Optimizing Recruitment to Drive Equitable Research Opportunity in Stroke Rehabilitation Trials in Canada

Summary

Stroke is a major health issue in Canada. Stroke affects over 400,000 Canadians, and this number is expected to nearly double by 2038. Research studies in stroke recovery can help us better understand effective rehabilitation treatments and help reduce the burden of stroke. Some groups of people however are commonly not included in stroke studies. For example, it is more common for men to take part in research than women, and people with aphasia (a language impairment commonly seen after stroke) are often excluded from studies. Also, deciding whether to even take part in a research study can be difficult and overwhelming, especially in the early days after stroke, leaving many people to decline to participate. Research has shown that women experience different barriers to participating in stroke research than men. This means that research findings, and the decisions made during stroke care based on these findings, may not reflect the true stroke population. Better ways to help support groups like women and people with aphasia to participate in stroke research are needed, so that study findings will better represent people living with stroke.

Conditions

• Stroke

Interventions

OTHER

Supported, women-centred and aphasia-friendly recruitment and enrollment process (ORDER)

Participants randomized into ORDER will be approached by the Site Coordinator for interest in the host trial. The Coordinator will introduce the trial and share a brief, women-centred, aphasia-friendly, close-captioned video that further describes the trial procedures and an accompanying leaflet. ORDER recruitment materials will be saved to a mobile tablet. The Coordinator will watch the video together with the potential participant, engage in discussion about the host trial and answer any questions they may have. The Coordinator will offer to leave the tablet with the potential participant, along with printed copies of the leaflet and participant information letter. The Coordinator will encourage them to share these materials with their family members, friends or member of their healthcare team who may assist with decision making. The Coordinator will return in the following days to address any further questions and determine the decision whether to enroll in the trial.

OTHER

Traditional recruitment and enrollment processes (TRAD)

Participants randomized into the traditional recruitment process (TRAD) will be approached by the Site Coordinator for interest in the CAMAROS trial and presented with the standard participant information letter and full informed consent form. The information letter and consent form will be left with the potential participant to view again; the Coordinator will encourage them to share these materials with their family members or friends who may assist with decision making. The Coordinator will return in the following days to address any further questions and determine the decision whether to enroll in the trial.

Sponsors & Collaborators

• McMaster University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-06-16

Primary Completion

2027-06-30

Completion

2027-06-30

Countries

• Canada

Study Locations