None listed
Conditions
Brief summary
The Trial of an Individualised Intervention for the Prevention of Stroke (TIIPS) is a randomised controlled trial of 360 participants, to test the effectiveness of Health and Wellness Coaching in preventing a major stroke in people who have experienced a minor stroke or TIA. The participants will be recruited from Auckland based public hospitals, In this study, trained health coaches will support people to make lifestyle behaviour changes to improve their health, especially their brain health. Their role is to work with people at an increased risk of stroke, having targeted conversations, utilising appropriate tools, and asking questions to find health solutions that will work best for each individual. The aim of the study is to test whether health and wellness coaching improves risk factors of stroke based on lifestyle changes made by participants to receive health and wellness coaching. As high blood pressure is the most important risk factor for stroke, We hypothesise that HWC will result in a 6 mm Hg clinically significant difference in systolic BP (SBP) changes at 6 months from baseline, between the HWC and UC groups. We also hypothesise that other lifestyle related risk factors will improve in the group that receive HWC.
Interventions
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 participant's home). The first session is expected to last about 1 hour. After this, further appointments are made to have the remaining sessions by video call (Zoom, or other options that suit the participant). These sessions are expected to last about 30 minutes. The intervention will combine educational material and intensive HWC coaching. The educational material is existing evidence-based information (booklets) on healthy eating guidelines for the prevention of cardiovascular disease including stroke, from the NZ Heart Foundation, Life After Stroke, an information guide on how to manage after stroke, including secondary prevention, from the New Zealand Stroke Foundation, and information about the Stroke Riskometer App, a free app that informs people about their personal risk of stroke, risk factors and how to manage them, including using goal setting and reminders, how to recognise stroke, and what to do if someone is having a stroke. No new material will be produced by the study team. Participants allocated to the HWC group will have 12 individual coaching sessions over 6 months with trained HWC coaches, of which 4 sessions are carried out weekly, 6 sessions fortnightly and the remaining two sessions monthly. The initial two sessions and the final session will be conducted face-to-face and the remaining coaching sessions via telephone. Between the final coaching session and the 12-month assessment, HWC participants will receive a short monthly telephone call from their coach to encourage maintenance of behaviour change. Coaching sessions will take up to 1 hour initially, with later sessions lasting about 30 minutes. Interventional Group participants will be provided with tools to assist with behaviour changes. The details of each session will be recorded in the study database (REDCap), (Session number, date, coach name etc, plus whether or not the session took place, and if missed, reasons for this). Coaches will also complete a self-evaluation form after each session on REDCap to evaluate and reflect on how each session went. Participants will also be invited to reflect on the sessions in an open format, which will be recorded on teh REDCap database.
Sponsors
Study design
Eligibility
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
Exclusion criteria
1. History of major stroke or myocardial infarction (verified through Clinical Portal medical records) 2. Planned carotid endarterectomy 3. Life-threatening conditions with a life expectancy less than 5 years 4. Current (in the past year) significant clinical depression/anxiety (Hospital Anxiety and Depression questionnaire (HADS) greater than or equal to 11 in either or both the depression and anxiety domains) (either in clinical records or at screening) OR psychiatric conditions (based on medical records), 5. History (past year) of alcohol or drug/substance abuse 6. Dependent on others (living in a rest-home/care facility) 7. Significant cognitive impairment or pre-existing diagnosis of dementia e.g. ACE-R less than 82 (from clinical records), or at screening (MoCA (less than 26)) 6. Participation in another RCT