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Trial registered on ANZCTR


Registration number
ACTRN12625000165482p
Ethics application status
Submitted, not yet approved
Date submitted
11/09/2024
Date registered
12/02/2025
Date last updated
12/02/2025
Date data sharing statement initially provided
12/02/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of a Nurse-Led Fall Prevention Program in Reducing Fall Incidence Among Elderly Patients in a Hospital Ward: A Randomized Controlled Trial
Scientific title
Effectiveness of a Nurse-Led Fall Prevention Program in Reducing Fall Incidence Among Elderly Patients in a Hospital Ward: A Randomized Controlled Trial
Secondary ID [1] 312946 0
NIL
Universal Trial Number (UTN)
U1111-1313-1978
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
falls among elderly patients 335121 0
Condition category
Condition code
Injuries and Accidents 331620 331620 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Falls Prevention Program Details
1. Frequency and Duration of Supervised Balance and Strength Exercises:

The supervised balance and strength exercises will be conducted twice daily for 10 minutes each session during the patient’s inpatient admission. The sessions will be held once in the morning and once in the afternoon to allow for optimal patient engagement without causing fatigue.
2. Examples of Balance and Strength Exercises:

Balance Exercises:
Nurses who have undergone the study-specific training (as described in the Nurse Training Description) will supervise the balance and strength exercises.
Heel-to-toe walk: walking in a straight line with one foot directly in front of the other, mimicking a tightrope walk.
Single-leg stands: standing on one foot for a set time (e.g., 10-15 seconds) and switching to the other foot.
Side leg raises: lifting one leg to the side while holding onto a stable surface for support.
Strength Exercises:
Sit-to-stand: Moving from a seated to a standing position without using hands for support.
Chair squats: Squatting down to just above a chair seat and standing back up.
Heel raises: lifting the heels off the ground while standing to strengthen the calf muscles.
3. Examples of Prevention Strategies for Participants (Education Component):
The CDC STEADI (Stopping Elderly Accidents, Deaths & Injuries) brochure is a concise and well-designed resource for older adults, covering key aspects of fall prevention.(https://www.cdc.gov/steadi/pdf/STEADI-Brochure-WhatYouCanDo-508.pdf)

The American Academy of Orthopaedic Surgeons (AAOS) brochure offers comprehensive information on fall risks, prevention strategies, and home safety tips.(https://orthoinfo.aaos.org/globalassets/pdfs/aaosfallprevention.pdf)

These are exactly the type of publicly available brochures that would be valuable additions to a falls prevention program. When using them in your program, you'll want to clearly cite the source in your materials. If you are modifying them in any way, be sure to get appropriate permissions if necessary.


Environment safety: Advise participants to remove trip hazards such as loose rugs, use non-slip mats in bathrooms, and ensure good lighting throughout their living areas.
Assistive devices: Educate participants on the correct use of walking aids such as canes or walkers.
Footwear: Encourage the use of well-fitting, non-slip shoes, and discourage walking in socks or slippers that may increase the risk of slipping.
Medication review: Advise participants to speak with their healthcare provider about reviewing medications that may contribute to dizziness or instability.
4. Anticipated Duration of the Education Component:

The education component will consist of a once-off education session delivered over a 20-minute period. During this session, participants will receive verbal instructions along with written brochures outlining key prevention strategies and exercises to perform at home. This session will also include demonstrations of the exercises and time for questions.
5. Fall Risk Assessment Description:

The fall risk assessment will involve evaluating the participant’s balance, gait, and strength using tools like the Timed Up and Go Test (TUG) and Berg Balance Scale. Nurses will assess the patient’s mobility, use of assistive devices, and environmental hazards. This assessment will take approximately 10-15 minutes each day and will be recorded in the patient’s care plan to monitor progress and make adjustments to the intervention as needed.
6. Program Duration:

The falls prevention program will be delivered over a 6-month period, starting from the first participant's enrolment. Each participant will be enrolled for the duration of their inpatient stay, and follow-up may continue for one month after discharge to assess outcomes and adherence.
7. Strategies to Monitor Adherence:

Education session attendance checklists will be maintained to ensure participants attend the prevention strategy discussions.
Audit of environmental modifications (e.g., removal of trip hazards, installation of safety equipment) will be conducted during inpatient stays.
Exercise logs will be used for participants to document their completion of supervised and independent exercises. Nurses will check and encourage adherence during daily interactions.
Nurse Training Description
Training for Nurses:

Nurses involved in the program will undergo a comprehensive training session before the program's first participant enrolment. This training will last one week and will cover:

Proper administration of fall risk assessments (e.g., TUG and Berg Balance Scale).
Demonstration and supervision of balance and strength exercises.
Effective communication techniques for patient education on fall prevention strategies.
Documentation procedures to monitor adherence and participant progress.
Clinical supervisors and physiotherapists with expertise in fall prevention and rehabilitation will deliver the training. Ongoing supervision will be provided, and nurses will have access to resources and refresher courses throughout the program to ensure consistency and competency.
Intervention code [1] 329478 0
Prevention
Comparator / control treatment
placebo
routine hospital care, e.g. fall risk screening, patient assistance if required.
On-duty nurses will deliver the routine care for those who need it.
patient will be informed for the assistance at the time of admission if they need any assistance regarding fall.
Control group
Active

Outcomes
Primary outcome [1] 339351 0
Incidence of falls
Timepoint [1] 339351 0
weekly assessment till 6 month post-randomization
Secondary outcome [1] 439617 0
o injuries

Timepoint [1] 439617 0
weekly assessment till 6 month post-randomization

Eligibility
Key inclusion criteria
o Patients aged =greater or equal to 60 years.
o Admitted to the hospital ward for at least 48 hours.
o Able to walk with or without assistance.
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
o Patients with severe cognitive impairments (e.g., dementia).
o Bedridden patients.
o Patients receiving palliative care.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be randomly assigned (1:1) to the intervention or control group using a computer-generated randomization sequence. Allocation will be concealed using opaque sealed envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer based on https://randomizer.org/
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2025
Actual
Date of last participant enrolment
Anticipated
30/04/2025
Actual
Date of last data collection
Anticipated
30/06/2025
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment outside Australia
Country [1] 26555 0
Pakistan
State/province [1] 26555 0
khyber pakhtunkhwa

Funding & Sponsors
Funding source category [1] 317381 0
University
Name [1] 317381 0
khyber medical university
Country [1] 317381 0
Pakistan
Primary sponsor type
University
Name
khyber medical university
Address
Country
Pakistan
Secondary sponsor category [1] 319671 0
None
Name [1] 319671 0
Address [1] 319671 0
Country [1] 319671 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316110 0
Scientific Review Board (SRB) and Institutional Review Board (IRB) of Khyber medical university
Ethics committee address [1] 316110 0
F1 Phase-6 Rd, Phase 5 Hayatabad, Peshawar, Khyber Pakhtunkhwa 25100
Ethics committee country [1] 316110 0
Pakistan
Date submitted for ethics approval [1] 316110 0
08/09/2024
Approval date [1] 316110 0
Ethics approval number [1] 316110 0

Summary
Brief summary
Falls among elderly patients in hospital settings are a major cause of injury, prolonged hospital stays, and increased healthcare costs. Preventing falls is critical, and various programs have been introduced. Nurse-led fall prevention programs, which include patient education, environmental modifications, and exercise interventions, may offer a more tailored and patient-centered approach. However, the effectiveness of these programs compared to standard care needs further evaluation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 136818 0
Mr Tariq Rahim
Address 136818 0
block 12 flat 6 Saudi housing society Ayub teaching hospital Abbottabad
Country 136818 0
Pakistan
Phone 136818 0
+923113196950
Fax 136818 0
Email 136818 0
[email protected]
Contact person for public queries
Name 136819 0
tariq rahim
Address 136819 0
block 12 flat 6 Saudi housing society Ayub teaching hospital Abbottabad
Country 136819 0
Pakistan
Phone 136819 0
+923113196950
Fax 136819 0
Email 136819 0
[email protected]
Contact person for scientific queries
Name 136820 0
Tariq Rahim
Address 136820 0
block 12 flat 6 Saudi housing society Ayub teaching hospital Abbottabad
Country 136820 0
Pakistan
Phone 136820 0
+923113196950
Fax 136820 0
Email 136820 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No; IPD and related data dictionaries will not be made publicly available.
Reason: The data contains sensitive participant information that could compromise confidentiality, and ethical or legal restrictions prevent its sharing. Additionally, the data is part of ongoing research, and sharing it at this stage could impact future studies. Moreover, insufficient resources are available to properly curate the data for public access while ensuring privacy and compliance with regulations.


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.