Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000926538
Ethics application status
Approved
Date submitted
28/07/2015
Date registered
7/09/2015
Date last updated
1/02/2019
Date data sharing statement initially provided
1/02/2019
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
Nil
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

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
6
Target follow-up type
Months
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
N/A
Control group
Uncontrolled

Outcomes
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

Eligibility
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
Sex
Both males and females
Can healthy volunteers participate?
No
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
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
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
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2015
Actual
1/10/2015
Date of last participant enrolment
Anticipated
30/06/2018
Actual
11/05/2018
Date of last data collection
Anticipated
31/10/2018
Actual
12/12/2018
Sample size
Target
90
Accrual to date
Final
78
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 291717 0
University
Name [1] 291717 0
The University of Notre Dame Australia
Country [1] 291717 0
Australia
Primary sponsor type
University
Name
The University of Notre Dame Australia
Address
19 Mouat Street (PO Box 1225)
Fremantle, Western Australia
Australia 6959
Country
Australia
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
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293239 0
The University of Notre Dame Australia HREC
Ethics committee address [1] 293239 0
Ethics committee country [1] 293239 0
Australia
Date submitted for ethics approval [1] 293239 0
12/05/2015
Approval date [1] 293239 0
20/07/2015
Ethics approval number [1] 293239 0
015067F

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

Contacts
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
Australia
Phone 59018 0
+61 8 9266 4104
Fax 59018 0
Email 59018 0
[email protected]
Contact person for public queries
Name 59019 0
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
Australia
Phone 59019 0
+61 0432 984 008
Fax 59019 0
Email 59019 0
[email protected]
Contact person for scientific queries
Name 59020 0
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
Australia
Phone 59020 0
+61 0432 984 008
Fax 59020 0
Email 59020 0
[email protected]

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



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.2018https://dx.doi.org/10.1186/s12877-018-0862-8
EmbaseIncidence and associated risk factors for falls in adults with intellectual disability.2019https://dx.doi.org/10.1111/jir.12686
N.B. These documents automatically identified may not have been verified by the study sponsor.