Trial Review

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
ACTRN12625000783426
Ethics application status
Approved
Date submitted
8/07/2025
Date registered
24/07/2025
Date last updated
24/07/2025
Date data sharing statement initially provided
24/07/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Implementing the Adherence Counselling (ACTnow) Toolkit in a stroke follow-up clinic: A pilot feasibility randomized controlled trial
Scientific title
Implementing the Adherence Counselling (ACTnow) Toolkit in a stroke follow-up clinic: A pilot feasibility randomized controlled trial
Secondary ID [1] 314858 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
stroke 338135 0
Condition category
Condition code
Cardiovascular 334419 334419 0 0
Other cardiovascular diseases
Neurological 334531 334531 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention group participants will work with the ACTnow facilitator and, using a theoretically informed behaviour change approach, will work through the ACTnow Toolkit https://blendcreative.wixsite.com/act-now-toolkit. The ACTnow Toolkit is designed to facilitate the development of individualized tailored exercise or other lifestyle programs, including resources for assessment of potential barriers to adherence and strategies for promoting adherence. The pathway through the toolkit will be individually determined based on several questionnaires, and resources utilized can include the Capability, Opportunity, Motivation-Behaviour (COM-B) model questionnaire, the Stage of Change questionnaire, Behaviour Change Strategy Table, Action Plan, and Full Behaviour Change Plan. At the completion of this initial session which will be conducted by a registered physiotherapist, the participant will have a comprehensive, tailored, specific plan for change, incorporating theory-informed strategies to address identified potential barriers. This will be a one-off session, and it is anticipated that this will take approximately 60 minutes. All documents used in the toolkit session will be saved and stored for each participant
Intervention code [1] 331461 0
Rehabilitation
Comparator / control treatment
Control group participants will work with the ACTnow facilitator to identify a specific goal, related to the identified area of change, which will be recorded in their diary. This group will have a conversation focused on the goal without discussion of specific behaviour change strategies. It is anticipated that this will take up to 30 minutes. Goals will related tot he relevant lifestyle factor for the participants, such as exercise, diet and cessation of smoking.
Control group
Active

Outcomes
Primary outcome [1] 342117 0
Self-efficacy
Timepoint [1] 342117 0
One month and three months following the initial 1:1 session
Secondary outcome [1] 449601 0
Adherence
Timepoint [1] 449601 0
3 months following the initial 1:1 session

Eligibility
Key inclusion criteria
Eligible participants will be aged 18 years and over, diagnosed with stroke (ischemic or haemorrhagic) over 6 months prior, and able to communicate at a level to consent and participate in the ‘health coaching’ process with the ACTnow facilitator. The inclusion of telehealth participants will ensure priority populations (rural and remote) are included in this study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to consent due to insufficient cognitive ability and/or communication to understand the study aims and information

<18 years old

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)
Allocation is not concealed
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
7/07/2025
Date of last participant enrolment
Anticipated
29/06/2026
Actual
Date of last data collection
Anticipated
29/09/2026
Actual
Sample size
Target
60
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 28194 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 44406 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 319416 0
Hospital
Name [1] 319416 0
Local Enquiry Grant, Flinders Medical Centre, Adelaide , South Australia
Country [1] 319416 0
Australia
Primary sponsor type
Government body
Name
Southern Adelaide Local Health Network
Address
Country
Australia
Secondary sponsor category [1] 321904 0
None
Name [1] 321904 0
Address [1] 321904 0
Country [1] 321904 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317987 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 317987 0
Ethics committee country [1] 317987 0
Australia
Date submitted for ethics approval [1] 317987 0
30/05/2025
Approval date [1] 317987 0
04/06/2025
Ethics approval number [1] 317987 0

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

Contacts
Principal investigator
Name 142790 0
Dr Tamina Levy
Address 142790 0
Flinders Medical Centre, Flinders Drive, Bedford Park, 5042, South Australia
Country 142790 0
Australia
Phone 142790 0
+61 409282210
Fax 142790 0
Email 142790 0
[email protected]
Contact person for public queries
Name 142791 0
Tamina Levy
Address 142791 0
Flinders Medical Centre, Flinders Drive, Bedford Park, 5042, South Australia
Country 142791 0
Australia
Phone 142791 0
+61 409282210
Fax 142791 0
Email 142791 0
[email protected]
Contact person for scientific queries
Name 142792 0
Tamina Levy
Address 142792 0
Flinders Medical Centre, Flinders Drive, Bedford Park, 5042, South Australia
Country 142792 0
Australia
Phone 142792 0
+61 409282210
Fax 142792 0
Email 142792 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.