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Trial registered on ANZCTR
Registration number
ACTRN12615000784516
Ethics application status
Approved
Date submitted
9/07/2015
Date registered
29/07/2015
Date last updated
10/03/2020
Date data sharing statement initially provided
10/03/2020
Date results provided
10/03/2020
Type of registration
Prospectively registered
Titles & IDs
Public title
Tailored Patient Education for Preventing Falls after Hospital Discharge
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Scientific title
Evaluating the effect of providing tailored patient education for older people at hospital discharge in addition to usual care on rates of falls after hospital discharge compared to providing a social intervention in addition to usual care – a randomised controlled trial
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Secondary ID [1]
286956
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Nil known
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Universal Trial Number (UTN)
U1111-1169-4492
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Accidental falls
295408
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Functional ability
295409
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Health related quality of life
295410
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Condition category
Condition code
Injuries and Accidents
295665
295665
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0
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Other injuries and accidents
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Physical Medicine / Rehabilitation
295666
295666
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0
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Other physical medicine / rehabilitation
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Multimedia falls prevention education with between 2 and 4 individual health professional follow-up sessions for each participant in the week prior to hospital discharge. Delivered by physiotherapist who is the educator. Each participant in the intervention group to receive education individually by being shown a DVD and also being given written materials with workbook. The DVD and written materials contain information about falls prevention in the post discharge period, including information about the risk factors for older adults for falls, falls interventions for older adults, addressing individual risk factors, vision for falls prevention, home modifications, use of gait aids, exercise for falls prevention, benefits of exercise for strength and balance, problems encountered that could lead to falls in the post discharge period. Materials are discussed with educator, with participants assisted to develop goals for discharge. The education is based on evidence for falls prevention in the post discharge period. Participant receives individual tailored discussion and feedback that allows them to develop goals and strategies depending on their falls risk and individual medical conditions. Participants are asked to read the workbook which varies according to the reading ability of the participant. An estimated time is 15 minutes. participants are allowed to rewatch the DVD if they wish. participants are encouraged to write and make notes in their workbook and if unable to write are assisted to make notes that are relevant to their situation. This will vary between participants but the total median time is described below. this has been determined by the piloting of the intervention.
Between 2 and 4 meetings will occur and most usually one meeting per day. Each meeting time is estimated to be a maximum of 15 minutes and may range from 10 to 25 minutes. The number of intervention sessions and the time for each session and the total amount of intervention time is determined by clinician assessment of participant. An approximate median time of 45 minutes per patient is estimated. No group activities.
Once per month for three months after participants leave hospital those participants in the intervention group receive a coaching telephone call from the educator (the same physiotherapist), which uses active learning principles and health behaviour change principles to reinforce and personalise the contents of the education for the participant. The time estimated for all telephone calls is 45 minutes. the time for each telephone call and the total time for all telephone calls is determined by the educator when they speak with the participant according to the participants response to the educator and questions that the participant may have.
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Intervention code [1]
292232
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Prevention
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Intervention code [2]
292233
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Treatment: Other
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Intervention code [3]
292234
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Behaviour
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Comparator / control treatment
The control group will receive 3 x 15 minute sessions in the week prior to hospital discharge with a trained health professional person who will discuss positive ageing with participants in the control group, using a scripted program, but will not give any specific falls prevention information to the participant.
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Control group
Active
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Outcomes
Primary outcome [1]
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Rate of falls assessed with a diary provided to participants and monthly phone calls after discharge
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Assessment method [1]
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Timepoint [1]
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6 months after hospital discharge
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Secondary outcome [1]
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Proportion of patients who fall assessed with a diary provided to
participants and monthly phone calls after discharge
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Assessment method [1]
315637
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Timepoint [1]
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6 months after hospital discharge
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Secondary outcome [2]
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Rate of injurious falls assessed with a diary provided to participants and monthly phone calls after discharge. Injurious fall defined as any fall where participant reports that the fall resulted in a physical injury including bruising, laceration, dislocation, fracture, loss of consciousness or if the participant reported persistent pain.
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Assessment method [2]
315638
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Timepoint [2]
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6 months after hospital discharge
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Secondary outcome [3]
315639
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Functional ability of participants measured using activities of daily living (ADL) and instrumental activities of daily living (IADL) measured by surveying participants at baseline and at 6months after discharge using the Katz and Lawtons scales
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Assessment method [3]
315639
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Timepoint [3]
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6 months after hospital discharge
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Secondary outcome [4]
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health related quality of life measured using the AQoL -6D
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Assessment method [4]
315867
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Timepoint [4]
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6 months after hospital discharge
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Eligibility
Key inclusion criteria
Inpatient rehabilitation ward being discharged from hospital within one week of enrolment into study
Discharged to community dwelling setting
Able to provide written informed consent
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Minimum age
60
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Discharge is to hostel or nursing home
Any diagnosis of cognitive impairment or confusion
Under care of palliative or mental health medical officer
Hearing impairment that precludes receiving telephone call
Readmission to hospital within last 14 days
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Eligible patients approached and written consent sought. Participants are enrolled by the research assistant. They are randomly allocated to groups in a 1:1 ratio in consecutive order after they are enrolled. The allocation is performed by the educator who phones the research officer of the co-investigator at an external university who is off site and not involved in recruitment, data collection or providing interventions. The officer at the co-investigator's university opens an opaque sealed envelope with the participant’s study identification number on it. The paper inside the envelope contains the group allocation.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The group allocation is determined by a computer generated random number sequence that is produced by a project collaborator at an external university who is not involved in recruitment, intervention or data collection. The external university prepares the envelopes.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Data will be analysed using an intention to treat analysis for all primary analyses using an alpha level set at 0.05. The primary outcome measure (rates of falls) will be analysed using negative binomial regression with adjustment for participant’s length of observation in the study. Secondary outcomes of functional ability (ADL and IADL) and HRQoL and will be compared between groups using linear regression with adjustment for levels of participation measured at baseline in hospital.The proportion of people who become fallers during the observation period will be analyzed using logistic regression with adjustment for length of observation in the study. Rates of injurious falls will also be analyzed using negative binomial regression with adjustment for participants’ length of observation in the study. Primary analyses will include pre-planned adjustment for baseline levels of covariates (history of falls during hospital admission or in 6 months prior to hospital admission, receiving assistance with ADL (as a dichotomous outcome), presence of depressed mood as measured by GDS and use of walking aid).
Total sample size is N=390 (allows for drop out of approximately 5%). Power calculation based upon detecting a 30% relative reduction in the rate of falls (negative binomial incidence rate ratio =0.70) from a control rate of 0.80 falls per person over the 6 month follow-up. Using these data with a two-tailed alpha =0.05, power =0.80, and a 1:1 control to intervention allocation ratio in the "Poisson regression" procedure from G*Power 3.14 determines that a total sample size of N=372 was required.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
29/07/2015
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Actual
4/08/2015
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Date of last participant enrolment
Anticipated
26/09/2016
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Actual
30/09/2017
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Date of last data collection
Anticipated
1/10/2018
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Actual
30/05/2018
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Sample size
Target
390
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Accrual to date
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Final
390
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment hospital [1]
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Bentley Health Service - Bentley
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Recruitment hospital [2]
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Armadale Kelmscott Memorial Hospital - Armadale
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Recruitment hospital [3]
3998
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Swan Districts Hospital - Middle Swan
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Recruitment postcode(s) [1]
9916
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6001 - Perth
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Recruitment postcode(s) [2]
9900
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6053 - Bayswater
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Recruitment postcode(s) [3]
9902
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6054 - Ashfield
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Recruitment postcode(s) [4]
9903
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6054 - Eden Hill
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Recruitment postcode(s) [5]
9904
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6056 - Midland
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Recruitment postcode(s) [6]
9905
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6058 - Forrestfield
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Recruitment postcode(s) [7]
9906
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6070 - Darlington
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Recruitment postcode(s) [8]
9909
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6101 - East Victoria Park
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Recruitment postcode(s) [9]
9907
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6102 - Bentley
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Recruitment postcode(s) [10]
9908
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6104 - Redcliffe
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Recruitment postcode(s) [11]
9910
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6107 - Queens Park
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Recruitment postcode(s) [12]
9911
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6110 - Gosnells
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Recruitment postcode(s) [13]
9915
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6110 - Southern River
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Recruitment postcode(s) [14]
9914
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6111 - Karragullen
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Recruitment postcode(s) [15]
9912
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6111 - Kelmscott
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Recruitment postcode(s) [16]
9913
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6112 - Armadale
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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National Health and Medical Research Council (Australia)
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Address [1]
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National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
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Country [1]
291582
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Australia
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Primary sponsor type
University
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Name
The University of Notre Dame Australia
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Address
19 Mouat St, PO Box 1225
Fremantle WA 6959
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Country
Australia
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Secondary sponsor category [1]
290254
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University
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Name [1]
290254
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University of Western Australia
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Address [1]
290254
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35 Stirling Hwy, Crawley WA 6009
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Country [1]
290254
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Australia
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Secondary sponsor category [2]
290255
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University
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Name [2]
290255
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Monash
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Address [2]
290255
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Monash University
Victoria 3800
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Country [2]
290255
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Australia
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Secondary sponsor category [3]
290256
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University
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Name [3]
290256
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Queensland University of Technology
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Address [3]
290256
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2 George Street, Brisbane QLD 4000
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Country [3]
290256
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Australia
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Secondary sponsor category [4]
290257
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University
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Name [4]
290257
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La Trobe
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Address [4]
290257
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Plenty Road & Kingsbury Drive,
Melbourne VIC 3086
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Country [4]
290257
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Australia
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Secondary sponsor category [5]
290258
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Hospital
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Name [5]
290258
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Malcom Randall VA Medical Center
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Address [5]
290258
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1601 SW Archer Rd
Gainesville, FL 32601
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Country [5]
290258
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United States of America
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Other collaborator category [1]
278508
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Individual
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Name [1]
278508
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Professor Terry Haines
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Address [1]
278508
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Monash University / Monash Health
Allied Health Research Unit
Kingston Centre, Kingston Rd, Cheltenham VIC 3192
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Country [1]
278508
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Australia
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Other collaborator category [2]
278509
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Individual
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Name [2]
278509
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Prof.Christopher Etherton-Beer
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Address [2]
278509
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WA Centre for Health & Ageing
University of Western Australia
35 Stirling Highway (M577)
CRAWLEY WA 6009
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Country [2]
278509
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Australia
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Other collaborator category [3]
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Individual
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Name [3]
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Dr Steven McPhail
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Address [3]
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Queensland University of Technology
2 George Street, Brisbane QLD 4000
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Country [3]
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Australia
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Other collaborator category [4]
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Individual
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Name [4]
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Professor Meg Morris
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Address [4]
278511
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La Trobe University
College of Science, Health and Engineering,School of Allied Health
Plenty Road & Kingsbury Drive, Melbourne VIC 3086
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Country [4]
278511
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Australia
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Other collaborator category [5]
278512
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Individual
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Name [5]
278512
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Professor Leon Flicker
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Address [5]
278512
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Western Australian Centre for Health & Ageing
Centre for Medical Research
University of Western Australia
35 Stirling Highway (M577)
CRAWLEY WA 6009
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Country [5]
278512
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Australia
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Other collaborator category [6]
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Individual
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Name [6]
278513
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Dr Ronald Shorr
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Address [6]
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Director, GRECC (182)
Malcom Randall VA Medical Center
1601 SW Archer Rd
Gainesville, FLORIDA 32601
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Country [6]
278513
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United States of America
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Other collaborator category [7]
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Individual
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Name [7]
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Professor Max Bulsara
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Address [7]
278514
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Chair in Biostatistics
Institute for Health Research
The University of Notre Dame Australia
PO Box 1225
Fremantle WA 6959
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Country [7]
278514
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
293078
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The University of Notre Dame Australia HREC
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Ethics committee address [1]
293078
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Research Office 19 Mouat St Fremantle WA 6959
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Ethics committee country [1]
293078
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Australia
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Date submitted for ethics approval [1]
293078
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Approval date [1]
293078
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14/03/2013
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Ethics approval number [1]
293078
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013018F
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Ethics committee name [2]
293079
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Sir Charles Gairdner Group(SCGH) HREC
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Ethics committee address [2]
293079
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HREC Office Department of Research 2nd Floor A Block Sir Charles Gairdner Hospital Hospital Avenue NEDLANDS WA 6009
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Ethics committee country [2]
293079
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Australia
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Date submitted for ethics approval [2]
293079
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Approval date [2]
293079
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10/06/2015
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Ethics approval number [2]
293079
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2015_055
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Ethics committee name [3]
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Curtin University Human Research Ethics Committee (EC00422)
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Ethics committee address [3]
300701
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Kent Street Bentley WA 6102 GPO Box U1987 Perth WA 6845
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Ethics committee country [3]
300701
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Australia
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Date submitted for ethics approval [3]
300701
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30/11/2015
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Approval date [3]
300701
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21/01/2016
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Ethics approval number [3]
300701
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HR14/2016
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Summary
Brief summary
Falls are the leading cause of injury-related hospitalisation in older people in Australia. Older people are at increased risk of falls after hospital discharge and these falls can lead to injury and loss of independence and quality of life. However older people have been found to have low levels of knowledge about falls and may be reluctant to engage in falls prevention activities, such as exercise. The primary aim of this trial is to determine if providing tailored falls prevention education that includes the provision of multimedia materials as well as individual health professional consultations and reinforcement in hospital and after discharge reduces falls rates in older people after discharge from hospital. A randomised trial will compare outcomes between a group that receive the education in addition to usual care and a group that receive social visits in addition to usual care.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Anne-Marie Hill
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Address
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School of Physiotherapy and Exercise Science, Curtin University Kent St, Bentley WA Australia, 6102 GPO
BOX U1987, Perth WA 6845
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Country
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Australia
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Phone
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+61892664104
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Fax
58274
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Email
58274
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anne-marie.hill@curtin.edu.au
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Contact person for public queries
Name
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Anne-Marie Hill
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Address
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School of Physiotherapy and Exercise Science, Curtin University Kent St, Bentley WA Australia, 6102 GPO
BOX U1987, Perth WA 6845
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Country
58275
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Australia
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Phone
58275
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+61892664104
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Fax
58275
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Email
58275
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anne-marie.hill@curtin.edu.au
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Contact person for scientific queries
Name
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Anne-Marie Hill
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Address
58276
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School of Physiotherapy and Exercise Science, Curtin University Kent St, Bentley WA Australia, 6102 GPO
BOX U1987, Perth WA 6845
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Country
58276
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Australia
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Phone
58276
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+61892664104
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Fax
58276
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Email
58276
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anne-marie.hill@curtin.edu.au
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
Type
Is Peer Reviewed?
DOI
Citations or Other Details
Attachment
Study results article
Yes
Hill AM, McPhail SM, Haines TP, Morris ME, Etherto...
[
More Details
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368804-(Uploaded-20-10-2021-11-28-42)-Journal results publication.pdf
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