Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000224628
Ethics application status
Approved
Date submitted
24/02/2014
Date registered
3/03/2014
Date last updated
11/11/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised trial to evaluate the effect of an education program on fall prevention knowledge and the prescription of exercises shown to prevent falls in older people.
Scientific title
A randomised controlled trial to evaluate the effect of an education program on fall prevention knowledge and the prescription of exercises shown to prevent falls in older people by health and exercise professionals.
Secondary ID [1] 283117 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Falls in older age 289965 0
Condition category
Condition code
Injuries and Accidents 290336 290336 0 0
Other injuries and accidents
Public Health 291612 291612 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will be a one-day education workshop that will provide information about the physiology of falls, risk factors for falls and theoretical and practical aspects of the provision of interventions to prevent falls. It will involve didactic and interactive sessions with groups of between 30 and 40 people. Workshop participants will also have access to internet-based resources to assist with prescription of evidence-based fall prevention exercises. The program aims to embed evidence from falls prevention principles and practices into the delivery of community-based exercise programs that aim to prevent falls.
Intervention code [1] 287838 0
Other interventions
Comparator / control treatment
A waiting list control group will be used. People allocated to the control group will receive the education intervention three months after the intervention group.
Control group
Active

Outcomes
Primary outcome [1] 290378 0
Knowledge about fall risk factors and evidence-based interventions to prevent falls. This outcome will be assessed via a self-report questionnaire specifically designed for the study.
Timepoint [1] 290378 0
Three months after randomisation
Primary outcome [2] 293410 0
Self-perceived change in fall prevention exercise prescription behaviour, measured by asking the question “Do you think you have changed the way you prescribe fall prevention exercise in the past three months?”.
Timepoint [2] 293410 0
3 months after randomisation
Secondary outcome [1] 304383 0
The proportion of exercise prescription strategies used in the past month that comply with evidence-based fall prevention guidelines. This outcome will be assessed via a self-report questionnaire.
Timepoint [1] 304383 0
Three months after randomisation
Secondary outcome [2] 305752 0
The proportion of clients aged 60 years and over seen in the past month that were prescribed evidence-based fall prevention exercise. This outcome will be assessed via a self-report questionnaire specifically designed for the study.
Timepoint [2] 305752 0
Three months after randomisation
Secondary outcome [3] 310972 0
Participants’ self-reported confidence to teach evidence-based fall prevention exercises as measured by the question: "How confident are you at prescribing exercises to older people for fall prevention?"
(scored on an 11-point likert scale from 0=least confident to 10=most confident)
Timepoint [3] 310972 0
Three months after randomisation

Eligibility
Key inclusion criteria
Participants will be Health and Exercise Professionals, such as registered Physiotherapists, Occupational Therapists, Nurses, Medical practitioners, Exercise Physiologists and Fitness Leaders whose clientele includes a significant proportion of older people.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
People will be excluded from participation if they are not fluent in written and spoken English

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
To ensure allocation concealment, randomisation to groups will be undertaken by an investigator not involved in recruitment using a computer generated random number schedule with randomly permuted block sizes. Randomisation to intervention or control groups will occur after completion of baseline questionnaires and initial assessment of fall prevention knowledge and exercise prescription behaviour. Allocation will involve contacting the holder of the allocation schedule who will ber at the central administration site and will have no contact with potential participants.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generation will be devised with a computer generated random number schedule with randomly permuted block sizes.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Between-group differences on the knowledge assessment (primary outcome) at follow-up will be analysed with linear regression with study group as the independent variable, knowledge score at follow-up as the dependent variable, baseline score on the knowledge assessment as a covariate. The difference in the proportion of people reporting a change in fall prevention exercise prescription behaviour (primary outcome), between the intervention and control groups will be assessed with the relative risk statistic. Between-group comparisons of the secondary outcomes of a) the proportion of older people seen in the last month for whom balance challenging exercise was prescribed; and b) the proportion of exercises prescribed by participants to older people in the past month that comply with fall prevention guidelines, will be undertaken using the relative risk statistic. An intention-to-treat approach will be used for all analyses.
Sample size calculations indicate that a 20% difference in the proportion of people reporting an increase in exercise prescription behaviour will be detected with a sample size of 220 (control group rate 50%, intervention group rate 70%, power = 80%, alpha = 5%, 15% dropouts). This sample size will also provide 80% power to detect a 20% between-group difference in the proportion of people who improved on the knowledge test at 3 month follow-up (control group rate 50%, intervention group rate 70%, alpha = 5%, 15% dropouts).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/12/2014
Actual
9/02/2015
Date of last participant enrolment
Anticipated
Actual
17/06/2016
Date of last data collection
Anticipated
Actual
3/11/2016
Sample size
Target
220
Accrual to date
Final
200
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 287877 0
Government body
Name [1] 287877 0
National Health and Medical Research Council
Country [1] 287877 0
Australia
Primary sponsor type
Individual
Name
Dr Anne Tiedemann
Address
The George Institute for Global Health
PO Box M201 Missenden Rd
Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 286604 0
Individual
Name [1] 286604 0
Prof Catherine Sherrington
Address [1] 286604 0
The George Institute for Global Health
PO Box M201 Missenden Rd
Camperdown NSW 2050
Country [1] 286604 0
Australia
Secondary sponsor category [2] 287058 0
Individual
Name [2] 287058 0
Dr Daina Sturnieks
Address [2] 287058 0
Neuroscience Research Australia
PO Box 1165 Randwick NSW 2031
Country [2] 287058 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289820 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 289820 0
Ethics committee country [1] 289820 0
Australia
Date submitted for ethics approval [1] 289820 0
Approval date [1] 289820 0
07/09/2012
Ethics approval number [1] 289820 0
15162

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

Contacts
Principal investigator
Name 42558 0
Dr Anne Tiedemann
Address 42558 0
The George Institute for Global Health
PO Box M201, Missenden Rd
NSW 2050
Country 42558 0
Australia
Phone 42558 0
61280524393
Fax 42558 0
Email 42558 0
[email protected]
Contact person for public queries
Name 42559 0
Anne Tiedemann
Address 42559 0
The George Institute for Global Health
PO Box M201, Missenden Rd
NSW 2050
Country 42559 0
Australia
Phone 42559 0
61280524393
Fax 42559 0
61296570301
Email 42559 0
[email protected]
Contact person for scientific queries
Name 42560 0
Anne Tiedemann
Address 42560 0
The George Institute for Global Health
PO Box M201, Missenden Rd
NSW 2050
Country 42560 0
Australia
Phone 42560 0
61280524393
Fax 42560 0
Email 42560 0
[email protected]

No information has been provided regarding IPD availability


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.