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Trial registered on ANZCTR
Registration number
ACTRN12623000915651
Ethics application status
Approved
Date submitted
2/08/2023
Date registered
25/08/2023
Date last updated
1/06/2024
Date data sharing statement initially provided
25/08/2023
Type of registration
Prospectively registered
Titles & IDs
Public title
Implementing an allied health reablement program in the community and in residential aged care:
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Scientific title
Implementing an allied health reablement program in the community and in residential aged care: investigating the impact on frailty.
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Secondary ID [1]
310035
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Nil
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Universal Trial Number (UTN)
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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:
Frailty
330578
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Falls
330579
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Condition category
Condition code
Physical Medicine / Rehabilitation
327415
327415
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0
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Physiotherapy
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Physical Medicine / Rehabilitation
327416
327416
0
0
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Occupational therapy
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Physical Medicine / Rehabilitation
327417
327417
0
0
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Speech therapy
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Physical Medicine / Rehabilitation
327762
327762
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0
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Other physical medicine / rehabilitation
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Public Health
327881
327881
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0
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Other public health
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The intervention will involve multiple allied health intervention with a client focussed approach. The client focussed approach means that the duration and dose will vary depending on the needs of the participant, guided by Discipline specific assessments. Participants could receive occupational therapy and/or physiotherapy and/or exercise physiology and/or speech pathology. A brief description of each Discipline's assessment and interventions are:
Occupational Therapy:
1. Assessments: Canadian Occupational Performance Measure.
2. Interventions: The COPM allows each participant to choose areas of everyday living that are important to them and they would like to perform better at. Some expected interventions for occupational therapy will include:
a. Self-care training: Some participants may have decreased ability to do activities of daily
living such as dressing or showering. The occupational therapist will address this.
b. Leisure: We expect many participants will have leisure interests that can't be met for a number of reasons (access, resources, transport) that could be addressed by an occupational therapist. If participants identify a leisure based goal through the COPM the occupational therapist and/or the allied health assistant will address this.
c. Productivity: Older people want to continue to be productive members of their community such as through volunteering and informal care of friends and family members.
3. Format and duration of intervention: We will offer each participant occupational therapy
for 1-2 hours, 3 times/per week for 6 weeks either individually or in groups. The maximum group size is 6 for occupational therapy.
Speech Pathology
In addition to the usual assessments and interventions dealing with swallowing, eating and
drinking, the Speech Pathologist will target communication and social engagement.
1. Assessment: RISE
2. Interventions: This will include changing the environment to promote communication
and use of alternative communication methods such as memory books and graphic cues. In
many cases, the Speech Pathologist will work with the Occupational Therapist in group or individual sessions.
3. Format and duration of intervention: We will offer each participant speech pathology for
1-2 hours, 2 times/per week for 6 weeks either individually or in groups. The maximum group size is 6 for speech pathology.
Physiotherapy and Exercise Physiology
A falls and balance intervention will target leg strength, standing balance exercises (reaching in standing, stepping)
Everyday living interventions include practice of everyday activities such as squats to reach downwards, stairs, negotiating obstacles and turning.
Format and Dose: Physiotherapy or exercise physiology sessions weekly for 6 weeks. Participants will receive a combination of 1-1 and group sessions based on their individual needs. 1-1 sessions will be twice weekly for 30 minutes.
Sessions to include exercises that are tailored to the resident’s mobility and physical ability.
Group intervention: Classes led by a physiotherapist or exercise physiologist and stratified by participants’ mobility level (grouping people of similar abilities wherever possible)
2 x 50 min classes per week for 6 weeks
Group size: 6-8 people per class
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Intervention code [1]
326456
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Treatment: Other
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Comparator / control treatment
No control group.
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Frailty.
Change in physical function as measured by the Short Physical Performance Battery
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Assessment method [1]
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Timepoint [1]
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Baseline and immediately after intervention ceases
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Primary outcome [2]
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Frailty
Change in frailty as measured by the Frailty NH Scale
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Assessment method [2]
335282
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Timepoint [2]
335282
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Baseline and immediately after intervention ceases
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Secondary outcome [1]
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Quality of Life
Measured by the QOL-ACC (Quality of Life Aged Care Consumers tool
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Assessment method [1]
423719
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Timepoint [1]
423719
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Baseline and immediately after intervention ceases
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Secondary outcome [2]
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Everyday function
Measured by the Canadian Occupational Performance Measure
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Assessment method [2]
423720
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Timepoint [2]
423720
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Baseline and immediately after intervention ceases
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Secondary outcome [3]
423721
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Communication and Engagement
Measured by the Revised Index for Social Engagement
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Assessment method [3]
423721
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Timepoint [3]
423721
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Baseline and immediately after intervention ceases
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Secondary outcome [4]
425354
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Participant experiences and opinions of the intervention will be determined by semi-structured, one-on-one face-to-face interview with a member of the research team.
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Assessment method [4]
425354
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Timepoint [4]
425354
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Immediately after the intervention ceases.
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Secondary outcome [5]
425355
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Family experiences and opinions of the intervention will be determined by semi-structured, one-on-one face-to-face interview with a member of the research team.
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Assessment method [5]
425355
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Timepoint [5]
425355
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Immediately after the intervention ceases.
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Secondary outcome [6]
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Staff experiences and opinions of the intervention will be determined by semi-structured, one-on-one face-to-face interview with a member of the research team.
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Assessment method [6]
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Timepoint [6]
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Immediately following the data collection for all resident participants (12 months).
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Eligibility
Key inclusion criteria
Any new or existing (permanent) resident (nursing home or independent living) of Estia Bexley and Estia Blakehurst is eligible.
Any relative, family member, Power or Attorney or Guardian of the resident is eligible for face to face interviews.
Any staff member involved in the care of the resident participant is eligible for face to face interviews.
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Minimum age
55
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?
Yes
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Key exclusion criteria
In some case people with severe cognitive impairment will not be able to engage in the allied health program. For example, people who have severe expressive and receptive communication impairment and who are immobile due to dementia are unlikely to be able to meaningfully engage in the program.
Anyone who is not a relative, family member, Power or Attorney or Guardian of the resident is not eligible for face to face interviews.
Staff members who have not been involved in the care of the resident participant are not eligible for face to face interviews.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
All outcome measures will be recorded on hard copy pre intervention and post intervention and transferred to SPSS. (IBM SPSS Statistics v27). Data will be presented descriptively (e.g age, sex, time in residence). Paired sample t tests will be used to calculate effect sizes for the primary outcome measures.
We will collect qualitative data from participants, their families and staff around their thoughts, experiences and opinions of the intervention. This will be collected in a semi-structured interview immediately after the intervention in the case of the participant and their family. In the case of staff, they will need to have been involved in the implementation of the intervention for at least 6 weeks to be interviewed. All interviews will be recorded, transcribed verbatim and analysed using Braun and Clarke’s Reflexive Thematic
Analysis approach (Braun and Clarke 2019).
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
2/10/2023
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Actual
10/05/2024
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Date of last participant enrolment
Anticipated
1/08/2024
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Actual
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Date of last data collection
Anticipated
28/10/2024
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Actual
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Sample size
Target
50
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Accrual to date
51
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment postcode(s) [1]
40738
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2221 - Blakehurst
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Recruitment postcode(s) [2]
40739
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2207 - Bexley
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Funding & Sponsors
Funding source category [1]
314214
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Other
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Name [1]
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Aged Care Research and Industry Innovation
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Address [1]
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Aged Care Research and Industry Innovation
c/o Flinders University
182 Victoria Square,
Adelaide, South Australia 5000
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Country [1]
314214
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Australia
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Primary sponsor type
University
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Name
University of Canberra
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Address
University Drive, Bruce, ACT, 2617
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Country
Australia
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Secondary sponsor category [1]
316146
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None
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Name [1]
316146
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Address [1]
316146
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Country [1]
316146
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Other collaborator category [1]
282741
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University
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Name [1]
282741
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Macquarie University
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Address [1]
282741
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Eastern Road
North Ryde NSW
2109
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Country [1]
282741
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Australia
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Other collaborator category [2]
282742
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Commercial sector/Industry
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Name [2]
282742
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Concentric Healthcare Services
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Address [2]
282742
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8/4 MacArthur Ave
Revesby NSW 2212
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Country [2]
282742
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Australia
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Other collaborator category [3]
282743
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Commercial sector/Industry
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Name [3]
282743
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Estia Health Residential Aged Care
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Address [3]
282743
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Estia Health
3-5 Eddystone Rd
Bexley NSW 2207
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Country [3]
282743
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
313338
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University of Canberra Human Research Ethics Commitee
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Ethics committee address [1]
313338
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11 Kirinari St, Bruce, ACT, 2617
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Ethics committee country [1]
313338
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Australia
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Date submitted for ethics approval [1]
313338
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01/06/2023
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Approval date [1]
313338
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06/07/2023
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Ethics approval number [1]
313338
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13306
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Summary
Brief summary
There is clear evidence from the recent Royal Commission in Aged Care Quality and Safety that (a) older people living in residential aged care and in the community need allied health services to optimise their health and well-being, (b) older people living in residential aged care and in the community are not getting the services they need, and (c) the ways in which allied health services are accessed in the aged care system is not working. The proposed intervention draws on a strong evidence base that reablement principles can improve outcomes for older people in living at home and in residential aged care. Reablement “involves time-limited interventions that are targeted towards a person’s specific goal or desired outcome to adapt to some functional loss or regain confidence and capacity to resume activities”. Some key points about programs that use reablement are they: • Focus on the skills, abilities and social situation a person has to help themselves, rather than doing things for the person; • Are focused, time-limited and goal focused; • Can focus on modifying tasks or the environment to address a loss of function and/or training a new skill and using existing social supports. There is evidence that allied health using reablement principles improve outcomes for older people including physical function, falls prevention, communication, nutrition, personal care and social function. However, the translation of this evidence into practice has not been systematically applied and reported in Australia. To address some of the issues around frailty, falls and social isolation identified in residential aged care and in the community, we will implement and evaluate a multidisciplinary allied health service consisting of physiotherapy, exercise physiology, occupational therapy and speech pathology. Importantly, this service will be based on evidence-based, reablement principles.
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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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Prof Stephen Isbel
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Address
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University of Canberra Hospital
20 Guraguma Street
Bruce ACT 2617
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Country
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Australia
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Phone
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+61 2 6207 5246
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Fax
127790
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Email
127790
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[email protected]
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Contact person for public queries
Name
127791
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Stephen Isbel
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Address
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University of Canberra Hospital
20 Guraguma Street
Bruce ACT 2617
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Country
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Australia
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Phone
127791
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+61 2 6207 5246
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Fax
127791
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Email
127791
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[email protected]
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Contact person for scientific queries
Name
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Stephen Isbel
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Address
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University of Canberra Hospital
20 Guraguma Street
Bruce ACT 2617
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Country
127792
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Australia
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Phone
127792
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+61 2 6207 5246
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Fax
127792
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Email
127792
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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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
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
19849
Ethical approval
386183-(Uploaded-01-08-2023-14-02-14)-Study-related document.pdf
19850
Informed consent form
386183-(Uploaded-01-08-2023-14-52-29)-Study-related document.doc
19856
Study protocol
386183-(Uploaded-02-08-2023-12-11-11)-Study-related document.docx
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.
Download to PDF