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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:
Scientific title
Implementing an allied health reablement program in the community and in residential aged care: investigating the impact on frailty.
Secondary ID [1] 310035 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Frailty 330578 0
Falls 330579 0
Condition category
Condition code
Physical Medicine / Rehabilitation 327415 327415 0 0
Physiotherapy
Physical Medicine / Rehabilitation 327416 327416 0 0
Occupational therapy
Physical Medicine / Rehabilitation 327417 327417 0 0
Speech therapy
Physical Medicine / Rehabilitation 327762 327762 0 0
Other physical medicine / rehabilitation
Public Health 327881 327881 0 0
Other public health

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 326456 0
Treatment: Other
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 335281 0
Frailty.
Change in physical function as measured by the Short Physical Performance Battery
Timepoint [1] 335281 0
Baseline and immediately after intervention ceases
Primary outcome [2] 335282 0
Frailty
Change in frailty as measured by the Frailty NH Scale
Timepoint [2] 335282 0
Baseline and immediately after intervention ceases
Secondary outcome [1] 423719 0
Quality of Life
Measured by the QOL-ACC (Quality of Life Aged Care Consumers tool
Timepoint [1] 423719 0
Baseline and immediately after intervention ceases
Secondary outcome [2] 423720 0
Everyday function
Measured by the Canadian Occupational Performance Measure
Timepoint [2] 423720 0
Baseline and immediately after intervention ceases
Secondary outcome [3] 423721 0
Communication and Engagement
Measured by the Revised Index for Social Engagement
Timepoint [3] 423721 0
Baseline and immediately after intervention ceases
Secondary outcome [4] 425354 0
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.
Timepoint [4] 425354 0
Immediately after the intervention ceases.
Secondary outcome [5] 425355 0
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.
Timepoint [5] 425355 0
Immediately after the intervention ceases.
Secondary outcome [6] 425356 0
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.
Timepoint [6] 425356 0
Immediately following the data collection for all resident participants (12 months).

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

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
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).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
2/10/2023
Actual
10/05/2024
Date of last participant enrolment
Anticipated
1/08/2024
Actual
Date of last data collection
Anticipated
28/10/2024
Actual
Sample size
Target
50
Accrual to date
51
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 40738 0
2221 - Blakehurst
Recruitment postcode(s) [2] 40739 0
2207 - Bexley

Funding & Sponsors
Funding source category [1] 314214 0
Other
Name [1] 314214 0
Aged Care Research and Industry Innovation
Country [1] 314214 0
Australia
Primary sponsor type
University
Name
University of Canberra
Address
University Drive, Bruce, ACT, 2617
Country
Australia
Secondary sponsor category [1] 316146 0
None
Name [1] 316146 0
Address [1] 316146 0
Country [1] 316146 0
Other collaborator category [1] 282741 0
University
Name [1] 282741 0
Macquarie University
Address [1] 282741 0
Eastern Road
North Ryde NSW
2109
Country [1] 282741 0
Australia
Other collaborator category [2] 282742 0
Commercial sector/Industry
Name [2] 282742 0
Concentric Healthcare Services
Address [2] 282742 0
8/4 MacArthur Ave
Revesby NSW 2212
Country [2] 282742 0
Australia
Other collaborator category [3] 282743 0
Commercial sector/Industry
Name [3] 282743 0
Estia Health Residential Aged Care
Address [3] 282743 0
Estia Health
3-5 Eddystone Rd
Bexley NSW 2207
Country [3] 282743 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313338 0
University of Canberra Human Research Ethics Commitee
Ethics committee address [1] 313338 0
Ethics committee country [1] 313338 0
Australia
Date submitted for ethics approval [1] 313338 0
01/06/2023
Approval date [1] 313338 0
06/07/2023
Ethics approval number [1] 313338 0
13306

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

Contacts
Principal investigator
Name 127790 0
Prof Stephen Isbel
Address 127790 0

University of Canberra Hospital
20 Guraguma Street
Bruce ACT 2617
Country 127790 0
Australia
Phone 127790 0
+61 2 6207 5246
Fax 127790 0
Email 127790 0
stephen.isbel@canberra.edu.au
Contact person for public queries
Name 127791 0
Stephen Isbel
Address 127791 0
University of Canberra Hospital
20 Guraguma Street
Bruce ACT 2617
Country 127791 0
Australia
Phone 127791 0
+61 2 6207 5246
Fax 127791 0
Email 127791 0
stephen.isbel@canberra.edu.au
Contact person for scientific queries
Name 127792 0
Stephen Isbel
Address 127792 0
University of Canberra Hospital
20 Guraguma Street
Bruce ACT 2617
Country 127792 0
Australia
Phone 127792 0
+61 2 6207 5246
Fax 127792 0
Email 127792 0
stephen.isbel@canberra.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19849Ethical approval    386183-(Uploaded-01-08-2023-14-02-14)-Study-related document.pdf
19850Informed consent form    386183-(Uploaded-01-08-2023-14-52-29)-Study-related document.doc
19856Study 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.