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DEFINITIONS
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.
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Scientific title
Recovering my way: Feasibility and acceptability of stroke survivors from rural and remote Queensland using technology to exploit their recovery potential.
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Secondary ID [1]
307465
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Nil known
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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:
Stroke
326857
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Condition category
Condition code
Physical Medicine / Rehabilitation
324072
324072
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0
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Physiotherapy
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
323923
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Lifestyle
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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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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.
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Assessment method [1]
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Timepoint [1]
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Feasibility data will be collected throughout the 3 month period, and finalised at the end of the period.
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Primary outcome [2]
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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)
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Assessment method [2]
331898
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Timepoint [2]
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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.
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Secondary outcome [1]
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Participant reported outcome: Patient Specific Functional Scale, using a visual analogue scale (0-10)
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Assessment method [1]
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Timepoint [1]
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Baseline, weeks 4, 8 and 12
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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.
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Minimum age
18
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?
No
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Key exclusion criteria
Potential participants will be excluded if they are participating in a centre-based program at NWCR.
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Study design
Purpose of the study
Treatment
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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)
Allocation is not concealed.
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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
Efficacy
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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.
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Recruitment
Recruitment status
Active, not recruiting
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Date of first participant enrolment
Anticipated
11/07/2022
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Actual
15/07/2022
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Date of last participant enrolment
Anticipated
31/03/2023
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Actual
7/03/2023
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Date of last data collection
Anticipated
30/06/2024
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Actual
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Sample size
Target
5
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Accrual to date
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Final
5
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment postcode(s) [1]
37934
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4825 - Mount Isa
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Funding & Sponsors
Funding source category [1]
311742
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University
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Name [1]
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James Cook University
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Address [1]
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1 James Cook Drive
Townsville Qld 4811
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Country [1]
311742
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Australia
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Primary sponsor type
University
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Name
Murtupuni Centre for Rural and Remote Health - James Cook University
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Address
PO Box 2572
Mount Isa Qld 4825
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Country
Australia
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Secondary sponsor category [1]
313202
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None
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Name [1]
313202
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Address [1]
313202
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Country [1]
313202
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
311186
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James Cook University Human Research Ethics Committee
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Ethics committee address [1]
311186
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JCU Connect Ethics Team
Room 310, Building 142
1 James Cook Drive
Townsville QLD 4811
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Ethics committee country [1]
311186
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Australia
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Date submitted for ethics approval [1]
311186
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09/11/2021
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Approval date [1]
311186
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14/12/2021
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Ethics approval number [1]
311186
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H8616
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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.
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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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Mrs Sarah Jackson
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Address
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Murtupuni Centre for Rural and Remote Health
PO Box 2572
Mount Isa Qld 4825
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Country
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Australia
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Phone
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+61 7 4745 4500
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Mrs Sarah Jackson
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Address
120255
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Murtupuni Centre for Rural and Remote Health
PO Box 2572
Mount Isa Qld 4825
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Country
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Australia
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Phone
120255
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+61 7 4745 4500
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Fax
120255
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Email
120255
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[email protected]
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Contact person for scientific queries
Name
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Mrs Sarah Jackson
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Address
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Murtupuni Centre for Rural and Remote Health
PO Box 2572
Mount Isa Qld 4825
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Country
120256
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Australia
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Phone
120256
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+61 7 4745 4500
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Fax
120256
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Email
120256
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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
Due to the nature of this research (i.e. small sample from a remote location), supporting data is not available.
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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.
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