Trial Review

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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
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
Secondary ID [1] 286956 0
Nil known
Universal Trial Number (UTN)
U1111-1169-4492
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Accidental falls 295408 0
Functional ability 295409 0
Health related quality of life 295410 0
Condition category
Condition code
Injuries and Accidents 295665 295665 0 0
Other injuries and accidents
Physical Medicine / Rehabilitation 295666 295666 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 292232 0
Prevention
Intervention code [2] 292233 0
Treatment: Other
Intervention code [3] 292234 0
Behaviour
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.
Control group
Active

Outcomes
Primary outcome [1] 295465 0
Rate of falls assessed with a diary provided to participants and monthly phone calls after discharge
Timepoint [1] 295465 0
6 months after hospital discharge
Secondary outcome [1] 315637 0
Proportion of patients who fall assessed with a diary provided to
participants and monthly phone calls after discharge
Timepoint [1] 315637 0
6 months after hospital discharge
Secondary outcome [2] 315638 0
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.
Timepoint [2] 315638 0
6 months after hospital discharge
Secondary outcome [3] 315639 0
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
Timepoint [3] 315639 0
6 months after hospital discharge
Secondary outcome [4] 315867 0
health related quality of life measured using the AQoL -6D
Timepoint [4] 315867 0
6 months after hospital discharge

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
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

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)
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.
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.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
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.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
29/07/2015
Actual
4/08/2015
Date of last participant enrolment
Anticipated
26/09/2016
Actual
30/09/2017
Date of last data collection
Anticipated
1/10/2018
Actual
30/05/2018
Sample size
Target
390
Accrual to date
Final
390
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 3996 0
Bentley Health Service - Bentley
Recruitment hospital [2] 3997 0
Armadale Kelmscott Memorial Hospital - Armadale
Recruitment hospital [3] 3998 0
Swan Districts Hospital - Middle Swan
Recruitment postcode(s) [1] 9900 0
6053 - Bayswater
Recruitment postcode(s) [2] 9902 0
6054 - Ashfield
Recruitment postcode(s) [3] 9903 0
6054 - Eden Hill
Recruitment postcode(s) [4] 9904 0
6056 - Midland
Recruitment postcode(s) [5] 9905 0
6058 - Forrestfield
Recruitment postcode(s) [6] 9906 0
6070 - Darlington
Recruitment postcode(s) [7] 9907 0
6102 - Bentley
Recruitment postcode(s) [8] 9908 0
6104 - Redcliffe
Recruitment postcode(s) [9] 9909 0
6101 - East Victoria Park
Recruitment postcode(s) [10] 9910 0
6107 - Queens Park
Recruitment postcode(s) [11] 9911 0
6110 - Gosnells
Recruitment postcode(s) [12] 9912 0
6111 - Kelmscott
Recruitment postcode(s) [13] 9913 0
6112 - Armadale
Recruitment postcode(s) [14] 9914 0
6111 - Karragullen
Recruitment postcode(s) [15] 9915 0
6110 - Southern River
Recruitment postcode(s) [16] 9916 0
6001 - Perth

Funding & Sponsors
Funding source category [1] 291582 0
Government body
Name [1] 291582 0
National Health and Medical Research Council (Australia)
Country [1] 291582 0
Australia
Primary sponsor type
University
Name
The University of Notre Dame Australia
Address
19 Mouat St, PO Box 1225
Fremantle WA 6959
Country
Australia
Secondary sponsor category [1] 290254 0
University
Name [1] 290254 0
University of Western Australia
Address [1] 290254 0
35 Stirling Hwy, Crawley WA 6009
Country [1] 290254 0
Australia
Secondary sponsor category [2] 290255 0
University
Name [2] 290255 0
Monash
Address [2] 290255 0
Monash University
Victoria 3800
Country [2] 290255 0
Australia
Secondary sponsor category [3] 290256 0
University
Name [3] 290256 0
Queensland University of Technology
Address [3] 290256 0
2 George Street, Brisbane QLD 4000
Country [3] 290256 0
Australia
Secondary sponsor category [4] 290257 0
University
Name [4] 290257 0
La Trobe
Address [4] 290257 0
Plenty Road & Kingsbury Drive,
Melbourne VIC 3086
Country [4] 290257 0
Australia
Secondary sponsor category [5] 290258 0
Hospital
Name [5] 290258 0
Malcom Randall VA Medical Center
Address [5] 290258 0
1601 SW Archer Rd
Gainesville, FL 32601
Country [5] 290258 0
United States of America
Other collaborator category [1] 278508 0
Individual
Name [1] 278508 0
Professor Terry Haines
Address [1] 278508 0
Monash University / Monash Health
Allied Health Research Unit
Kingston Centre, Kingston Rd, Cheltenham VIC 3192
Country [1] 278508 0
Australia
Other collaborator category [2] 278509 0
Individual
Name [2] 278509 0
Prof.Christopher Etherton-Beer
Address [2] 278509 0
WA Centre for Health & Ageing
University of Western Australia
35 Stirling Highway (M577)
CRAWLEY WA 6009
Country [2] 278509 0
Australia
Other collaborator category [3] 278510 0
Individual
Name [3] 278510 0
Dr Steven McPhail
Address [3] 278510 0
Queensland University of Technology
2 George Street, Brisbane QLD 4000
Country [3] 278510 0
Australia
Other collaborator category [4] 278511 0
Individual
Name [4] 278511 0
Professor Meg Morris
Address [4] 278511 0
La Trobe University
College of Science, Health and Engineering,School of Allied Health
Plenty Road & Kingsbury Drive, Melbourne VIC 3086
Country [4] 278511 0
Australia
Other collaborator category [5] 278512 0
Individual
Name [5] 278512 0
Professor Leon Flicker
Address [5] 278512 0
Western Australian Centre for Health & Ageing
Centre for Medical Research
University of Western Australia
35 Stirling Highway (M577)
CRAWLEY WA 6009
Country [5] 278512 0
Australia
Other collaborator category [6] 278513 0
Individual
Name [6] 278513 0
Dr Ronald Shorr
Address [6] 278513 0
Director, GRECC (182)
Malcom Randall VA Medical Center
1601 SW Archer Rd
Gainesville, FLORIDA 32601
Country [6] 278513 0
United States of America
Other collaborator category [7] 278514 0
Individual
Name [7] 278514 0
Professor Max Bulsara
Address [7] 278514 0
Chair in Biostatistics
Institute for Health Research
The University of Notre Dame Australia
PO Box 1225
Fremantle WA 6959
Country [7] 278514 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293078 0
The University of Notre Dame Australia HREC
Ethics committee address [1] 293078 0
Ethics committee country [1] 293078 0
Australia
Date submitted for ethics approval [1] 293078 0
Approval date [1] 293078 0
14/03/2013
Ethics approval number [1] 293078 0
013018F
Ethics committee name [2] 293079 0
Sir Charles Gairdner Group(SCGH) HREC
Ethics committee address [2] 293079 0
Ethics committee country [2] 293079 0
Australia
Date submitted for ethics approval [2] 293079 0
Approval date [2] 293079 0
10/06/2015
Ethics approval number [2] 293079 0
2015_055
Ethics committee name [3] 300701 0
Curtin University Human Research Ethics Committee (EC00422)
Ethics committee address [3] 300701 0
Ethics committee country [3] 300701 0
Australia
Date submitted for ethics approval [3] 300701 0
30/11/2015
Approval date [3] 300701 0
21/01/2016
Ethics approval number [3] 300701 0
HR14/2016

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

Contacts
Principal investigator
Name 58274 0
A/Prof Anne-Marie Hill
Address 58274 0
School of Physiotherapy and Exercise Science, Curtin University Kent St, Bentley WA Australia, 6102 GPO
BOX U1987, Perth WA 6845
Country 58274 0
Australia
Phone 58274 0
+61892664104
Fax 58274 0
Email 58274 0
[email protected]
Contact person for public queries
Name 58275 0
Anne-Marie Hill
Address 58275 0
School of Physiotherapy and Exercise Science, Curtin University Kent St, Bentley WA Australia, 6102 GPO
BOX U1987, Perth WA 6845
Country 58275 0
Australia
Phone 58275 0
+61892664104
Fax 58275 0
Email 58275 0
[email protected]
Contact person for scientific queries
Name 58276 0
Anne-Marie Hill
Address 58276 0
School of Physiotherapy and Exercise Science, Curtin University Kent St, Bentley WA Australia, 6102 GPO
BOX U1987, Perth WA 6845
Country 58276 0
Australia
Phone 58276 0
+61892664104
Fax 58276 0
Email 58276 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
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Hill AM, McPhail SM, Haines TP, Morris ME, Etherto... [More Details] 368804-(Uploaded-20-10-2021-11-28-42)-Journal results publication.pdf

Documents added automatically
No additional documents have been identified.