Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001163594
Ethics application status
Approved
Date submitted
24/10/2015
Date registered
2/11/2015
Date last updated
24/11/2020
Date data sharing statement initially provided
24/11/2020
Date results provided
24/11/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Self-directed rehabilitation randomised controlled trial after stroke: a practical, low cost programme. The Taking Charge after Stroke (TaCAS) Study
Scientific title
For non-Maori, non-Pacific adult New Zealanders discharged to community living after stroke, does a single Take Charge session, or two Take Charge sessions, compared to a control intervention of educational stroke pamphlets, improve health related quality of life 12 months after the stroke?
Secondary ID [1] 287725 0
nil known
Secondary ID [2] 287726 0
MRINZ protocol TCS01
Universal Trial Number (UTN)
U1111-1171-4127
Trial acronym
TaCAS (Taking Charge After Stroke)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 296564 0
Condition category
Condition code
Stroke 296824 296824 0 0
Ischaemic
Stroke 296825 296825 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All non-Maori, non-Pacific acute stroke patients, likely to be discharged to non-institutional community living, admitted to any hospital in each of the seven DHBs will be approached by a clinician or stroke nurse with information regarding the study. With verbal agreement to participate, contact information will be sent to the researcher(s) responsible for local coordination of recruitment. Trained research assistants/researcher clinicians will contact the person by telephone (at least 3 days after the participant has been discharged home) and arrange a time for an initial visit.
The aim is that all initial visits should be conducted within 16 weeks of stroke onset (it is anticipated that in most instances this visit will occur between 3 and 12 weeks from stroke onset). Initial visits should not be conducted in the first week after the potential participant is discharged home or later than 18 weeks from the date of stroke onset.
At that visit, written informed consent will be obtained, and if the person is eligible they will be randomised by means of opening consecutively numbered sealed envelopes with random allocation generated from a random dataset by the study biostatistician. All subjects undergo baseline assessment which includes demographic details, pre-stroke dependency, activities of daily living (ADL) (Barthel Index (BI)), instrumental ADL (Frenchay Activities Index (FAI)), mRS, Short Form 12 version 2 Health Survey (SF-12v2), depression (Personal Health Questionnaire [PHQ-2]], Patient Activation Measure (PAM)], blood pressure, heart rate and rhythm, smoking, diabetes, weight, height, medications. Family members can be present, but do not participate in the baseline assessment. Thie assessment will take approximately 30 minutes. Participants will then receive one of:
Take charge session
This is an individual session with the person alone or with a support person(s). There is no limit to the number of family/support people who can be involved. This is a 50-minute session following a 30 minute baseline assessment designed to engage the patient and their family in the process of recovery, facilitating a process where they identify for themselves areas where they could make progress and set personal goals i.e. self-directed rehabilitation (SDR). 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).

A structured format uses 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 (total length of visit 80 minutes)

OR Two take charge sessions
For participants randomised to two TCS, the second session will be conducted six weeks after the first (if it is not possible to conduct the session 6 weeks after the first, it may be scheduled for up to but no later than 10 weeks after the first session). This is an individual session with the person alone or with a support person(s). A further structured risk factor and functional assessment will occur, 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 will be used to facilitate discussion. A reflective approach to problem-solving will be maintained, including any difficulties achieving goals in the previous 6 weeks. As in the first session, family members/support people are encouraged to be involved. The duration of the second session will be approximately 50 minutes.
OR Control
Monitoring adherence is straightforward: all participants randomised will attend the first session (as randomisation is part of the first session). Any participants randomised to 2 sessions but who are unable to complete the second session (eg through ill health or death) will be recorded as such. No participant has more than 2 sessions.
Intervention code [1] 293115 0
Rehabilitation
Intervention code [2] 293116 0
Behaviour
Intervention code [3] 293139 0
Treatment: Other
Comparator / control treatment
The control group will receive the same baseline assessment of function and risk factors as the intervention groups and will then receive 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] 296427 0
Physical functioning, assessed by the Physical Component Summary score of the Short Form 36 with two pre-specified comparisons, if there is overall evidence of a difference in mean values: Firstly all those randomised to Take Charge Sessions (TCS) compared to control and secondly TCS high dose (2 sessions) compared to TCS low dose (1 session)
Timepoint [1] 296427 0
12 months after stroke
Secondary outcome [1] 318416 0
PCS of the SF36, adjusted for the following baseline variable/s: Barthel Index Score three days after stroke, baseline PCS (using SF12), age, gender, living alone with the two pre-specified comparisons, if there is overall evidence of a difference in mean values: All TCS compared to control and secondly TCS high dose compared to TCS low dose. In this analysis the PCS will be treated as a continuous variable and then as an ordinal variable with up to 5 'bands' of PCS values.
Timepoint [1] 318416 0
12 months after stroke
Secondary outcome [2] 318417 0
Dependency mRS (0-5) treated as an ordinal scale variable
Timepoint [2] 318417 0
12 months after stroke
Secondary outcome [3] 318418 0
Dependency dichotomised as modified Rankin Score 0 to 2 compared to 3 to 5, for consistency with past literature
Timepoint [3] 318418 0
12 months after stroke
Secondary outcome [4] 318419 0
Death
Timepoint [4] 318419 0
12 months after stroke
Secondary outcome [5] 318420 0
Death or dependency (modified Rankin score 3-5)
Timepoint [5] 318420 0
12 months after stroke
Secondary outcome [6] 318421 0
Carer strain assessed by the Carer Strain Index
Timepoint [6] 318421 0
12 months after stroke
Secondary outcome [7] 318422 0
Quality of life assessed using the EuroQol visual analogue scale (VAS)
Timepoint [7] 318422 0
12 months after stroke
Secondary outcome [8] 318423 0
EuroQol health utility
Timepoint [8] 318423 0
12 months after stroke
Secondary outcome [9] 318424 0
Costs of rehabilitation assessed by review of local health authority records
Timepoint [9] 318424 0
from randomisation to 12 months after stroke
Secondary outcome [10] 318488 0
Costs of institutional care assessed by review of local health authority records
Timepoint [10] 318488 0
from randomisation to 12 months after stroke
Secondary outcome [11] 318489 0
Costs of rehospitalisation assessed by review of local health authority records
Timepoint [11] 318489 0
from randomisation up to 12 months after stroke
Secondary outcome [12] 318490 0
Costs of productivity losses for the participant and their primary carer(s) assessed by questionnaire.
Questionnaire designed specifically for this study
Timepoint [12] 318490 0
from randomisation up to 12 months after stroke
Secondary outcome [13] 351340 0
Frenchay Activities Index
Timepoint [13] 351340 0
12 months post stroke
Secondary outcome [14] 351341 0
Barthel Index
Timepoint [14] 351341 0
12 months post stroke
Secondary outcome [15] 351342 0
Patient Health Questionnaire (PHQ-2)
Timepoint [15] 351342 0
12 months post stroke
Secondary outcome [16] 351343 0
Autonomy-Mastery-Purpose-Connectedness (AMP-C) score
Timepoint [16] 351343 0
12 months post stroke
Secondary outcome [17] 351344 0
Recurrent stroke, assessed by hospital casenote review
Timepoint [17] 351344 0
12 months post stroke

Eligibility
Key inclusion criteria
- Non-Maori, non-Pacific adults >16 years of age with acute stroke
- Discharged from hospital to non-institutional community living situation
- Answering ‘No’ to the question ‘Are you fully recovered from your stroke?’ (i.e. modified Rankin Score (mRS) must be > 0)

There is no requirement that a family member or support person is present although this is encouraged. Family members/support people do not need to be normally resident with the participant.
Minimum age
17 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Inability to provide informed consent
- Unlikely to survive >12 months

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Computer-generated random allocation using consecutively numbered sealed envelopes for each study site
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-based randomisation program. Randomisation schedule created by study biostatistician and a member of the research office, not involved in the study will be responsible for creating the opaque sealed envelopes for each site.

Patients will be randomly assigned to one of three groups (1:1:1): a single Take Charge session, two Take Charge sessions or control
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Taking Charge after Stroke: statistical plan
Sample size calculation: In the Maori and Pacific Stroke Study (MaPSS) the root mean square error for PCS (the primary endpoint) was 10.8. The clinically significant difference for PCS has been estimated in non-stroke populations to be 5. Our analysis of PCS scores from the MaPPS study suggests a clinically significant difference is approximately 2.5. Thus a shift from 40 to 42.5, or 42.5 to 45 is a very meaningful clinical improvement for a person with stroke.
However, for the purposes of a study size calculation we have used a change of 5 in the PCS. This requires a total sample size of 360, 120 in each of three arms, and has 90% power to detect this difference. With provision for 10% drop out we plan to recruit 400 participants.

Each analysis is organised as: Comparison; Outcome variable; Time point after stroke; Analysis tool
Primary analysis
1.1 Take Charge vs control (2:1 participants); PCS of SF36 with the two pre-specified comparisons, if there is overall evidence of a difference in mean values:All TCS compared to control and secondly TCS high dose compared to TCS low dose ; 12 months; ANOVA

Secondary analyses
2.1 Take Charge vs control (2:1 participants); PCS of the SF36, adjusted for the following baseline variable/s: Barthel Index Score three days after stroke, baseline PCS (using SF12), age, gender, living alone with the two pre-specified comparisons, if there is overall evidence of a difference in mean values: All TCS compared to control and secondly TCS high dose compared to TCS low dose; 12 months; ANCOVA
2.10 Pre-specified subgroup analyses using an interaction term between randomised treatment and each of: Barthel Index at 3-5 days after stroke grouped severe (0-9), moderate (10-14) and mild (15-20), site ((a) all centres, (b) tertiary centres vs not), age (<75 years, 75+ years), gender, living alone, main support person (yes/no), type of stroke (ischaemic vs haemorrhage), received thrombolysis or thrombectomy (yes/no), taking fluoxetine at baseline (yes/no), significant communication disorder (vs none/mild), significant cognitive disorder (vs none/mild), Autonomy/Mastery/Purpose/Connectedness (AMP-C sum) questions, Patient Activation Measure;
12 months; ANCOVA
2.11 Take Charge vs control, treating PCS of the SF36 as an ordinal scale variable with up to 5 'bands' of scores, 12 months, ordinal logistic regression.
2.12 Take Charge vs control, treating PCS of the SF36 as a dichotomous variable, 12 months, logistic regression

2.2 Take Charge vs control Dependency mRS (0-5) treated as an ordinal scale variable;
12 months; Ordinal logistic regression

2.3 Take Charge vs control Dependency dichotomised as (mRS 0 to 2 compared to 3 to 5, for consistency with past literature. Note that if the proportional odds assumption is correct for 2.2 that this estimate will be the same; 12 months; Estimation of Relative Risk
2.4 Take Charge vs control; Death; 12 months; Estimation of Relative Risk
2.5 Take Charge vs control; Death or dependency based on mRS 0 to 2 compared to 3 to 5; 12 months; Estimation of Relative Risk
2.6 Take Charge vs control; Carer Strain Index treated as a continuous variable;
12 months; ANOVA
2.7 Take Charge vs control; EuroQol (Visual Analogue Scale) treated as a continuous variable; 12 months; ANOVA
2.8 Take Charge dose response; PCS of the SF36 treating the TCS dose (none, low dose, and high) as a continuous predictor; 12 months; ANCOVA
2.9 Take Charge vs control; Barthel Index as continuous variable; 12 months; ANOVA
2.10 Take Charge vs control; Frenchay Activities Index as continuous variable; 12 months; ANOVA
2.11 Take Charge vs control; Patient Health Questionnaire-2 as continuous variable; 12 months; ANOVA
2.12 Autonomy/Mastery/Purpose/Connectedness (AMP-C) score as continuous variable; 12 months; ANOVA
2.13 Take Charge vs control; contact with rehabilitation service (yes/no); 12 months; estimation of relative risk

2.14 Take Charge vs control; Each of the analyses described above; 6 months; As per 12month analysis
2.15 Take Charge vs control; Hospitalisations; 12 months; estimation of relative risk
2.16 Take Charge vs control; recurrent stroke; 12 months; estimation of relative risk
2.17 Take Charge vs control; Medication Adherence Questionnaire (MAQ) score as a dichotomised variable (0 vs 1-4); 12 months; estimation of relative risk

Meta-analysis 3.1
Take Charge vs control, combining individual patient data from Taking Charge after Stroke Study and Maori and Pacific Stroke Study; PCS; 12 months Linear Mixed Model
Meta-analysis 3.2 Take Charge vs control, combining individual patient data from Taking Charge after Stroke Study and Maori and Pacific Stroke Study; dependency (mRS 0-5) ordinal shift; 12 months; Generalised Linear Mixed Model

Economic analysis
4.1 Take Charge vs control; EuroQol health utility; 12 months; ANOVA
4.2 Take Charge vs control; Short Form 6D health utility; 12 months; ANOVA
4.3 Take Charge vs control; Dollars per QALY lost/saved; 12 months; Cost effectiveness analysis
4.4 Take Charge vs control; Multivariable; 12 months; Comprehensive cost consequence analysis (multiple costs, multiple outcome endpoints

5.0 Take Charge vs control; Multivariable; 12 months; Serious adverse events

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
9/11/2015
Actual
24/11/2015
Date of last participant enrolment
Anticipated
31/07/2017
Actual
22/08/2017
Date of last data collection
Anticipated
31/07/2018
Actual
31/07/2018
Sample size
Target
400
Accrual to date
Final
400
Recruitment outside Australia
Country [1] 7268 0
New Zealand
State/province [1] 7268 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] 292269 0
Government body
Name [1] 292269 0
Health Research Council of New Zealand
Country [1] 292269 0
New Zealand
Primary sponsor type
Other
Name
Medical Research Institute of New Zealand
Address
Medical Research Institute of New Zealand
Private Bag 7902
Wellington 6242
New Zealand
Country
New Zealand
Secondary sponsor category [1] 290948 0
None
Name [1] 290948 0
None
Address [1] 290948 0
None
Country [1] 290948 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293744 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 293744 0
Ethics committee country [1] 293744 0
New Zealand
Date submitted for ethics approval [1] 293744 0
11/08/2015
Approval date [1] 293744 0
01/09/2015
Ethics approval number [1] 293744 0
15/CEN/115

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 614 614 0 0
/AnzctrAttachments/369519-HDEC Letter 15CEN115 Approved FULL Application.pdf
Attachments [2] 615 615 0 0
/AnzctrAttachments/369519-HDEC Letter 15CEN115AM01 Approved Amendment.pdf

Contacts
Principal investigator
Name 61134 0
Dr Harry McNaughton
Address 61134 0
Programme Director, Stroke/Rehabilitation research
Medical Research Institute of NZ
Private Bag 7902
Wellington 6242
Country 61134 0
New Zealand
Phone 61134 0
+64 22 0194444
Fax 61134 0
+64 4 389 5707
Email 61134 0
[email protected]
Contact person for public queries
Name 61135 0
Harry McNaughton
Address 61135 0
Programme Director, Stroke/Rehabilitation research
Medical Research Institute of NZ
Private Bag 7902
Wellington 6242
Country 61135 0
New Zealand
Phone 61135 0
+64 22 0194444
Fax 61135 0
+64 4 389 5707
Email 61135 0
[email protected]
Contact person for scientific queries
Name 61136 0
Harry McNaughton
Address 61136 0
Programme Director, Stroke/Rehabilitation research
Medical Research Institute of NZ
Private Bag 7902
Wellington 6242
Country 61136 0
New Zealand
Phone 61136 0
+64 22 0194444
Fax 61136 0
+64 4 389 5707
Email 61136 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

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No additional documents have been identified.