Optimized Recruitment to Drive Equitable Research in Stroke, Empowering Decision-making (ORDERed)

NCT07576647 | Not Yet Recruiting

• 1 other identifier: ORDERed
• Study Type: interventional
• Target: 1,600
• Locations: 1 country
• Sites: 3

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Effectiveness - Enrollment rate

  Consented participants divided by total approached

  From initial contact with study coordinator to decision to participate (up to 30 days)

• Effectiveness - Efficiency

  Number of days and interactions between initial contact to decision to participate

  From initial contact with study coordinator to decision to participate (up to 30 days)

• Barriers and Facilitators

  All participants, whether or not they consent to the cohort study, will be invited to complete a brief 15-minute web-based survey regarding the recruitment process and their decision making regarding study participation, including reason(s) for participating or not participating.

  At time of enrollment decision to the StrokeGoRed study (consent or decline)

Secondary Outcomes (4)

• Feasibility - Reach

  At the end of the recruitment period

• Feasibility - Adoption

  At the end of the recruitment period

• Feasibility - Implementation

  At the end of the recruitment period

• Feasibility - Maintenance

  At the end of the recruitment period

Study Arms (2)

Traditional Recruitment Processes (TRADITIONAL)

OTHER

Traditional participant information letter and consent form only

Other: Traditional recruitment processes (TRADITIONAL)

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

EXPERIMENTAL

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

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

Interventions

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

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.

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

Traditional recruitment processes (TRADITIONAL) OTHER

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.

Traditional Recruitment Processes (TRADITIONAL)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Participants eligible for StrokeGoRed hospitalized cohort are eligible for ORDERed:
• Ischemic stroke
• Intracerebral hemorrhage
• 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

Sponsors & Collaborators

• McMaster University: lead

Study Sites (3)

Foothills Medical Centre

Calgary, Alberta, Canada

Location

Vancouver General Hospital

Vancouver, British Columbia, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Stroke; Ischemic Attack, Transient; Coitus

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia; 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

905-525-9140; atang@mcmaster.ca

Hanna Fang

CONTACT

905-525-9140; fangh@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Assistant Dean

Study Record Dates

• First Submitted: April 21, 2026
• First Posted: May 8, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): August 1, 2029
• Last Updated: May 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)