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

NCT06576089 | Recruiting

• 1 other identifier: ORDER-Pilot
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 5

Brief 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

Keywords

Stroke rehabilitation; Clinical trial; Informed consent; Diversity, Equity, Inclusion; Sex

Outcome Measures

Primary Outcomes (3)

• 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)

Study Arms (2)

Traditional recruitment and enrollment processes (TRAD)

OTHER

Traditional participant information letter and consent form only (TRAD)

Other: Traditional recruitment and enrollment processes (TRAD)

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

EXPERIMENTAL

Supplementing traditional recruitment methods (detailed participant information letter and consent form) with women-centred, aphasia-friendly recruitment video and leaflet (ORDER)

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

Interventions

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

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.

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

Traditional recruitment and enrollment processes (TRAD) OTHER

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.

Traditional recruitment and enrollment processes (TRAD)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary ischemic anterior circulation stroke
• Age ≥18 years
• ≥5 days but \<8 weeks after stroke on the date of medication (Maraviroc or placebo) start
• Hemiparesis requiring inpatient rehabilitation
• Assistance available for daily rehabilitation training practice and for transportation when needed
• Adequate language skills to understand Informed Consent and retain information during daily therapies
• At least one of the following: some shoulder abduction with gravity eliminated and visible extension in two or more digits OR visible hip flexion or extension

You may not qualify if:

• Pre-stroke modified Rankin score ≥2
• Limited resources or illness that will not enable a return to living outside of a facility
• History of dementia
• History of hepatitis or elevated hepatic transaminases or bilirubin
• History of renal insufficiency or creatinine clearance (eGFR) \<60mL / min / 1.73m2
• Cancer or other chronic illness that makes 1-year survival unlikely or will detract from the ability to carry out exercise and skills practice
• Existing pre-stroke serious disabling disease (e.g., Parkinson's disease, severe traumatic brain injury, amputation)
• Seizure related to stroke
• Acute or chronic epilepsy
• Currently taking any of the following anticonvulsant medications: Carbamazepine, Phenobarbital, Phenytoin
• Pregnant, breastfeeding, or positive test for pregnancy at baseline
• Women of childbearing potential who are not using one highly effective form of contraception or two forms of effective contraception
• Known HIV positivity
• Currently taking any of the following antifungal and/or antibacterial medications: Ketoconazole, Itraconazole, Voriconazole, Rifampin, Clarithromycin, Rifabutin + Protease Inhibitor
• Currently taking St. John's Wort

Sponsors & Collaborators

• McMaster University: lead

Study Sites (5)

University of Calgary & Foothills Medical Centre

Calgary, Alberta, T2N 2T9, Canada

RECRUITING

University of British Columbia & GF Strong Rehabilitation Centre

Vancouver, British Columbia, V5Z 2G9, Canada

RECRUITING

Dalhousie University

Halifax, Nova Scotia, B3H 3J5, Canada

RECRUITING

Parkwood Institute

London, Ontario, N6C 0A7, Canada

RECRUITING

Toronto Rehabilitation Institute - University Health Network

Toronto, Ontario, M5G 2A2, Canada

NOT YET RECRUITING

MeSH Terms

Conditions

Stroke; Coitus

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Sexual Behavior; Behavior

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Ada Tang, PT PhD

CONTACT

289-426-5768; atang@mcmaster.ca

Hanna Fang

CONTACT

289-426-0468; fangh@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Assistant Dean

Study Record Dates

• First Submitted: August 21, 2024
• First Posted: August 28, 2024
• Study Start: June 16, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: September 26, 2025

Record last verified: 2025-09

Locations

CA (5)