Background:
Cognitive impairment and mood disturbances are common after stroke and negatively impact quality of life and functional ability. However, these conditions frequently lead to exclusion from clinical trials. This study aimed to evaluate sociodemographic differences between participants eligible and ineligible for the Individualised Intervention for the Prevention of Stroke (TIIPS) randomised controlled trial (RCT), which assessed health coaching for secondary stroke prevention.
Methods:
Baseline cognition was measured using the Montreal Cognitive Assessment (MoCA), and mood disturbances using the Hospital Anxiety and Depression Scale (HADS). Participants with MoCA scores below 23 or HADS subscale scores above 11 (i.e., anxiety and/or depression) were excluded.
Results:
Among 408 stroke participants screened, 82 (20%) were ineligible 72 (18%) due to low MoCA and 10 (2%) due to elevated HADS scores. Of those with low MoCA, 49 (68%) low education, and 39 (54%) had low income. Males were disproportionately affected, comprising 64% of those with cognitive impairment and 60% of those with mood disturbances. Among the 326 eligible participants, 114 (35%) had low education and 153 (47%) low income. Employment rates were similar (39%) across eligible and ineligible groups; however, higher income was associated with higher mood scores, and 50% of those with elevated HADS were employed.
Discussion:
Eligibility criteria in this secondary stroke prevention trial excluded many participants due to cognitive and mood issues, disproportionately affecting disadvantaged individuals and males. These exclusions, although necessary, limit the external validity of trials. Innovative research strategies are needed to enhance equity and representation in stroke prevention.