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

Not Applicable

• Conditions: Stroke; transient ischaemic attack (TIA); Neurological - Other neurological disorders; Stroke - Ischaemic; Stroke - Haemorrhagic

• Registration Number: ACTRN12622000939796
• Lead Sponsor: Auckland University of Technology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-07-01
• Last Update Posted: 9 August 2022

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 360

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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. ]