Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000967785
Ethics application status
Approved
Date submitted
5/07/2022
Date registered
8/07/2022
Date last updated
10/12/2023
Date data sharing statement initially provided
8/07/2022
Date results information initially provided
10/12/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Recovering my way: Stroke survivors from rural and remote Queensland using technology to exploit their recovery potential.
Scientific title
Recovering my way: Feasibility and acceptability of stroke survivors from rural and remote Queensland using technology to exploit their recovery potential.
Secondary ID [1] 307465 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 326857 0
Condition category
Condition code
Physical Medicine / Rehabilitation 324072 324072 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Stroke survivor participants will undertake the Living My Life Program, which is designed to support the participant to work towards their goals, using technology in a way that works for them, in their world. The participant works through 5-steps, guided by an allied health clinician, over a 3-month period.

The Program begins with an initial interview by the therapist to determine what matters to the participant, their goals (e.g., going to church) and the strengths they can draw on, and the limitations they need to accommodate, in their world. In the following session (step 2), the therapist and participant co-design a home program in the form of an action plan. The action plan is goal-directed, incorporating activities related to goal practice, part-practice (e.g., walking on different surfaces), and addressing underlying impairments (e.g., strength). In step 3, the participant tries out their plan in their home. In step 4, the participant continues working through their plan independently, interspersed with coaching sessions with the therapist. Coaching sessions begin weekly, reducing to no less than monthly, as the participant gains confidence with their program. In the final step, the participant and therapist review the participant's progress and plan for continuing to work towards their goals. The participant records their activities throughout the Program in an electronic multimedia journal and monitors their progress using patient-reported outcomes. The therapist documents the sessions using purposefully designed templates. The participant is expected to attend 9 sessions, each lasting 30 - 60 minutes, over the 3 months.

Digital health technologies are used by the participant to undertake their planned activities and communicate with the therapist. All sessions are conducted via online videoconferencing.
Intervention code [1] 323923 0
Lifestyle
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 331864 0
Feasibility will be assessed according to minimum success criteria for:
• Recruitment (Eligibility, Refusals)
• Retention
• Adherence
• Compliance
• Attendance
• Safety / Adverse events

Feasibility data will be collected from the following documents: recruitment log, participant journal, therapist journal, session records, and adverse events form.
Timepoint [1] 331864 0
Feasibility data will be collected throughout the 3 month period, and finalised at the end of the period.
Primary outcome [2] 331898 0
Composite outcome

Acceptability will be determined using a two-step process:
• Acceptability of Intervention Measure (AIM), administered by electronic survey
• Semi-structured, individual interview with participant (60 minutes, video recording)
Timepoint [2] 331898 0
The AIM survey will be administered during the final review session at the end of the 3 month period. The semi-structured interview will occur within 2 weeks of the review session.
Secondary outcome [1] 411415 0
Participant reported outcome: Patient Specific Functional Scale, using a visual analogue scale (0-10)
Timepoint [1] 411415 0
Baseline, weeks 4, 8 and 12

Eligibility
Key inclusion criteria
(1) a diagnosis of stroke more than 6 months ago;
(2) living at home;
(3) with or without an NDIS package;
(4) able to communicate (either verbally, written or with an augmented communication device), or have a significant other who is able to facilitate communication;
(5) able to communicate over videoconference;
(6) 18 years of age or over; and,
(7) able to provide informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Potential participants will be excluded if they are participating in a centre-based program at NWCR.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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)
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
Efficacy
Statistical methods / analysis
Up to 5 stroke survivor participants will be recruited to the study. The sample size is appropriate for case studies, to allow for rich description of each participant's program. Participants will be purposively sampled for personal, geographic and cultural diversity.

Feasibility will be determined according to the minimum success criteria, using descriptive statistics.

Acceptability will be determined across the group of participants, using the Acceptability of Intervention Measure and thematic analysis of the participants' interview transcripts.

For each participant, impact will be determined according to participant-reported outcomes. Raw scores at the beginning and end of the program, and the overall change in scores, will be reported.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
11/07/2022
Actual
15/07/2022
Date of last participant enrolment
Anticipated
31/03/2023
Actual
7/03/2023
Date of last data collection
Anticipated
30/06/2024
Actual
Sample size
Target
5
Accrual to date
Final
5
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 37934 0
4825 - Mount Isa

Funding & Sponsors
Funding source category [1] 311742 0
University
Name [1] 311742 0
James Cook University
Country [1] 311742 0
Australia
Primary sponsor type
University
Name
Murtupuni Centre for Rural and Remote Health - James Cook University
Address
PO Box 2572
Mount Isa Qld 4825
Country
Australia
Secondary sponsor category [1] 313202 0
None
Name [1] 313202 0
Address [1] 313202 0
Country [1] 313202 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311186 0
James Cook University Human Research Ethics Committee
Ethics committee address [1] 311186 0
JCU Connect Ethics Team
Room 310, Building 142
1 James Cook Drive
Townsville QLD 4811
Ethics committee country [1] 311186 0
Australia
Date submitted for ethics approval [1] 311186 0
09/11/2021
Approval date [1] 311186 0
14/12/2021
Ethics approval number [1] 311186 0
H8616

Summary
Brief summary
The aim of this study is to assess the feasibility and acceptability of the Living My Life Program for stroke survivors beyond 6 months post-stroke, living in rural and remote areas. The Living My Life Program is a digital health intervention, designed to support the participant to work towards their goals, using technology in a way that works for them, in their world. Case study design, informed by principles of co-design, will be used to trial the Program with stroke survivors living in rural and remote locations. Feasibility will be assessed according to pre-determined minimum success criteria. Acceptability will be explored through a brief survey and semi-structured interviews with stroke survivor participants. Learnings from the study will be used to refine the Living My Life Program for subsequent use.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 120254 0
Mrs Sarah Jackson
Address 120254 0
Murtupuni Centre for Rural and Remote Health
PO Box 2572
Mount Isa Qld 4825
Country 120254 0
Australia
Phone 120254 0
+61 7 4745 4500
Fax 120254 0
Email 120254 0
sarah.jackson3@my.jcu.edu.au
Contact person for public queries
Name 120255 0
Mrs Sarah Jackson
Address 120255 0
Murtupuni Centre for Rural and Remote Health
PO Box 2572
Mount Isa Qld 4825
Country 120255 0
Australia
Phone 120255 0
+61 7 4745 4500
Fax 120255 0
Email 120255 0
sarah.jackson3@my.jcu.edu.au
Contact person for scientific queries
Name 120256 0
Mrs Sarah Jackson
Address 120256 0
Murtupuni Centre for Rural and Remote Health
PO Box 2572
Mount Isa Qld 4825
Country 120256 0
Australia
Phone 120256 0
+61 7 4745 4500
Fax 120256 0
Email 120256 0
sarah.jackson3@my.jcu.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
Due to the nature of this research (i.e. small sample from a remote location), supporting data is not available.


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.