Background
Early pre-hospital initiation of blood pressure (BP) lowering could improve outcomes for patients with acute stroke, by reducing hematoma expansion in intracerebral hemorrhage (ICH), and time to reperfusion treatment and risk of intracranial hemorrhage in ischemic stroke (IS). We present the design of the fourth INTEnsive ambulance-delivered blood pressure Reduction in hyper-ACute stroke Trial (INTERACT4).
Methods
A multi-center, ambulance-delivered, prospective, randomized, open-label, blinded endpoint (PROBE) assessed trial of pre-hospital BP lowering in 3116 hypertensive patients with suspected acute stroke at 50+ sites in China. Patients are randomized through a mobile phone digital system to intensive BP lowering to a target systolic BP of < 140 mmHg within 30 min, or guideline-recommended BP management according to local protocols. After the collection of in-hospital clinical and management data and 7-day outcomes, trained blinded assessors conduct telephone or face-to-face assessments of physical function and health-related quality of life in participants at 90 days. The primary outcome is the physical function on the modified Rankin scale at 90 days, analyzed as an ordinal outcome with 7 categories. The sample size was estimated to provide 90% power (α = 0.05) to detect a 22% reduction in the odds of a worse functional outcome using ordinal logistic regression.
Discussion
INTERACT4 is a pragmatic clinical trial to provide reliable evidence on the effectiveness and safety of ambulance-delivered hyperacute BP lowering in patients with suspected acute stroke.
Trial registration
ClinicalTrials.gov NCT03790800. Registered on 2 January 2019; Chinese Trial Registry ChiCTR1900020534. Registered on 7 January 2019. All items can be found in this protocol paper.
Background: Aboriginal women are frequently called upon to support their families and other community members. At times, such supporting roles can be burdensome for these women. Many Aboriginal women live with chronic conditions. We explored the ways in which the women's caring roles impacted on how they maintained their own health. Methods: The aim of this manuscript is to explore the psychosocial factors associated with the management of health and chronic disease in Aboriginal women. An interpretive phenomenological approach was used for the analysis of 72 in-depth semi-structured interviews. These interviews were conducted in four community controlled Aboriginal health services, in urban, rural and remote settings, across two states and a territory in Australia. Results: Women living with chronic disease experience multiple challenges while caring for family, such as intergenerational trauma, mental health issues relating to addiction, domestic and family violence and incarceration. When these women become ill, they also have to take care of themselves. These women provided informal and unfunded care in response to a range of complex family and community problems. This continuous caring for family affected the women's ability to maintain their health and manage their own chronic conditions. Conclusion: The caring roles and responsibilities Aboriginal women have in their community impact on their health. Aboriginal women provide much needed refuge and support to family and the wider community. Underfunded and over-burdened formal support services are not meeting the needs of many Aboriginal women. Improved culturally secure resources and social services are required within communities to support Aboriginal women to successfully manage their own health.
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