Recruiting

ORDER Toolkit

Sponsor:

McMaster University

Code:

NCT07576647

Conditions

Stroke

Stroke (CVA) or Transient Ischemic Attack

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

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

Traditional recruitment processes (TRADITIONAL)

Study Details

Brief summary:

Stroke is a major health issue, especially for women, who are more likely than men to have worse outcomes and lower quality of life after a stroke. Yet, women are under-represented in stroke research, which limits how well treatments work for them. This study aims to change that by testing a new way to recruit women into stroke research using the ORDER toolkit, a set of easy-to-understand, women-focused materials like brochures and videos co-designed with patients. This new approach will be compared to the usual way of recruiting patients. The study will track how many people join, how long it takes to make a decision, and what influences participation. Patients and research coordinators will also share their feedback on the process. Our goal is to make stroke studies more inclusive so that research findings benefit everyone equally.

Conditions

Stroke

Stroke (CVA) or Transient Ischemic Attack

Study ID

NCT07576647

Start date

Aug 17, 2026

Status verified date

Oct, 2026

Completion date

Aug, 2029

Anticipated

Primary completion date

Aug, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Participants eligible for StrokeGoRed hospitalized cohort are eligible for ORDERed:

Inclusion Criteria:

  • All patients, regardless of age or baseline disability, seen in urgent TIA/stroke clinics and referred from the emergency department for suspected TIA or minor stroke will be included over one calendar year

Exclusion Criteria:

  • There are no exclusion criteria

Participants eligible for StrokeGoRed hospitalized cohort are eligible for ORDERed:

Inclusion Criteria:

  • Ischemic stroke
  • Intracerebral hemorrhage

Exclusion Criteria:

  • Cerebral venous thrombosis
  • Subarachnoid hemorrhage
  • Subdural hemorrhage
  • Intracranial hemorrhage due to trauma or underlying mass
  • Clinical transient ischemic attack without evidence of infarct on neuroimaging
  • Imaging abnormality (e.g., dissection, carotid stenosis, vessel irregularity) without imaging or clinical evidence of stroke
  • Stroke that occurred while being admitted for another reason
  • Stroke that started more than 14 days prior to admission
  • Stroke initially treated outside of Canada
  • Stroke where inpatient stroke or neurology service was not consulted

Study Design

Enrollment

1600 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

other: Traditional Recruitment Processes (TRADITIONAL)

Traditional participant information letter and consent form only

experimental: Supported, women-centred and aphasia-friendly recruitment process (ORDERed)

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

Interventions

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

In the ORDERed phase, the Site Coordinator will approach participants for interest in the cohort study by introducing the study and sharing a brochure and brief, women-centred, close-captioned video that further describes the study procedures. These recruitment materials were co-developed with patient partners with lived experience of stroke. The video and brochure will be available on a mobile tablet, with the brochure also available in hard copy. Materials include images representing diverse ethnocultural backgrounds and gender identities and feature the lead researcher and a patient partner. The Coordinator will watch the video with the potential participant, discuss the study, and answer questions. Participants may keep the tablet and printed materials to review and share with family, friends, or healthcare providers before making a decision about enrollment.

Traditional recruitment processes (TRADITIONAL)

With the traditional recruitment process (TRADITIONAL), participants are approached by the Site Coordinator for interest in the cohort study 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 to address any further questions and determine the decision whether to enroll in the study.

Primary outcome measure

  • Effectiveness - Enrollment rate [ Time Frame: From initial contact with study coordinator to decision to participate (up to 30 days) ]
  • Effectiveness - Efficiency [ Time Frame: From initial contact with study coordinator to decision to participate (up to 30 days) ]
  • Barriers and Facilitators [ Time Frame: At time of enrollment decision to the StrokeGoRed study (consent or decline) ]

Central Contacts and Locations

Central contacts

Ada Tang, PT PhD

905-525-9140atang@mcmaster.ca

Hanna Fang

905-525-9140fangh@mcmaster.ca

Locations

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Tatjana Sukovic

tatjana1.sukovic@sri.utoronto.ca

Principal Investigator:

Amy Yu, MD

More Information

Sponsor

McMaster University

Last update posted

Oct 9, 2026

Last verified

Oct, 2026

Keywords

  • Stroke rehabilitation
  • Clinical Trial
  • Informed consent
  • Diversity, Equity, Inclusion
  • Sex

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-10. This information was provided to ClinicalTrials.gov by McMaster University on 2026-10-09. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.