Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001120763
Ethics application status
Approved
Date submitted
13/07/2022
Date registered
15/08/2022
Date last updated
15/08/2022
Date data sharing statement initially provided
15/08/2022
Date results information initially provided
15/08/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Falls screening mobile application (FallSA©): its discriminative ability, predictive validity and its effectiveness on falls prevention behaviour and physical function among older adults
Scientific title
Falls screening mobile application (FallSA©): its discriminative ability, predictive validity and its effectiveness on falls prevention behaviour and physical function among older adults
Secondary ID [1] 307546 0
NIL
Universal Trial Number (UTN)
Trial acronym
FallSA (Falls Screening Mobile Application)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Falls 326980 0
Condition category
Condition code
Public Health 324170 324170 0 0
Health promotion/education
Physical Medicine / Rehabilitation 324171 324171 0 0
Physiotherapy
Injuries and Accidents 324284 324284 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
FallSA©. The participants who were allocated into experimental group were invited for the group discussion session in a group of 8. Each session took up approximately 90 minutes to complete. During this session, they were given detailed explanation and instructions on how to use FallSA© and they received the installation of FallSA© by the researcher. After that, the participants were given the education with a booklet and video presentation which has been specifically designed for this study. The participants were required to assess and monitor fall risk by themselves at Pusat Aktiviti Warga Emas (PAWE) through the use of FallSA©. The participants were required to complete the physical test (Timed-up and go test) and short questionnaires through the app relating to their fall risk monthly. They were given a recording diary to record the results of FallSA© monthly for a duration of 6 months. In order to ensure their compliance, the researcher gave a phone call to the participants monthly, to remind them to adhere to the guidelines given in falls prevention education pamphlet and video, and to collect the feedback between the study periods, such as the information about the accessibility of FallSA©, results of FallSA© and any falls incidence occur in between.
Intervention code [1] 324011 0
Behaviour
Intervention code [2] 324012 0
Early detection / Screening
Intervention code [3] 324013 0
Prevention
Comparator / control treatment
Group education session. The contents of group education session were similar in both control and experimental group. The participants were given the education with a booklet and video presentation which has been specifically designed for this study. The participants who were allocated into control group were invited for the group discussion session in a group of 8. The session was conducted by researcher and each session took up approximately 50 minutes to complete.
Control group
Active

Outcomes
Primary outcome [1] 331989 0
Falls prevention awareness and practice of falls prevention behavior (this will be assessed as a composite outcome) assessed by Falls Behavioral scale (FaB).
Timepoint [1] 331989 0
Baseline (pre-intervention) and 6 months post-commencement of intervention.
Primary outcome [2] 331990 0
Fall risk knowledge assessed by the Fall Risk Assessment Questionnaire (FRAQ)
Timepoint [2] 331990 0
Baseline (pre-intervention) and 6 months post-commencement of intervention.
Secondary outcome [1] 411847 0
Balance confidence assessed by Activity Specific Balance Confidence Scale-16 (ABC-16)
Timepoint [1] 411847 0
Baseline (pre-intervention) and 6 months post-commencement of intervention.
Secondary outcome [2] 411848 0
Physical function assessed by Short Physical Performance Battery (SPPB)
Timepoint [2] 411848 0
Baseline (pre-intervention) and 6 months post-commencement of intervention.
Secondary outcome [3] 411849 0
Physical activity assessed by Short Physical Performance Battery (SPPB)
Timepoint [3] 411849 0
Baseline (pre-intervention) and 6 months post-commencement of intervention.
Secondary outcome [4] 411850 0
Fall Risk assessed using data collected from FallSA©
Timepoint [4] 411850 0
Baseline (pre-intervention) and 6 months post-commencement of intervention.

Eligibility
Key inclusion criteria
• Older adults aged 60 years and above
• At risk of falls (FallSA©: cut off point of greater than 4)
• Ambulating independently with or without assistive devices
• Able to use mobile phone apps (older adults or caregivers)
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Unable to comprehend and follow instructions
• Medical conditions such as musculoskeletal disorders (fractures of extremities, acute knee pain, any history of hip or knee replacement), malignancy and others condition which may cause some safety issues for the participant to perform the balance and strength tests
• Self- reported functional limitation such as unable to stand up without support, unable to walk without assistive devices
• Severe vision or hearing problems
• Cognitive impairments such as dementia, depression
• Older adults with depression (Geriatric Depression scale (GDS): cut off point of greater than 5)
• Older adults with moderate to severe cognitive impairment (Mini Mental State Examination (MMSE): cut off point of less than 22)
• Unable to use mobile apps

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)
Allocation concealed by central randomization by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The statistical test of mixed- model ANOVA repeated measures (ANCOVA) adjusted for age, genders and years of education was used to identify the significant difference in the effect of empowering community dwelling older adults to self-screen for fall risk using falls screening mobile application (FallSA©). The covariates and confounding factors for the repeated measure analysis were selected from baseline variables which appeared significant at the baseline analysis.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/09/2020
Date of last participant enrolment
Anticipated
Actual
14/09/2020
Date of last data collection
Anticipated
Actual
31/03/2021
Sample size
Target
60
Accrual to date
Final
59
Recruitment outside Australia
Country [1] 24892 0
Malaysia
State/province [1] 24892 0
Kuala Lumpur and Selangor

Funding & Sponsors
Funding source category [1] 311819 0
University
Name [1] 311819 0
Universiti Kebangsaan Malaysia.
Country [1] 311819 0
Malaysia
Funding source category [2] 311828 0
Government body
Name [2] 311828 0
Ministry of Education
Country [2] 311828 0
Malaysia
Primary sponsor type
Government body
Name
Ministry of Education
Address
Level 5, Menara Prisma, No. 26, Jalan Persiaran Perdana Precint 3, 62675 Putrajaya, Malaysia.
Country
Malaysia
Secondary sponsor category [1] 313294 0
University
Name [1] 313294 0
Universiti Kebangsaan Malaysia.
Address [1] 313294 0
Jalan Raja Muda Abdul Aziz 50300 Kuala Lumpur Wilayah Persekutuan Kuala Lumpur.
Country [1] 313294 0
Malaysia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311264 0
Universiti Kebangsaan Malaysia Research Ethics Committee
Ethics committee address [1] 311264 0
Jalan Raja Muda Abdul Aziz 50300 Kuala Lumpur Wilayah Persekutuan Kuala Lumpur.
Ethics committee country [1] 311264 0
Malaysia
Date submitted for ethics approval [1] 311264 0
28/09/2018
Approval date [1] 311264 0
28/09/2018
Ethics approval number [1] 311264 0
UKM PPI/111/8/JEP-2018-559

Summary
Brief summary
The result of the study is important as it will determine whether FallSA© is able to discriminate fallers and predict falls among the community dwelling older adults; and to determine the effects of empowerment on older adult's awareness, practice of falls prevention behaviors, fall risk knowledge, balance confidence and physical function with the use of falls screening mobile application (FallSA©). It will also provide information of the feasibility and current limitations in FallSA© for its upgrade to FallSA 2.0. FallSA© has significant empowering effect on older adults’ awareness, practice of falls prevention behaviors, fall risk knowledge, balance confidence and physical function with the use of falls screening mobile application (FallSA©).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 120498 0
Miss Goh Jing Wen
Address 120498 0
Faculty of Health Sciences, Universiti Kebangsaan Malaysia. Jalan Raja Muda Abdul Aziz 50300 Kuala Lumpur Wilayah Persekutuan Kuala Lumpur.
Country 120498 0
Malaysia
Phone 120498 0
+60176407200
Fax 120498 0
Email 120498 0
wen13118@hotmail.com
Contact person for public queries
Name 120499 0
Miss Goh Jing Wen
Address 120499 0
Faculty of Health Sciences, Universiti Kebangsaan Malaysia. Jalan Raja Muda Abdul Aziz 50300 Kuala Lumpur Wilayah Persekutuan Kuala Lumpur.
Country 120499 0
Malaysia
Phone 120499 0
+60176407200
Fax 120499 0
Email 120499 0
wen13118@hotmail.com
Contact person for scientific queries
Name 120500 0
Miss Goh Jing Wen
Address 120500 0
Faculty of Health Sciences, Universiti Kebangsaan Malaysia. Jalan Raja Muda Abdul Aziz 50300 Kuala Lumpur Wilayah Persekutuan Kuala Lumpur.
Country 120500 0
Malaysia
Phone 120500 0
+60176407200
Fax 120500 0
Email 120500 0
wen13118@hotmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not decided yet.
No platform to share publically.


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.