Background: The Trial of an Individualized Intervention for the Prevention of Stroke (TIIPS) study is evaluating the efficacy of Health Coaching and the Stroke Riskometer TM for secondary prevention after TIA/minor stroke. We aim to describe challenges to recruitment and how these were addressed.
Methods: The TIIPS RCT aims to 360 adults aged ≥18 years with recent TIA/minor stroke from public hospitals in New Zealand. Initially, the recruitment rate (10%) was lower than anticipated (20%), due to a large proportion of ineligible participants. Detailed documentation of reasons for exclusion informed strategies to improve recruitment; removing the upper age cut-off; relaxing the blood pressure (BP) and cognitive impairment cut-off; inclusion of recurrent stroke and heart attack; and increased timeframe of inclusion to 90 days post event. An additional recruitment site is planned in 2024.
Results: Since the relaxation of the inclusion criteria, the recruitment rate improved from 10% in December 2022 to 25% now. We recruited n= 57 people over 75 years, n=26 with systolic BP between 120 and 130 and on BP medication, n=53 with a lower cognitive impairment score, n=20 with recurrent stroke and heart attack. In total, 156 more people (65% of total randomised) met the criteria that would have been previously ineligible. None have reported difficulties with participation.
Discussion: Relaxation of the inclusion criteria has improved the recruitment rate of the trial. As an added benefit, the findings of the study are now applicable to a wider range of stroke patients for secondary prevention.