Trial of an Individualised Intervention for the Prevention of Stroke

TIIPS

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Summary:

TIA and minor stroke are at high risk of secondary vascular events including major stroke, myocardial infarction, cognitive deficits and death, as high as 25% within 90 days. Evidence suggests modifying health behaviours prevention is feasible, improves health outcomes, reduces healthcare costs, risk of stroke by about 80%, and stroke incidence about 50%. Health behaviours, lifestyle interventions, can lead to reductions in CVD and stroke. Health and wellness coaching (HWC) is a multidimensional intervention improving lifestyle and maintaining health and wellbeing. The main aim is to determine the effectiveness of HWC in improving blood pressure at 6 months post-randomisation and secondary aimsare to determine the impact of HWC on overall cardiovascular disease risk based on the LS7, use of the Stroke Riskometer app; quality of life; stroke awareness; cognition; medication adherence, adverse cardiovascular events, health service use and costs. Detect at least a 6 mm Hg clinically significant difference in systolic BP changes at 6 months from baseline, between the HWC and UC groups. Following screening for eligibility, consenting and the baseline assessment, participants will be randomised to Usual Care for HWC groups. Assessments are conducted at 3-, 6-, 9- and 12- months post-randomisation. The trial will determine HWC will lead to clinically meaningful improvements in lifestyle behaviours and reduce the risk for secondary vascular events including major stroke.

Design: A prospective, phase III, open-label, single-blinded end-point randomised controlled trial of 360 participants

Study population:

The study aims to recruit 360 adults aged 18 years or older recently diagnosed with TIA or first-ever minor stroke (excluding subarachnoid haemorrhage (SAH)) with no or minor disabilities at discharge, and who are independent in activities of daily living. Eligible participants would be those:

  • admitted to one of the three Auckland-based hospitals or identified via primary care for minor stroke or TIA
  • have at least 2 modifiable risk factors (such as diabetes, high cholesterol, smoking, overweight)
  • with systolic blood pressure either between 120-129 mm Hg and on blood pressure medications OR systolic blood pressure ≥130 mm Hg
  • able to  converse in English and provide written informed consent.

Investigators:

  • Prof Valery Feigin - NISAN, AUT
  • Prof Rita Krishnamurthi - NISAN, AUT
  • Dr Irene Zeng - AUT
  • Prof Suzanne Barker-Collo - The University of Auckland
  • Prof Alan Barber - The University of Auckland
  • Dr Braden Te Ao - The University of Auckland
  • Dr Yogini Ratnasabapathy - Te Whatu Ora - health New Zealand, Waitemata

Timeline: 01 October 2022 - 30 September 2024

Funded by: Health Research Council of New Zealand

Budget: $450.000