10 minutes - to support adherence and address issues with the home exercise program.

INTERVENTION:

(1) Falls Risk Screening/Assessment/Stratification.

a) Screening and Assessment
i. Case history including history of falls and falls risks; medical history
ii. Patient-Reported Outcome Measures (Short FES-I)

b) Assessment:
iii. Physical Performance Measures - QuickScreen© Clinical Falls Risk Assessment; Timed Up and Go (TUG) test

c) Stratification
Using the results from the Falls Risk Screening and Assessment protocol elements (QuickScreen© Clinical Falls Risk Assessment, TUG and falls history) participants will be stratified into one of three risk categories: Low Risk, Intermediate Risk or High Risk.

(2) Management Plan
All participants will receive education and printed resources, a letter of communique to their GP regarding the program and their individual falls risk, and access to up to three supervised, group falls and balance (FAB) exercise classes based on the Otago Exercise Program, delivered in weeks 3, 5 and 7. These classes form part of an integrated intervention that also includes falls risk assessment/stratification, semi-individualised home exercise management (for low- and intermediate-risk participants only), and educational materials. All participants, regardless of risk category, are offered the group FAB classes; however, only low- and intermediate-risk participants receive an additional home exercise program.

Risk-specific components include:

a) Low Risk:
- Education on falls risk factors (https://cdn.activeandhealthy.nsw.gov.au/assets/Healthy-ageing-resources/Falls-prevention.pdf)- e.g., polypharmacy, vision issues (https://cdn.activeandhealthy.nsw.gov.au/assets/Healthy-ageing-resources/Eye-health.pdf), incontinence (https://cdn.activeandhealthy.nsw.gov.au/assets/Healthy-ageing-resources/Bladder-and-bowel-health.pdf), footwear, fear of falling.
- Flyers:
>> home safety checklist (https://www.cdc.gov/steadi/pdf/steadi-brochure-checkforsafety-508.pdf), >> get-up-from-floor technique (https://www.injurymatters.org.au/wp-content/uploads/2021/06/Up-Off-The-Floor-Arms-and-Knees.pdf)
>> footwear checklist (https://www.cec.health.nsw.gov.au/__data/assets/pdf_file/0011/258536/Falls-Prevention-Foot-Care-and-Footwear.pdf)
- Self-monitoring exercise diary for home exercise program
- Semi-individualised Modified Otago Exercise Program (OEP) as a home program (e.g. strength exercises sit-to-stand, heel and toe raises; and balance exercises such as tandem stand, one leg stand).*

*>> Individualisation is informed by each participant’s falls risk stratification (low or intermediate risk) based on screening and assessment results, including the QuickScreen© Clinical Falls Risk Assessment, TUG, and a brief functional history. Students, under clinical supervision, will assess each participant’s functional capacity and select a maximum of 2 lower limb strength and 2 balance exercises from the modified OEP menu that are safe and appropriate for home use. The exercises and prescription is based off level A and B of the OEP, and have deliberately been chosen to suit a student-led, feasibility trial format within a clinical education setting.
>> Mode of administration: face-to-face, with the osteopathy and allied health students (under clinical supervision) prescribing a home-based exercise program for the participant to complete independently at home. This occurs in consultation 1 (baseline). Then participants can choose to complete the exercises at home. The student team will conduct a follow-up telephone call to the participant at 4 weeks to check in and see if the participants have any questions/ challenges with the home exercises. At the second individual consultation (week 8), the student team will run through the previously prescribed exercises with the participant, and then make an informed decision (under clinical supervision) about whether to progress the participant in terms of repetitions, sets or other exercises.
>> Intensity: Low to moderate, assessed informally via functional performance and self-reported exertion.
>> Frequency: Participants will be recommended to perform their prescribed exercises up to 2-3 times per week.
>> Duration: The program runs over an 8-week period.
>> Monitoring adherence: A self-monitoring exercise diary is provided to track completion. It will also be discussed during a follow-up phone call at week 4 and reviewed again during the second clinic visit at week 8.

- GP letter suggesting periodic monitoring and other recommendations as per the World Falls Guidelines (such as onward referral, if required).

b) Intermediate Risk:
- Includes all low-risk strategies
- Additional recommendation in GP letter to continue OEP for 12 months, preferably under allied health supervision. This recommendation is up to the GP and patient to organise.

c) High Risk:
- Education materials only – no home exercise prescribed due to safety concerns and risk mitigation in a student clinic setting
- GP letter strongly recommending further multidisciplinary assessment
- Example referrals: physiotherapist, exercise physiologist, falls clinics (e.g. community Falls and Balance Service or similar). To be organised by the GP within the patient's local setting and within their care preferences.

d) Non-risk based management (i.e., ALL participants):
Non–risk-based management (i.e. all participants) will also include the option to attend up to three supervised 60-minute group falls and balance classes in weeks 3, 5 and 7. These Otago-based classes follow a standardised format (welcome, warm up, strength and balance block, cool down, closing discussion) and typically include lower limb strengthening (e.g. sit-to-stand, mini squats, heel and toe raises, hip abduction, step-ups), static balance tasks (e.g. feet together, tandem and single-leg stance, with optional head turns), and dynamic/reactive balance tasks (e.g. forward/backward and side stepping, tandem walking, heel/toe walking, marching on the spot, light perturbations, step-and-reach tasks).

The design of each class is co-produced by the students with oversight from the clinical educator in the week prior to delivery. Session planning explicitly considers which participants are expected to attend and their falls risk classification, to allow appropriate exercise progressions and regressions and to ensure safety. Classes are delivered in a supervised clinical teaching setting with up to six older adults per group, two students leading the session and one clinical educator providing oversight.

Note regarding the Home Exercise Program and the Group Exercise classes: The home exercise program and supervised group classes are both based on the OEP; however, they are not identical. The home exercise program is semi-individualised and prescribed only to participants classified as low or intermediate falls risk, with exercises selected according to functional ability and safety considerations for independent completion at home. In contrast, the supervised group classes utilise a broader range of OEP-based strength, balance and mobility exercises that can be safely delivered under direct student and clinician supervision. These supervised sessions also enable progression, regression and inclusion of higher-level balance tasks and are offered to all participants, including those classified as high risk, due to the additional safety and quality assurance provided by the supervised clinical environment.

Monitoring adherence:
- Face-to-face session attendance checklist - both individual and group exercise classes
- Telephone call attendance
- Exercise diary (self-monitoring) for home exercise program

Implementation and longitudinal evaluation: As the Falls-EDU program is now embedded within routine WIL placements, participants who provide research consent will contribute routinely collected clinical outcome measures, implementation outcomes (including service delivery and program integration) and participant satisfaction data. Data will be collected continuously over an 18-month implementation period to evaluate the sustainability and integration of the program within routine clinical practice.
Intervention code [1] 334632 0
Prevention
Description of the comparator or control
No comparator or control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 346046 0
Implementation: Reach
Timepoint [1] 346046 0
Continuously throughout the 18-month implementation period; analysed at study completion (18 months)
Primary outcome [2] 346047 0
Implementation: Adoption
Timepoint [2] 346047 0
Continuously throughout the 18-month implementation period; analysed at study completion (18 months)
Primary outcome [3] 346048 0
Implementation
Timepoint [3] 346048 0
Throughout intervention delivery; CSQ-8 at Week 8; summarised at 18 months
Secondary outcome [1] 464428 0
Fear of falling
Timepoint [1] 464428 0
Baseline (prior to intervention commencement) and approximately 8 weeks following intervention commencement.
Secondary outcome [2] 464429 0
Falls risk
Timepoint [2] 464429 0
Baseline (prior to intervention commencement) and approximately 8 weeks following intervention commencement.
Secondary outcome [3] 464430 0
Mobility
Timepoint [3] 464430 0
Baseline (prior to intervention commencement) and approximately 8 weeks following intervention commencement.
Secondary outcome [4] 464431 0
Participant satisfaction
Timepoint [4] 464431 0
approximately 8 weeks following intervention commencement.
Secondary outcome [5] 464432 0
Home exercise adherence
Timepoint [5] 464432 0
Approximately 4 weeks following intervention commencement and approximately 8 weeks following intervention commencement.
Secondary outcome [6] 464433 0
Group class attendance
Timepoint [6] 464433 0
Throughout the 8-week program

Eligibility
Key inclusion criteria
1. written informed consent to participate
2. adults aged 55 years and over
3. must be living in the community (including independent living communities)
Minimum age
55 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
Yes
Key exclusion criteria
1. permanent resident of a hospital, residential aged care facility, rehabilitation center, or other long-term care facility
2. insufficient English language proficiency to understand the participant information and consent form or to engage in the intervention and/or research procedures without the use of an interpreter
3. currently participating in, or having completed within the past three months, another structured falls prevention program
4. primarily non-ambulant e.g. using a wheelchair
5. neuromuscular or musculoskeletal conditions significantly affecting gait or balance (e.g., Parkinson’s disease, lower limb amputees)
6. recent surgery within the past 12 weeks
7. Lower limb or vertebral fracture in the previous 6 months
8. physician diagnosed, or patient reported, severe osteoporosis (defined by the World Health Organisation as a T score at or below –2.5 with the presence of one or more fractures)
9. Severe cognitive impairment that includes diagnosed conditions such as dementia, stroke with cognitive sequelae, or recent head trauma resulting in cognitive dysfunction, as self-reported or noted by carers or health professionals.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Implementation outcomes will be analysed using the RE-AIM framework. Reach, adoption, implementation and maintenance outcomes will be summarised using descriptive statistics, including frequencies, proportions, means, standard deviations and medians/interquartile ranges where appropriate. Data sources will include clinic records, recruitment and consent logs, Work-Integrated Learning placement records, fidelity checklists, attendance records and participant satisfaction data.

Reach will be assessed through referral numbers, eligibility, enrolment, consent rates and participant characteristics. Adoption will be assessed by the number of placement blocks, students and clinical educators involved in program delivery. Implementation will be assessed through attendance, completion of protocol components, fidelity to the approved Falls-EDU protocol, GP letter completion, follow-up phone call completion, home exercise adherence and Client Satisfaction Questionnaire (CSQ-8) scores. Maintenance will be assessed through continued delivery across the 18-month implementation period and integration within routine clinic and WIL processes.

Clinical outcomes, including Timed Up and Go (TUG), QuickScreen Clinical Falls Risk Assessment and Short FES-I, will be collected at baseline and Week 8. Pre–post changes will be analysed using paired t-tests or non-parametric equivalents where assumptions are not met. Statistical significance will be set at p<0.05, with 95% confidence intervals reported where appropriate.

Findings will be used to evaluate the implementation, sustainability and ongoing refinement of the Falls-EDU program embedded within routine WIL.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
29/07/2026
Actual
Date of last participant enrolment
Anticipated
1/11/2027
Actual
Date of last data collection
Anticipated
31/01/2028
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 322336 0
University
Name [1] 322336 0
RMIT University
Country [1] 322336 0
Australia
Primary sponsor type
University
Name
RMIT University
Address
Country
Australia
Secondary sponsor category [1] 325253 0
None
Name [1] 325253 0
Address [1] 325253 0
Country [1] 325253 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 320839 0
Royal Melbourne Institute of Technology Human Research Ethics Committee
Ethics committee address [1] 320839 0
Ethics committee country [1] 320839 0
Australia
Date submitted for ethics approval [1] 320839 0
03/07/2026
Approval date [1] 320839 0
Ethics approval number [1] 320839 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 151798 0
Dr Danielle Baxter
Address 151798 0
RMIT University, School of Health and Biomedical Sciences Level 4, Bundoora, VIC 3083
Country 151798 0
Australia
Phone 151798 0
+61 03 99257647
Fax 151798 0
Email 151798 0
[email protected]
Contact person for public queries
Name 151799 0
Danielle Baxter
Address 151799 0
RMIT University, School of Health and Biomedical Sciences Level 4, Bundoora, VIC 3083
Country 151799 0
Australia
Phone 151799 0
+61 03 99257647
Fax 151799 0
Email 151799 0
[email protected]
Contact person for scientific queries
Name 151800 0
Danielle Baxter
Address 151800 0
RMIT University, School of Health and Biomedical Sciences Level 4, Bundoora, VIC 3083
Country 151800 0
Australia
Phone 151800 0
+61 03 99257647
Fax 151800 0
Email 151800 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.