Trial of an Individualised Intervention for the Prevention of Stroke (TIIPS)- using health and wellness coaching

INTERVENTION: Health and wellness coaching (HWC) intervention: HWC is a multidimensional psychological behaviour change intervention aimed at improving self‐management of lifestyle behaviour and maintaining health and wellbeing. It fosters ongoing self‐directed learning, delivering a cost‐effective intervention in person or by telephone, and by medical or non‐medical personnel, thus saving cost and increasing the scope of implementation. Individuals who receive HWC have increased perceived health status, improved medication adherence, and physical activity, with significantly improved health outcomes shown in patients following myocardial infarction. There is no prescribed level of participation engagement (as the aim is to self‐empower the participant to make their own changes), but each session will allow the participant to set their own goals, which will be noted and discussed in the next session. Research staff will attend an intensive 4‐week coaching course, at Momentum Coaching (www.coachmomentum.co.nz), with two sessions in the first two weeks and 4 which includes training in core coaching competencies and code of ethics, developed by the International Coach Federation (ICF) to support greater understanding of the skills and approaches used in the coaching profession. The initial intervention will occur after the baseline assessment, to ensure the participant meets all the study criteria, and to collect all baseline health information. Following this, the participant will be randomised, and be informed of their group allocation to HWC. The designated coach (matched to the participant by the coach trainer, based on health and demographic information), will contact the participant to make an appointment to have the first session in person, (usually at the participa CONDITION: Neurological ‐ Other neurological disorders Stroke ‐ Haemorrhagic Stroke ‐ Ischaemic Stroke;transient ischaemic attack (TIA); ; Stroke ; transient ischaemic attack (TIA) PRIMARY OUTCOME: The primary end‐point is a change in systolic blood pressure from Baseline, with the study powered to detect a mean difference of 6 mm Hg (SD±20 mm Hg) between HWC and UC groups at 6 months post‐randomisation. Blood pressure will be measured using a sphygmomanometer. A total of three readings will be taken and the average of the last two will be used as the final value. [Assessments will take place at Baseline, then 3‐ monthly up to 12 months post‐randomisation ‐ the primary timepoint is at 6 months post‐randomisation. ] INCLUSION CRITERIA: 1. People aged between 18 years and 75 years diagnosed with TIA or first‐ever minor stroke (excluding SAH) (National Institutes of Health Stroke Scale (NIHSS) score less than or equal to 4) and/or modified Rankin Scale (mRS) score between 0‐2 at discharge in the past 6 weeks 2. Admitted to one of the three Auckland based hospitals or primary care for minor stroke or TIA 3. With at least 2 modifiable risk factors 4. Who can converse in English 5. Provides written informed consent SECONDARY OUTCOME: All cause mortality[12 months post randomisation] Blood cholesterol using blood test[6 months post randomisation] Blood glucose using blood test[6 months post randomisation] Blood pressure, using a sphygmomanometer[6‐months post‐randomisation] Change in the proportion of participants in ‘high’ and ‘intermediate’ to ‘low’ risk on the Life's Simple 7 (LS7) [6‐months post‐randomisation] Cognitive assessment score (Montreal Cognitive Assessment)[6‐months post randomisation] CVD adverse outcomes (fatal and nonfatal stroke, TIA, myocardial infarction and heart failure, death attributable to CVD) as a composite outcome. Outcomes will be assess by reviewing hospital clinical records [3, 6, 9 and 12 months post randomisation] Healthcare and community service costs assessed as self‐reported service use questionnaire at follow up.. [3, 6, 9, and 12 months post randomisation] Medication adherence (Self‐Efficacy For Appropriate Medication Use Scale (SEAMS)[3, 6, 9 and 12 months post randomisation] Productivity status will be self‐reported and will include items regarding status (e.g., paid work, voluntary work, homemaker, student, unemployed), hours (e.g., full/part time), compared to hospitalisation pre‐stroke status[3, 6, 9 and 12 months post randomisation] Quality of life (EQ5D) at 6‐months post‐randomisation[6 months post randomisation] Stroke awareness (using a stroke awareness questionnaire)[6‐ and 12‐months post randomisation] Stroke risk from Stroke Riskometer app – 5‐ year absolute risk[6‐ and 12‐months post‐randomisation] Stroke risk from Stroke Riskometer app – 5‐ year relative risk[12 months post randomisation]