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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.

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.

Background and Purpose: "Take Charge" is a novel, community-based self-directed rehabilitation intervention which helps a person with stroke take charge of their own recovery. In a previous randomized controlled trial, a single Take Charge session improved independence and health-related quality of life 12 months following stroke in Māori and Pacific New Zealanders. We tested the same intervention in three doses (zero, one, or two sessions) in a larger study and in a broader non-Māori and non-Pacific population with stroke. We aimed to confirm whether the Take Charge intervention improved quality of life at 12 months after stroke in a different population and whether two sessions were more effective than one., Methods: We randomized 400 people within 16 weeks of acute stroke who had been discharged to institution-free community living at seven centers in New Zealand to a single Take Charge session (TC1, n = 132), two Take Charge sessions six weeks apart (TC2, n = 138), or a control intervention (n = 130). Take Charge is a "talking therapy" that encourages a sense of purpose, autonomy, mastery, and connectedness with others. The primary outcome was the Physical Component Summary score of the Short Form 36 at 12 months following stroke comparing any Take Charge intervention to control., Results: Of the 400 people randomized (mean age 72.2 years, 58.5% male), 10 died and two withdrew from the study. The remaining 388 (97%) people were followed up at 12 months after stroke. Twelve months following stroke, participants in either of the TC groups (i.e. TC1 + TC2) scored 2.9 (95% confidence intervals (CI) 0.95 to 4.9, p = 0.004) points higher (better) than control on the Short Form 36 Physical Component Summary. This difference remained significant when adjusted for pre-specified baseline variables. There was a dose effect with Short Form 36 Physical Component Summary scores increasing by 1.9 points (95% CI 0.8 to 3.1, p < 0.001) for each extra Take Charge session received. Exposure to the Take Charge intervention was associated with reduced odds of being dependent (modified Rankin Scale 3 to 5) at 12 months (TC1 + TC2 12% versus control 19.5%, odds ratio 0.55, 95% CI 0.31 to 0.99, p = 0.045)., Conclusions: Confirming the previous randomized controlled trial outcome, Take Charge-a low-cost, person-centered, self-directed rehabilitation intervention after stroke-improved health-related quality of life and independence., Clinical Trial Registration-Url: http://www.anzctr.org.au. Unique identifier: ACTRN12615001163594.

Objective: Few community interventions following stroke enhance activity, participation or quality of life. We tested two novel community interventions designed to promote self-directed rehabilitation following stroke., Design: This was a randomized, controlled parallel group 2×2 trial., Setting: Community., Participants: Maori and Pacific New Zealanders, >15 years old, randomized within three months of a new stroke., Interventions: A DVD of four inspirational stories by Maori and Pacific people with stroke and a 'Take Charge Session'--a single structured risk factor and activities of daily living assessment, designed to facilitate self-directed rehabilitation., Main Measures: Primary outcomes were Health-related Quality of Life (Physical Component Summary (PCS) and Mental Component Summary (MCS) scores of the Short Form 36 (SF-36)) 12 months from randomization. Secondary outcomes were Barthel Index, Frenchay Activities Index, Carer Strain Index and modified Rankin score., Results: One hundred and seventy-two people were randomized with 139 (80.8%) followed up at 12 months post randomization. The effect of the Take Charge Session on SF-36 PCS at 12 months was 6.0 (95% confidence interval (CI) 2.0 to 10.0) and of the DVD was 0.9 (95% CI -3.1 to 4.9). Participants allocated to the Take Charge Session were less likely to have a modified Rankin score of >2 (odds ratio (OR) 0.42, 95% CI 0.2 to 0.89) and their carers had lower (better) Carer Strain Index scores (-1.5, 95% CI -2.8 to -0.1)., Conclusion: A simple, low-cost intervention in the community phase of stroke recovery aiming to promote self-directed rehabilitation improved outcomes.

Background: Epidemiological studies suggest that raised plasma concentrations of total homocysteine (tHcy) may be a common, causal and treatable risk factor for atherothromboembolic ischaemic stroke, dementia and depression. Although tHcy can be lowered effectively with small doses of folic acid, vitamin B(12) and vitamin B(6), it is not known whether lowering tHcy, by means of B vitamin therapy, can prevent stroke and other major atherothromboembolic vascular events., Aim: To determine whether the addition of B-vitamin supplements (folic acid 2 mg, B(6) 25 mg, B(12) 500 microg) to best medical and surgical management will reduce the combined incidence of stroke, myocardial infarction (MI) and vascular death in patients with recent stroke or transient ischaemic attack (TIA) of the brain or eye., Design: A prospective, international, multicentre, randomised, double blind, placebo-controlled clinical trial., Setting: One hundred and four medical centres in 20 countries on five continents., Subjects: Eight thousand (6600 recruited as of 5 January, 2006) patients with recent (<7 months) stroke (ischaemic or haemorrhagic) or TIA (brain or eye)., Randomisation: Randomisation and data collection are performed by means of a central telephone service or secure internet site., Intervention: One tablet daily of either placebo or B vitamins (folic acid 2 mg, B(6) 25 mg, B(12) 500 mug)., Primary Outcome: The composite of stroke, MI or death from any vascular cause, whichever occurs first. Outcome and serious adverse events are adjudicated blinded to treatment allocation., Secondary Outcomes: TIA, unstable angina, revascularisation procedures, dementia, depression. STATISTICAL POWER: With 8000 patients followed up for a median of 2 years and an annual incidence of the primary outcome of 8% among patients assigned placebo, the study will have at least 80% power to detect a relative reduction of 15% in the incidence of the primary outcome among patients assigned B vitamins (to 6.8%/year), applying a two-tailed level of significance of 5%., Conclusion: VITATOPS aims to recruit and follow-up 8000 patients between 1998 and 2008, and provide a reliable estimate of the safety and effectiveness of folic acid, vitamin B(12), and vitamin B(6) supplementation in reducing recurrent serious vascular events among a wide range of patients with TIA and stroke throughout the world.