Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000311752
Ethics application status
Approved
Date submitted
27/01/2022
Date registered
18/02/2022
Date last updated
18/02/2022
Date data sharing statement initially provided
18/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The Taking Charge after Stroke Follow-up Study (TaCAS-FU): Longterm follow up of participants in the Taking Charge after Stroke (TaCAS) study
Scientific title
The Taking Charge after Stroke Follow-up Study (TaCAS-FU): Longterm follow up of participants in the Taking Charge after Stroke (TaCAS) study
Secondary ID [1] 306279 0
MRINZ Protocol TaCAS02
Universal Trial Number (UTN)
Trial acronym
TaCAS-FU
Linked study record
ACTRN12615001163594
Current study is a follow-up of participants who received an intervention/control in the parent study (ACTRN12615001163594)

Health condition
Health condition(s) or problem(s) studied:
Stroke 325036 0
Condition category
Condition code
Stroke 322469 322469 0 0
Haemorrhagic
Stroke 322470 322470 0 0
Ischaemic

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is a follow up study of a multicentre, randomised, controlled, parallel-group trial, with participants originally enrolled in seven New Zealand centres. Follow up will be blind to original treatment allocation. Participants in the original TaCAS study received one of three interventions, between two and 16 weeks following their stroke:

1) A single Take Charge session (TCS).
2) Two TCS; with the second six weeks after the first.
3) No TCS.

For participants in the single TCS group in the original TaCAS study:
This is a single 50-minute session (following a 30 minute baseline assessment) designed to engage the patient and their family in the process of recovery. This facilitates a process where patients identify for themselves areas where they could make progress and set personal goals i.e. self-directed rehabilitation (SDR). These are conducted either alone with the participant, or with a support person(s). There is no limit to the number of family/support people who can be involved. The baseline assessment of function and risk factors provides the context for the TCS. The TCS is identical to the TCS delivered in the Maori and Pacific Stroke Study (Harwood M, Weatherall M, Talemaitoga A, Barber PA, Gommans J, Taylor W, McPherson K, McNaughton H. Taking charge after stroke: promoting self-directed rehabilitation to improve quality of life - a randomized controlled trial. Clin Rehabil. 2012;26:493-501). Each session employs a structured format using the following main headings: Overall hopes, Main fears, My ‘Best Day’, Physical, Communication, Emotional/Mood, Information needs, Financial, Family, Secondary prevention. The process of describing goals under each heading is explained and where these are forthcoming they are written down. The person and family are encouraged to see this as an ongoing process where they can set new goals and modify existing goals at any time themselves. The person and family are encouraged to consider intermediate steps to the goal and how long it might take to achieve these. Finally they are encouraged to think about ways of making these intermediate steps happen. They are encouraged to ‘take charge’ of the process, having seen for themselves where the key issues are, and given basic skills and supports to write a self-directed rehabilitation plan for themselves (the person with stroke and their family). The intervention is delivered by a research assistant trained to be a facilitator of this process.

For participants in the two TCS group in the original TaCAS study:
The first session was identical to that of the single TCS group (including 30 minute baseline assessment). The second session was identical to the first session followed by a review of the goals and plan from the first session, and any additional goals. The same general headings were used to facilitate discussion. A reflective approach to problem-solving were maintained, including any difficulties achieving goals in the previous 6 weeks. As in the first session, family members/support people were encouraged to be involved. The duration of the second session was approximately 50 minutes.

The current study will include all surviving members of the previous study (4-5 years after their initial stroke) who consent to the follow-up. Participants will be screened for survival using medical records and then contacted by mail seeking consent to acquire health outcome information for a small subset of the original outcome measures (physical health, subsequent strokes, independence, living situation). These will be collected on paper (return mail), or by telephone (verbal consent) if there is no response to the mailout or if requested by the participant. Completion of all questionnaires is not expected to take more than 20 minutes for each participant, once completed their participation in the study is finished.
Intervention code [1] 322708 0
Not applicable
Comparator / control treatment
The control group received the same baseline assessment of function and risk factors as the intervention groups and then received written educational information about stroke prevention and management of common problems following stroke from the Stroke Foundation of New Zealand (total length of visit approximately 40 minutes).
Control group
Active

Outcomes
Primary outcome [1] 330250 0
Physical functioning assessed by the Physical Component Summary (PCS) of the Short Form 36 (SF-36) adapted to New Zealand norms.
Timepoint [1] 330250 0
Assessed 4-5 years after the initial stroke.
Secondary outcome [1] 405470 0
Participation in advanced activities of daily living assessed by the Frenchay Activities Index
Timepoint [1] 405470 0
Assessed 4-5 years after the initial stroke.
Secondary outcome [2] 405471 0
Dependancy assessed by the Modified Rankin Score
Timepoint [2] 405471 0
Assessed 4-5 years after the initial stroke
Secondary outcome [3] 405472 0
Survival assessed using data from medical records
Timepoint [3] 405472 0
Assessed 4-5 years after the initial stroke.
Secondary outcome [4] 405473 0
Any hospitalisation with new stroke (self reported in mail questionnaires or verbally via phone call).
Timepoint [4] 405473 0
Assessed 4-5 years after the initial stroke.

Eligibility
Key inclusion criteria
Any surviving participant of the original TaCAS study
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants who return the consent form answering 'I do not wish to participate' or those who otherwise indicate this to be the case.

Study design
Purpose
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
This is a cross-sectional observational follow up study of a previously selected cohort - participants randomised in 2016-2017 in the TaCAS trial. In that study 400 participants were randomised, 2 withdrew, 10 died by 12 months and all the remaining 388 participants were followed up at the 12 month (final) outcome assessment. Assuming a yearly mortality after stroke of 3%/year for the relatively mild severity of stroke in this study, we estimate approximately 330 participants to still be alive. If a further 10% are lost to follow up, 300 participants would give us 80% power to find a difference of 3.5 points in the primary outcome measure (the Physical Component Summary of the Short Form 36).

The primary analysis of the primary outcome variable, the Physical Component Summary (PCS) of the Short Form 36, will be ANCOVA; with PCS as a continuous co-variate and randomised treatment as the main predictor of interest. The number of TCS sessions will be used in a sensitivity analysis to explore a dose-response relationship with outcome. For the modified Rankin Scale we will use ordinal regression. Categorical variables will be analysed by logistic regression. Time to death will use survival analyses illustrated by Kaplan-Meier plots and analysed by Cox Proportional Hazards regression with randomised treatment as the main predictor.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2022
Actual
Date of last participant enrolment
Anticipated
1/05/2022
Actual
Date of last data collection
Anticipated
1/05/2022
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment outside Australia
Country [1] 24527 0
New Zealand
State/province [1] 24527 0
Auckland DHB, Counties-Manukau DHB, Hawkes Bay DHB, Capital and Coast DHB, Hutt Valley DHB, Mid-Central DHB, Canterbury DHB

Funding & Sponsors
Funding source category [1] 310627 0
Other Collaborative groups
Name [1] 310627 0
Medical Research institute of New Zealand
Country [1] 310627 0
New Zealand
Primary sponsor type
Individual
Name
Dr Harry McNaughton
Address
Medical Research Institute of New Zealand
Private Bag 7902, Wellington 6021, New Zealand
Country
New Zealand
Secondary sponsor category [1] 311841 0
None
Name [1] 311841 0
Address [1] 311841 0
Country [1] 311841 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310230 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 310230 0
Ethics committee country [1] 310230 0
New Zealand
Date submitted for ethics approval [1] 310230 0
17/05/2021
Approval date [1] 310230 0
25/08/2021
Ethics approval number [1] 310230 0
21/NTB/128

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

Contacts
Principal investigator
Name 116930 0
Dr Vivian Fu
Address 116930 0
Medical Research Institute of New Zealand
Private Bag 7902, Wellington 6021, New Zealand
Country 116930 0
New Zealand
Phone 116930 0
+64211340433
Fax 116930 0
Email 116930 0
[email protected]
Contact person for public queries
Name 116931 0
Alex Semprini
Address 116931 0
Medical Research Institute of New Zealand
Private Bag 7902, Wellington 6021, New Zealand
Country 116931 0
New Zealand
Phone 116931 0
+64 4 805 0147
Fax 116931 0
Email 116931 0
[email protected]
Contact person for scientific queries
Name 116932 0
Alex Semprini
Address 116932 0
Medical Research Institute of New Zealand
Private Bag 7902, Wellington 6021, New Zealand
Country 116932 0
New Zealand
Phone 116932 0
+64 4 805 0147
Fax 116932 0
Email 116932 0
[email protected]

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?

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.