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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Date data sharing statement initially provided
Date results information initially provided
Type of registration
Prospectively registered

Titles & IDs
Public title
Understanding the Falls Experience in People with Intellectual Disability in Western Australia
Scientific title
Investigating the incidence of falls, risk factors and injurious rates and understanding the post-fall experience in older adults with intellectual disability: A prospective observational trial.
Secondary ID [1] 287148 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intellectual Disability
295701 0
Down Syndrome 295702 0
Autism 295703 0
Fragile X 295704 0
Cerebral Palsy 295705 0
Tuberous Sclerosis 295706 0
Angleman Syndrome 295707 0
Condition category
Condition code
Musculoskeletal 295987 295987 0 0
Other muscular and skeletal disorders
Injuries and Accidents 295999 295999 0 0
Other injuries and accidents
Human Genetics and Inherited Disorders 296079 296079 0 0
Other human genetics and inherited disorders

Study type
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Observation of older adults with a primary or secondary diagnosis of Intellectual disability for 6 months.
Participants will be asked to complete a falls diary for 6 months where the rate of falls and injurious falls will be collected. The circumstance surrounding a fall will also be document when a fall occurs over a telephone interview. Participants who fall may also be asked to participate in an interview regarding their post-fall experience.
Intervention code [1] 292415 0
Not applicable
Comparator / control treatment
Control group

Primary outcome [1] 295657 0
Rate of falls
Timepoint [1] 295657 0
6 months from start of trial.
Rate of falls will be assessed with a diary provided to participants and a monthly phone calls for 6 months after enrolment
Secondary outcome [1] 316132 0
Post-fall experience
Timepoint [1] 316132 0
Measured with a face to face interview with a participant and/or their caregiver(s) after a fall to gather qualitative information about what they experienced after the fall such as the care support they received or was offered to them, what services did they access, what activities did they engage to prevent the next fall, did they experience any post-fall related fears, do they perceive any barriers in engaging in falls prevention recommendtations
Secondary outcome [2] 316417 0
Rate of injurious falls
Timepoint [2] 316417 0
A fall is classified as injurious if a participant reports a physical injury as a result of the fall. This is measured with diary collection and phone call for each participant fall.
Secondary outcome [3] 316418 0
Associated Risk factors for falls
Timepoint [3] 316418 0
Measured by demographic data gathered at baseline of age, gender, level of mobility, amount of assistance received at home, BMI and employment status

Key inclusion criteria
Primary or secondary diagnosis of intellectual disability, age 35 years and older, live in the community
Minimum age
35 Years
Maximum age
No limit
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
Only physical ability is to move head and facial muscles with no other involuntary muscle activity eg muscle spasms
Live in residential care facility
Unable to understand English

Study design
Natural history
Defined population
Statistical methods / analysis
Sample size calculation:
The incidence of falls in this population is uncertain but based on previous studies is estimated to be about 0.27. If the expected result is 0.27 we want 95% confidence, within a 1% absolute margin of error that the true incidence rate frequency lies between 0.73 and 1.27. For this we will need a minimum sample size of 78. As the study population has both physical and social disability and the observation periods extends for six months we will allow for a drop out of approximately 15%, which is higher than the 5% allowed for in previous observational falls cohort study of older people, therefore the aim is to recruit 90 participants.

Observational study:
Descriptive statistics will be used to describe the clinical and demographic characteristics of the participants. Falls analyses will follow recommended statistical guidelines for analyzing falls data.
The primary aim: estimate the incidence of falls - this will be expressed as incidence rate per person year (falls rate).

The secondary aims: estimate number of fallers - this will be expressed a percentage of people falling in the cohort.
The rate of injurious fall will be expressed as the incident rate per person year.
Generalized linear mixed modelling will be conducted to examine patient and clinical characteristics predictive of falls, injurious falls and risk of falling in the 6 months after commencement of falls diary.
The modelling strategies will start with unadjusted univariate analysis, followed by multivariate analysis, adjusting for age, severity of intellectual disability, presence or absence of epilepsy, level of assistance required with activities of daily living, level of mobility and a history of falls in the six months prior to enrollment in the study. These variables have been shown to be predictive of falls in either older people with intellectual disability.

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 291717 0
Name [1] 291717 0
The University of Notre Dame Australia
Country [1] 291717 0
Primary sponsor type
The University of Notre Dame Australia
19 Mouat Street (PO Box 1225)
Fremantle, Western Australia
Australia 6959
Secondary sponsor category [1] 290389 0
Commercial sector/Industry
Name [1] 290389 0
Rocky Bay Inc.
Address [1] 290389 0
60 McCabe Street, Mosman Park WA 6012
Country [1] 290389 0

Ethics approval
Ethics application status
Ethics committee name [1] 293239 0
The University of Notre Dame Australia HREC
Ethics committee address [1] 293239 0
19 Mouat St, (PO Box 1225)

Fremantle WA 6959
Ethics committee country [1] 293239 0
Date submitted for ethics approval [1] 293239 0
Approval date [1] 293239 0
Ethics approval number [1] 293239 0

Brief summary
Falls have also been identified as a serious health issue which can cause serious physical injuries and fear of falling. People living with intellectual disability (ID) in residential settings have been reported to have a higher incidence of falls and experience falls at a younger age than the general older population. There are existing comprehensive multi-targeted interventions and services for the older mainstream populations, however, its been reported that there are no suitable falls prevention guidelines or specific services targeting people with ID and their care providers.
The purpose of this study is to gain an understanding of the nature of falls in people with ID and to identify gaps in recommended falls prevention service pathways that people with ID may face. The study will also investigate the barriers that people with intellectual disability may face in engaging in evidence based falls prevention guidelines. This will allow the development of preliminary recommendations for falls prevention that are specifically targeted for people with ID.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 59018 0
Dr Anne-Marie Hill
Address 59018 0
School of Physiotherapy and Exercise Science
Faculty of Health Sciences
Curtin University
GPO Box U1987
Perth, Western Australia, Australia, 6845
Country 59018 0
Phone 59018 0
+61 8 9266 4104
Fax 59018 0
Email 59018 0
Contact person for public queries
Name 59019 0
Miss Portia Ho
Address 59019 0
School of Physiotherapy
The University of Notre Dame Australia
19 Mouat Street, (PO Box 1225)
Fremantle WA 6959
Country 59019 0
Phone 59019 0
+61 0432 984 008
Fax 59019 0
Email 59019 0
Contact person for scientific queries
Name 59020 0
Miss Portia Ho
Address 59020 0
School of Physiotherapy
The University of Notre Dame Australia
19 Mouat Street, (PO Box 1225)
Fremantle WA 6959
Country 59020 0
Phone 59020 0
+61 0432 984 008
Fax 59020 0
Email 59020 0

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

No Supporting Document Provided
Current supporting documents:

Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseInvestigating falls in adults with intellectual disability living in community settings and their experiences of post-fall care services: protocol for a prospective observational cohort study.2018
EmbaseIncidence and associated risk factors for falls in adults with intellectual disability.2019