Optimizing Recruitment to Drive Equitable Research Opportunity in Stroke Rehabilitation Trials in Canada
NCT Number: NCT06576089
Acronym: ORDER-P
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Stroke
Interventions: OTHER: Supported, women-centred and aphasia-friendly recruitment and enrollment process (ORDER)|OTHER: Traditional recruitment and enrollment processes (TRAD)
Sponsor: McMaster University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: OTHER
Start Date: 2024-09-01
Completion Date: 2027-06-30
Locations: University of Calgary & Foothills Medical Centre, Calgary, Alberta, T2N 2T9, Canada|University of British Columbia & GF Strong Rehabilitation Centre, Vancouver, British Columbia, V5Z 2G9, Canada|Dalhousie University, Halifax, Nova Scotia, B3H 3J5, Canada|Parkwood Institute, London, Ontario, N6C 0A7, Canada|Toronto Rehabilitation Institute - University Health Network, Toronto, Ontario, M5G 2A2, 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.

Primary Outcome Measures: Feasibility, Each site will record # patients approached, # consented (by men and women), date of initial contact by the Site Coordinator, date of decision (consent or decline), and # interactions between the Site Coordinator and potential participants for ORDER and TRAD., From date identified as eligible for the host trial to date of decision (consent or decline)|Barriers and facilitators, Short survey and semi-structured interviews to examine the perceptions of the enrollment and consent process of individuals approached to participate in CAMAROS and Site Coordinators. Reason(s) for declining to participate and recruitment reach (# and characteristics of individuals approached for CAMAROS) will also be recorded., From date of decision (consent or decline) for host trial to date of survey or interview|Preliminary estimates of effect, Each site will record # patients approached, # consented (by men and women), date of initial contact by the Site Coordinator, date of decision (consent or decline), and # interactions between the Site Coordinator and potential participants for ORDER and TRAD., From date identified as eligible for the host trial to date of decision (consent or decline)