Comparing two identically protocolized, multicentre, randomized controlled trials on caregiver-mediated exercises poststroke: Any differences across countries?

BACKGROUND: The evidence for rehabilitation interventions poststroke lack sufficient robustness. However, variation in treatment effects across countries have been given little attention. OBJECTIVE: To compare two identically protocolized trials conducted in different western countries in order to identify factors that may have caused variation in secondary trial outcomes. METHODS: Comparative study based on individual patient data (N = 129) from two randomized controlled trials, conducted in hospitals and rehabilitation facilities in the Netherlands (N = 66) and Australia (N = 63). Patients with stroke and their caregivers were randomly allocated to an 8-week caregiver-mediated exercises intervention (N = 63; 31 Australian and 32 Dutch) or to a control group (N = 66; 32 Australian and 34 Dutch). Patient characteristics, compliance, usual care and process measures were compared across countries. We examined if study setting significantly moderated the trial outcomes: Hospital Anxiety and Depression Scale, Fatigue Severity Scale and General Self-Efficacy Scale, measured at 8- and 12 weeks follow-up. In addition, we explored if factors that were significantly different across countries caused variation in these trial outcomes. RESULTS: Most patients suffered an ischemic stroke, were in the subacute phase and participated with their partner. Dutch patients were younger (P = 0.005) and had a lower functional status (P = 0.001). Australian patients were recruited earlier poststroke (P<0.001), spent less time in exercise therapy (P<0.001) and had a shorter length of stay (P<0.001). The level of contamination was higher (P = 0.040) among Dutch controls. No effect modification was observed and trial outcomes did not change after controlling for cross-country differences. CONCLUSIONS: The present study highlighted important clinical differences across countries whilst using an identical study protocol. The observed differences could result in a different potential for recovery and variation in treatment effects across trials. We argue that we can proceed faster to evaluating interventions within international pragmatic trials.

Caregiver-mediated exercises with e-health support for early supported discharge after stroke (CARE4STROKE): A randomized controlled trial.

BACKGROUND AND PURPOSE: We designed an 8-week caregiver-mediated exercise program with e-health support after stroke (CARE4STROKE) in addition to usual care with the aim to improve functional outcome and to facilitate early supported discharge by increasing the intensity of task specific training. METHODS: An observer-blinded randomized controlled trial in which 66 stroke patient-caregiver couples were included during inpatient rehabilitation. Patients allocated to the CARE4STROKE program trained an additional amount of 150 minutes a week with a caregiver and were compared to a control group that received usual care alone. Primary outcomes: self-reported mobility domain of the Stroke Impact Scale 3.0 (SIS) and length of stay (LOS). Secondary outcomes: motor impairment, strength, walking ability, balance, mobility and (Extended) Activities of Daily Living of patients, caregiver strain of caregivers, and mood, self-efficacy, fatigue and quality of life of both patients and caregivers. Outcomes were assessed at baseline, 8 and 12 weeks after randomization. RESULTS: No significant between-group differences were found regarding SIS-mobility after 8 (ß 6.21, SD 5.16; P = 0.229) and 12 weeks (ß 0.14, SD 2.87; P = 0.961), and LOS (P = 0.818). Significant effects in favor of the intervention group were found for patient's anxiety (ß 2.01, SD 0.88; P = 0.023) and caregiver's depression (ß 2.33, SD 0.77; P = 0.003) post intervention. Decreased anxiety in patients remained significant at the 12-week follow-up (ß 1.01, SD 0.40; P = 0.009). CONCLUSIONS: This proof-of concept trial did not find significant effects on both primary outcomes mobility and LOS as well as the secondary functional outcomes. Treatment contrast in terms of total exercise time may have been insufficient to achieve these effects. However, caregiver-mediated exercises showed a favorable impact on secondary outcome measures of mood for both patient and caregiver. CLINICAL TRIAL REGISTRATION: NTR4300, URL- http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4300.

Effectiveness of the Restore4Stroke self-management intervention "Plan ahead!": A randomized controlled trial in stroke patients and partners.

OBJECTIVE: To investigate the effectiveness of a self-management intervention aimed at proactive coping for stroke patients and partners, compared with an education intervention. DESIGN: Multicentre randomized controlled trial. PARTICIPANTS: The study included 113 stroke patients (mean age 57.0 years (standard deviation (SD) 9.0), mean 18.8 months after stroke (SD 28.4)) and 57 partners (mean age 59.2 years (SD 8.3)). METHODS: Participants were randomized to a self-management intervention, or an education intervention, both 10 weeks' duration, outpatient, stroke-specific, and group-based. Main patient inclusion criteria were symptomatic stroke (≥ 6 weeks previously) and reporting ≥ 2 restrictions on the Restriction subscale of the Utrecht Scale for Evaluation of Rehabilitation Participation. Measurements were performed immediately after intervention, and at 3 and 9 months follow-up. Primary patient and partner outcomes were proactive coping and participation restrictions. Analyses were based on linear mixed modelling. RESULTS: A significant effect was found only in partners' increased proactive coping at T2 (compared with education intervention). Beneficial trends were found for the self-manage-ment intervention in partners' self-efficacy and patients' health-related quality of life, mood complaints and participation restriction. CONCLUSION: Little convincing evidence was found favouring our self-management intervention over the education intervention; therefore, the self-management intervention should not be implemented yet in clinical practice. Further research is needed to explore beneficial trends.