Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12623001013651
Ethics application status
Approved
Date submitted
8/08/2023
Date registered
19/09/2023
Date last updated
27/10/2024
Date data sharing statement initially provided
19/09/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Physical activity, goals and outcomes for older Australians in the Transition Care Program: a pragmatic randomised controlled trial
Scientific title
Using behavioural science to help older Australian in the Transition Care Program set community-based goals and optimise their physical activity: a randomised controlled trial
Secondary ID [1] 310320 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical inactivity 331043 0
Poor quality of life 331044 0
Condition category
Condition code
Physical Medicine / Rehabilitation 327838 327838 0 0
Other physical medicine / rehabilitation
Public Health 327839 327839 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Transition Care Program (TCP) case managers will deliver this intervention. Case managers are predominantly nursing or allied health professionals who take on additional responsibilities coordinating the care of older adults in the TCP. In TCP, usual care involves the coordination of slow-stream rehabilitation for older adults following a hospital stay. Rehabilitation services can include Physiotherapy, Occupational Therapy, Nursing, social care, support workers, and community transportation, tailored to the unique needs of each client. In the relevant sites, goal setting is part of standard care, although the type of goals is not pre-specified.

Case managers will guide clients in the intervention group to set and achieve community-based goals specifically, using a structured person-centred, motivation approach and behaviour change techniques. We hypothesise that participating in community-based activities, participants will increase their incidental and light-itensity activities. Case managers and other team members will be trained to use the Health Action Planning Approach (HAPA) method of behaviour change in conjunction with Social Cognitive Theory constructs of self-efficacy, social support, and outcome expectancies. Strategies will include education on perceived risks, outcome expectations, goal setting, self-monitoring, and motivational interviewing. Case managers will use these strategies each time they visit participants, usually once weekly for up to an hour, in-person in the clients’ home or via telephone. Family members can be present and involved as per usual practice. Most TCP clients stay in the program for 8 weeks, although up to 12 weeks is possible.
Participants will receive access to client materials to help them set and achieve their goals, mapped to the HAPA model. Resources available are both pre-existing (https://clinicalexcellence.qld.gov.au/sites/default/files/2019-04/goal-setting-workbook.pdf) and specifically designed for this study. Case managers will collect and record in electronic format information on client goals, including goal types, behaviour change strategies used, and whether goals are achieved.

Case managers and staff in TCP are allied health professionals with existing undergraduate or job-related training in goal setting. The upskilling training session with be delivered through a 90-minute face-to-face session on the theoretical background to behaviour change, as well as an applied portion with two case-studies. The session will be delivered at least one week prior to participant recruitment by members of the research team skills in behaviour change, goal setting, and geriatric medicine.
Intervention code [1] 326723 0
Behaviour
Intervention code [2] 326724 0
Lifestyle
Comparator / control treatment
Participants in the control group will receive usual care as described above, which involves no change to the goals that they set. This can include physiotherapy, occupational therapy, nursing, social care, support workers, and community transportation, tailored to the unique needs of each client. In the relevant sites, goal setting is part of standard care, although the type of goals is not pre-specified.
Control group
Active

Outcomes
Primary outcome [1] 335687 0
Daily step count, assessed with a Fitbit Inspire 2 activity monitor
Timepoint [1] 335687 0
At exit from TCP, usually 8 weeks post-enrolment
Primary outcome [2] 335688 0
Acceptability and Feasibility of the intervention, assessed with the Theoretical Framework of Acceptability questionnaire (composite score)
Timepoint [2] 335688 0
At TCP exit, usually after 8 weeks post-enrolment
Primary outcome [3] 335877 0
Acceptability and Feasibility of the intervention, assessed semi-structured interviews for participants, carers and staff
Timepoint [3] 335877 0
At TCP exit, usually after 8 weeks post-enrolment
Secondary outcome [1] 425179 0
Number of falls, self-reported by participants through personal recall
Timepoint [1] 425179 0
At TCP exit, usually after 8 weeks post-enrolment and again at 6 months post-enrolment
Secondary outcome [2] 425180 0
Quality of life, assessed using the SF-36 instrument
Timepoint [2] 425180 0
At TCP exit, usually after 8 weeks post-enrolment and again at 6 months post-enrolment
Secondary outcome [3] 425185 0
Physical function, assessed with the Short Physical Performance Battery
Timepoint [3] 425185 0
At TCP exit, usually after 8 weeks post-enrolment
Secondary outcome [4] 425186 0
Activities of daily living, assessed using the modified Barthel Index
Timepoint [4] 425186 0
At TCP exit, usually after 8 weeks post-enrolment
Secondary outcome [5] 425949 0
Length of stay (weeks, days) in the Transition Care Program, obtained through medical records
Timepoint [5] 425949 0
At TCP exit, up to 12 weeks post-enrolment
Secondary outcome [6] 425950 0
Number of hospital representations, obtained through medical records or self-report using personal recall
Timepoint [6] 425950 0
At TCP exit, usually 8 weeks post-enrolment, and again 6 months post-enrolment
Secondary outcome [7] 425951 0
Mortality, obtained through medical records
Timepoint [7] 425951 0
At TCP exit, usually 8 weeks post-enrolment
Secondary outcome [8] 425952 0
Discharge to a residential aged care facility, obtained through medical records
Timepoint [8] 425952 0
At TCP exit, usually 8 weeks post-enrolment
Secondary outcome [9] 425953 0
Number of TCP services used each week, obtained through medical records
Timepoint [9] 425953 0
At TCP exit, usually 8 weeks post-enrolment
Secondary outcome [10] 425954 0
Caregiver quality of life, assessed with the SF-35 instrument
Timepoint [10] 425954 0
At TCP exit, usually 8 weeks post-enrolment, and again 6 months post-enrolment
Secondary outcome [11] 425955 0
Caregiver burden, assessed with Caregiver Strain Index
Timepoint [11] 425955 0
At TCP exit, usually 8 weeks post-enrolment, and again 6 months post-enrolment
Secondary outcome [12] 426844 0
Type of TCP services used each week, obtained through medical records
Timepoint [12] 426844 0
At TCP exit, usually 8 weeks post-enrolment

Eligibility
Key inclusion criteria
For inclusion the potential participant will be:
• Enrolled in TCP
• Community-based clients
• Set only home-based goals
• Understand the research project and can sign the consent form
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The following will render a potential participant ineligible:
• Being wheelchair-bound
• Severe dementia or other cognitive impairment that prevents the client from participating in the study
• Have already set community-based goals
• Admitted to residential TCP

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)
A randomisation sequence will be generated by a statistician not involved in the project, and kept with the project manager, CI Reid. Once a participant has completed baseline assessments, CI Reid will assign them to either the intervention or control group, depending on the randomly generated sequence. CI Reid will not have contact with participants during the intervention period, and case managers will not be aware of the allocation sequence.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Approximately 160 TCP places are available within the recruitment area. Each TCP client stays within the program for up to 12 weeks; (average 8 weeks) therefore, over 6 months, we anticipate having access to 320 potential clients for recruitment. Of these, our previous data suggest that 35% will set home goals only, making them eligible for this study (n = 112). Assuming 80% of individuals are interested and agree to participate (the norm in studies with older adults) and 20% attrition through the study, we anticipate recruiting ~90 participants (n=45 in each group), with ~70 participants being able to be assessed at all time points.
Power calculation
Based on an increase of 3000 steps per day (equating to approximately 30 minutes of additional physical activity), and a standard deviation of 1460 from our previous data, a final sample size of 70 will provide >95% power to detect a statistically significant difference between the intervention and control groups.

This study has four objectives:
1) To understand the feasibility and acceptability of establishing community-based goals for older Australians in the TCP
Analysis: semi-structured interviews will be used and mapped to the RE-AIM framework and Consolidated Framework for Implementation Research

2) To examine if community-based goals result in higher amounts of incidental physical activity
Analysis: Differences in physical activity between the intervention and control group will be assessed using both multivariate linear regression (for continuous step counts) and logistic regression (to assess meeting physical activity guidelines vs not). Primary models of interest will follow intention-to-treat principles and be a-priori adjusted for age, sex, carer status, and MBI (assuming no issues with multicollinearity).

3) To conduct a randomised controlled trial of community versus home-based goals and their effect on client outcomes.
Analysis: Following intention-to-treat principles, multivariable linear mixed models will be used to examine the change in measured outcomes within and between the intervention and control groups.

4) To establish the minimum clinically meaningful increase in daily step count for TCP clients.
Analysis: . We will use a combination of anchor and distribution-based methods. For the anchor, both discharge to a residential aged facility (RACF) and re-admission to hospital (yes vs no) will be examined. A receiver operating characteristic (ROC) curve will be used to determine the MCID, that is, the daily step count increase that produces the greatest combined sensitivity and specificity (determined with the highest Youden’s index). In addition, the area under the ROC curve (AUROC) will be determined.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
2/10/2023
Actual
24/01/2024
Date of last participant enrolment
Anticipated
30/12/2025
Actual
Date of last data collection
Anticipated
30/12/2026
Actual
Sample size
Target
90
Accrual to date
4
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 314526 0
Hospital
Name [1] 314526 0
Metro South Health Research Support Scheme
Country [1] 314526 0
Australia
Primary sponsor type
Hospital
Name
Metro South Health Research Support Scheme
Address
199 Ipswich Rd, Woolloongabba QLD 4102
Country
Australia
Secondary sponsor category [1] 316475 0
None
Name [1] 316475 0
Address [1] 316475 0
Country [1] 316475 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313568 0
Metro South Health Human Research Ethics Committee
Ethics committee address [1] 313568 0
Ethics committee country [1] 313568 0
Australia
Date submitted for ethics approval [1] 313568 0
26/07/2023
Approval date [1] 313568 0
07/08/2023
Ethics approval number [1] 313568 0
HREC/2023/QMS/97661

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

Contacts
Principal investigator
Name 128578 0
Dr Salih Salih
Address 128578 0
Ground Floor, Building 7 (GARU)
Princess Alexandra Hospital, Ipswich Rd,
Woolloongabba QLD 4102
Country 128578 0
Australia
Phone 128578 0
+61 7 3176 7943
Fax 128578 0
Email 128578 0
[email protected]
Contact person for public queries
Name 128579 0
Natasha Reid
Address 128579 0
199 Ipswich Road
Princess Alexandra Hospital, Ipswich Rd,
Woolloongabba QLD 4102
Country 128579 0
Australia
Phone 128579 0
+61 411039969
Fax 128579 0
Email 128579 0
[email protected]
Contact person for scientific queries
Name 128580 0
Natasha Reid
Address 128580 0
199 Ipswich Road
Princess Alexandra Hospital, Ipswich Rd,
Woolloongabba QLD 4102
Country 128580 0
Australia
Phone 128580 0
+61 411039969
Fax 128580 0
Email 128580 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification.
When will data be available (start and end dates)?
Beginning 6 months following main results publication; no end date determined
Available to whom?
Case-by-case basis at the discretion of Primary Sponsor.
Available for what types of analyses?
To achieve the aims in the approved proposal.
For IPD meta-analyses
How or where can data be obtained?
Access is subject to approval by the Principle Investigator and can be requested by emailing [email protected] or [email protected].


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.