The Taking Charge After Stroke (TaCAS) study protocol: a multicentre, investigator-blinded, randomised controlled trial comparing the effect of a single Take Charge session, two Take Charge sessions and control intervention on health-related quality of life 12 months after stroke for non-Māori, non-Pacific adult New Zealanders discharged to community living

Fu, Vivian; Weatherall, Mark; McNaughton, Harry

doi:10.1136/bmjopen-2017-016512

Cited by 8 publications

(20 citation statements)

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“…The design, interventions, and main measures of the Taking Charge after Stroke trial have been reported previously. 1,21 This was a prospective, randomised, open trial of two active and one control intervention with blinded endpoint assessment in seven centres in New Zealand.…”

Section: Introductionmentioning

confidence: 99%

The effect of the Take Charge intervention on mood, motivation, activation and risk factor management: Analysis of secondary data from the Taking Charge after Stroke (TaCAS) trial

et al. 2021

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Objective: To use secondary data from the Taking Charge after Stroke study to explore mechanisms for the positive effect of the Take Charge intervention on physical health, advanced activities of daily living and independence for people after acute stroke. Design: An open, parallel-group, randomised trial with two active and one control intervention and blinded outcome assessment. Setting: Community. Participants: Adults ( n = 400) discharged to community, non-institutional living following acute stroke. Interventions: One, two, or zero sessions of the Take Charge intervention, a self-directed rehabilitation intervention which helps a person with stroke take charge of their own recovery. Measures: Twelve months after stroke: Mood (Patient Health Questionnaire-2, Mental Component Summary of the Short Form 36); ‘ability to Take Charge’ using a novel measure, the Autonomy-Mastery-Purpose-Connectedness (AMP-C) score; activation (Patient Activation Measure); body mass index (BMI), blood pressure (BP) and medication adherence (Medication Adherence Questionnaire). Results: Follow-up was near-complete (388/390 (99.5%)) of survivors at 12 months. Mean age (SD) was 72.0 (12.5) years. There were no significant differences in mood, activation, ‘ability to Take Charge’, medication adherence, BMI or BP by randomised group at 12 months. There was a significant positive association between baseline AMP-C scores and 12-month outcome for control participants (1.73 (95%CI 0.90 to 2.56)) but not for the Take Charge groups combined (0.34 (95%CI −0.17 to 0.85)). Conclusion: The mechanism by which Take Charge is effective remains uncertain. However, our findings support a hypothesis that baseline variability in motivation, mastery and connectedness may be modified by the Take Charge intervention.

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Section: Introductionmentioning

confidence: 99%

The effect of the Take Charge intervention on mood, motivation, activation and risk factor management: Analysis of secondary data from the Taking Charge after Stroke (TaCAS) trial

et al. 2021

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“…Participants were enrolled between October 2015 and August 2017. The full study protocol and results of the Taking Charge after Stroke trial, containing a full description of the study methods, are published elsewhere [4,6]. In brief, this was a prospective open-label randomised controlled trial comparing the Take Charge intervention to a control intervention with masked endpoint assessment.…”

Section: Methodsmentioning

confidence: 99%

“…The full study protocol and results of the Taking Charge after Stroke trial, containing a full description of the study methods, are published elsewhere. 4,6…”

Section: Methodsmentioning

confidence: 99%

Economic analysis of the ‘Take Charge’ intervention for people following stroke: Results from a randomised trial

Harwood

et al. 2021

Clin Rehabil

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Objective: To undertake an economic analysis of the Take Charge intervention as part of the Taking Charge after Stroke (TaCAS) study. Design: An open, parallel-group, randomised trial comparing active and control interventions with blinded outcome assessment Setting: Community. Participants: Adults ( n = 400) discharged to community, non-institutional living following acute stroke. Interventions: The Take Charge intervention, a strengths based, self-directed rehabilitation intervention, in two doses (one or two sessions), and a control intervention (no Take Charge sessions). Measures: The cost per quality-adjusted life year (QALY) saved for the period between randomisation (always post hospital discharge) and 12 months following acute stroke. QALYs were calculated from the EuroQol-5D-5L. Costs of stroke-related and non-health care were obtained by questionnaire, hospital records and the New Zealand Ministry of Health. Results: One-year post hospital discharge cost of care was mean (95% CI) $US4706 (3758–6014) for the Take Charge intervention group and $6118 (4350–8005) for control, mean (95% CI) difference $ −1412 (−3553 to +729). Health utility scores were mean (95% CI) 0.75 (0.73–0.77) for Take Charge and 0.71 (0.67–0.75) for control, mean (95% CI) difference 0.04 (0.0–0.08). Cost per QALY gained for the Take Charge intervention was $US −35,296 (=£ −25,524, € −30,019). Sensitivity analyses confirm Take Charge is cost-effective, even at a very low willingness-to-pay threshold. With a threshold of $US5000 per QALY, the probability that Take Charge is cost-effective is 99%. Conclusion: Take Charge is cost-effective and probably cost saving.

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“…Recruitment to the target of 400 participants was achieved close to schedule within 22 months. The trial was completed keeping to the original protocol which was published halfway through the trial (Fu et al, 2017).…”

Section: Discussionmentioning

confidence: 99%

“…A substantial part of this chapter has been previously published in BMJ Open as the TaCAS study protocol (Fu, Weatherall, & McNaughton, 2017). Acknowledgements are made to the other authors, Dr Harry McNaughton and Prof. Mark Weatherall, who provided feedback on the original manuscript.…”

Section: Methodsmentioning

confidence: 99%

Taking Charge After Stroke: A novel, community-based intervention to improve the lives of people with stroke

Fu¹

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<p>Background and aims: Stroke is the third leading cause of disability worldwide. Despite the recent development of hyper-acute therapies for stroke, outcomes for people with stroke and types of rehabilitation interventions have remained unchanged. Rehabilitation in New Zealand is largely therapy-based and uses goal setting as a main component, but evidence for effectiveness of these methods is weak. Attempts to enhance the effects of rehabilitation using a stroke liaison officer or a caregiver to lead rehabilitation at home have had no effect on outcomes. However, self-management interventions have shown some promise. The Take Charge session is a novel, community-based, self-management intervention, which was shown to significantly improve both independence and health-related quality of life at 12 months following stroke in Māori and Pacific New Zealanders. We formalised the components of the Take Charge session, based upon Self Determination Theory and qualitative research about the importance of Taking Charge in recovery. This allowed us to retest the intervention in a different population of people with stroke. We hypothesised that: (1) the beneficial effect of the Take Charge session would be reproducible in a larger cohort of non-Māori, non-Pacific people with stroke, and (2) that two Take Charge sessions would have a greater positive effect on health-related quality of life than one alone. Methods: We randomised 400 people within 16 weeks of acute stroke who had been discharged to community living at seven centres in New Zealand to either a single Take Charge session (TCS 1, n = 132), two Take Charge sessions (TCS 2, n = 138), or a control intervention (n = 130). The primary outcome was the Physical Component Summary score (PCS) of the Short Form 36 (SF-36) at 12 months following index stroke, comparing any Take Charge session exposure to control. Secondary outcomes included the PCS of the Short Form 12 (SF-12) at six months, participation measured by the Frenchay Activities Index at six and 12 months, and activities measured by the Barthel Index at six and 12 months. Outcome measures were performed by an assessor masked to allocation. Results: At 12 months following stroke, participants in either of the Take Charge groups (TCS 1 + TCS 2) scored 2.9 (95% CI 0.95 to 4.9, p = 0.004) points higher (better) than control on the SF-36 PCS. This difference was statistically and clinically significant. The effect size remained significant when we adjusted for pre-specified baseline variables, including age, gender, and baseline stroke severity. Furthermore, SF-12 PCS at six months showed improvement in similar direction and effect size, and improvement in participation was statistically significant at 12 months. There was a positive dose effect with each exposure to the Take Charge session predicting a 1.9 (95% CI 0.8 to 3.1, p < 0.001) point increase in the 12-month SF-36 PCS. Subsequently, we conducted an individual patient meta-analysis of the Take Charge session, pooling data with the initial Māori and Pacific Stroke Study. The pooled effect of any exposure to the Take Charge session was 3.74 (95% CI 1.96 to 5.51) points greater than control. Conclusion: The Take Charge session – a simple, self-management intervention, improved healthrelated quality of life and participation at 12 months. This thesis provides evidence for implementing such an intervention into routine, post-stroke care, to improve the quality of life of people with stroke in the long term.</p>

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Cited by 8 publications

References 18 publications

The effect of the Take Charge intervention on mood, motivation, activation and risk factor management: Analysis of secondary data from the Taking Charge after Stroke (TaCAS) trial

The effect of the Take Charge intervention on mood, motivation, activation and risk factor management: Analysis of secondary data from the Taking Charge after Stroke (TaCAS) trial

Economic analysis of the ‘Take Charge’ intervention for people following stroke: Results from a randomised trial

Taking Charge After Stroke: A novel, community-based intervention to improve the lives of people with stroke

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