Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000740493
Ethics application status
Approved
Date submitted
27/04/2025
Date registered
15/07/2025
Date last updated
15/07/2025
Date data sharing statement initially provided
15/07/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
FALLS-EDU: Feasibility of a Student-Led Falls Prevention and Education Program for Community-Dwelling Older Adults in a University Health Clinic Setting
Scientific title
FALLS-EDU: Feasibility of a Student-Led Falls Prevention and Education Program for Community-Dwelling Older Adults in a University Health Clinic Setting
Secondary ID [1] 314298 0
nil
Universal Trial Number (UTN)
n/a
Trial acronym
FALLS-EDU
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Falls risk 337239 0
Condition category
Condition code
Musculoskeletal 333648 333648 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 333649 333649 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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 under the direct supervision of experienced, registered osteopaths (clinical educators) at the university clinical teaching setting

Mode of delivery:
Face-to-face, one-on-one consultations within a supervised clinical teaching setting, one month apart.
Additional follow-up one phone call between sessions (at around 2 weeks after initial consultation)

Duration/frequency:
- Two x 1-hour in-person consultations over 4 weeks
- One follow-up phone call two weeks after the initial consultation - approximately 5-10 minutes

INTERVENTION:

(1) Falls Risk Screening/Assessment/Stratification.

a) Screening and Assessment
i. Case history including history of falls and falls risks
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. 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.pd ), >> 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 diary
- Semi-individualised Modified Otago Exercise Program (OEP) (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. Senior student osteopaths, 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 senior student osteopath team (under clinical supervision) prescribing a home-based 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 2 weeks to check in and see if the participants have any questions/ challenges with the home exercises. At the second consultation (week 4), 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 a 4-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 2 and reviewed again during the second clinic visit at week 4.

- GP letter suggesting periodic monitoring

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.

Monitoring adherence:
- Face-to-face session attendance checklist
- Telephone call attendance
- Exercise diary (self-monitoring)
Intervention code [1] 330911 0
Prevention
Intervention code [2] 330912 0
Early detection / Screening
Comparator / control treatment
No comparator or control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 341231 0
Feasibility of the FALLS-EDU intervention (composite outcome)
Timepoint [1] 341231 0
Assessed over the 4-week duration of each participant's involvement.
Primary outcome [2] 341233 0
Feasibility of the research procedures (composite outcome)
Timepoint [2] 341233 0
Assessed throughout the duration of the feasibility trial, with final evaluation following data collection and study close-out.
Primary outcome [3] 342044 0
Acceptability of the intervention (falls prevention program)
Timepoint [3] 342044 0
Focus groups will be conducted within 2–6 weeks following the completion of data collection for the intervention phase.
Secondary outcome [1] 446847 0
Short Falls Efficacy Scale International (Short FES-I)
Timepoint [1] 446847 0
Baseline and end of program (week 0 and week 4)
Secondary outcome [2] 449410 0
QuickScreen® Clinical Falls Risk Assessment
Timepoint [2] 449410 0
Baseline and end of program (week 0 and week 4)
Secondary outcome [3] 449411 0
Timed Up and Go (TUG) test
Timepoint [3] 449411 0
Baseline and end of program (week 0 and week 4)

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
Can healthy volunteers participate?
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
To evaluate the feasibility of the student-led falls prevention program, several quantitative metrics will be collected and analysed. Recruitment and retention rates will be calculated by comparing the number of participants enrolled and retained throughout the study against the target sample size. Attendance at scheduled consultations will be monitored, with attendance rates determined by calculating the proportion of attended sessions relative to those scheduled. Protocol adherence will be assessed by tracking the completion rates of all elements within each one-hour consultation and recording the time taken to complete the semi-individualised protocol. Descriptive statistics, including means, and standard deviations, will summarise participant characteristics in addition to the above metrics.

Operational feasibility will be evaluated by documenting resources utilised, such as personnel, equipment, and materials, along with associated costs, to perform a cost analysis of the program.

For preliminary clinical impact, changes in participants' mobility and fall risk will be assessed using the TUG test and the QuickScreen Falls Risk Assessment. Both of these assessments will be administered at baseline and post-intervention, with paired t-tests used to compare pre- and post-intervention scores, assuming normal distribution. Statistical significance will be determined at an alpha level of 0.05, and 95% confidence intervals will be reported for all estimates.

Qualitative data will be collected through semi-structured focus groups with three stakeholder groups: older adult participants, student clinicians, and clinic staff. These focus groups will explore participant satisfaction, program acceptability, overall experiences and recommendations for future programs.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
21/07/2025
Actual
Date of last participant enrolment
Anticipated
14/11/2025
Actual
Date of last data collection
Anticipated
24/12/2025
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 318816 0
University
Name [1] 318816 0
RMIT University
Country [1] 318816 0
Australia
Primary sponsor type
University
Name
RMIT University
Address
Country
Australia
Secondary sponsor category [1] 321263 0
None
Name [1] 321263 0
Address [1] 321263 0
Country [1] 321263 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317430 0
Royal Melbourne Institute of Technology Human Research Ethics Committee
Ethics committee address [1] 317430 0
Ethics committee country [1] 317430 0
Australia
Date submitted for ethics approval [1] 317430 0
28/04/2025
Approval date [1] 317430 0
10/07/2025
Ethics approval number [1] 317430 0
29055

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

Contacts
Principal investigator
Name 141018 0
Dr Danielle Baxter
Address 141018 0
RMIT University, School of Health and Biomedical Sciences Level 4, Bundoora, VIC 3083
Country 141018 0
Australia
Phone 141018 0
+61 03 99257647
Fax 141018 0
Email 141018 0
[email protected]
Contact person for public queries
Name 141019 0
Danielle Baxter
Address 141019 0
RMIT University, School of Health and Biomedical Sciences Level 4, Bundoora, VIC 3083
Country 141019 0
Australia
Phone 141019 0
+61 03 99257647
Fax 141019 0
Email 141019 0
[email protected]
Contact person for scientific queries
Name 141020 0
Danielle Baxter
Address 141020 0
RMIT University, School of Health and Biomedical Sciences Level 4, Bundoora, VIC 3083
Country 141020 0
Australia
Phone 141020 0
+61 03 99257647
Fax 141020 0
Email 141020 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: This is a feasibility study and not making specific assertions about the therapeutic intervention, thus IPD will not be specifically available.



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.