ORDERed Recruitment for Stroke Research

(ORDERed Trial)

Not yet recruiting at 2 trial locations
AT
HF
Overseen ByHanna Fang
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: McMaster University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to recruit women into stroke research using user-friendly materials such as brochures and videos. The goal is to make stroke studies more inclusive by comparing this new recruitment method, called ORDERed, to the traditional one. Researchers will evaluate how many people join, how quickly they decide, and what influences their participation. Ideal candidates for the trial are patients with recent strokes or transient ischemic attacks (mini-strokes) referred from an emergency department. As an unphased trial, this study provides a unique opportunity to enhance recruitment methods and make stroke research more inclusive.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the ORDERed recruitment method is safe?

Research has shown that the ORDERed recruitment process aims to improve how women are invited to join stroke research studies. This method remains safe as it involves no medical treatments or procedures. Instead, it uses tools like brochures and videos to make the recruitment process more inclusive and easier to understand, especially for women. The study seeks to determine if this approach encourages more participation in stroke research. Without involving medical treatment, there are no known side effects. Participants can expect a clear and supportive experience without any safety risks.12345

Why are researchers excited about this trial?

Researchers are excited about the ORDERed recruitment process because it aims to enhance the way participants, especially women and those with aphasia, are engaged in stroke research. Unlike traditional recruitment methods that rely solely on written information, ORDERed integrates a more inclusive approach by using video and brochures designed to be women-centered and aphasia-friendly. This new method could lead to a more diverse and representative participant pool, potentially improving the outcomes and applicability of stroke research findings.

What evidence suggests that the ORDERed recruitment process is effective for stroke research?

Research has shown that innovative recruitment methods, such as the ORDERed toolkit, might increase participation in stroke studies, particularly among women. This trial will recruit participants using either traditional methods or the ORDERed approach. A review of typical recruitment strategies for stroke trials found that traditional methods often fall short, with only about one-third of stroke survivors agreeing to participate. The ORDERed approach employs materials tailored for women and resources that are accessible to those with communication difficulties, aiming to address these challenges. Although specific data on ORDERed's effectiveness is limited, similar methods have shown promise in enhancing recruitment, suggesting it could improve participation and foster more inclusive research.13467

Are You a Good Fit for This Trial?

This trial is for anyone seen in urgent stroke or TIA clinics, or referred from the emergency department with suspected minor stroke or TIA within Canada. People are excluded if their stroke was due to trauma, a mass, certain blood vessel problems, happened over 14 days ago, or if there’s no clear evidence of stroke on scans.

Inclusion Criteria

I was referred from the emergency room for a possible TIA or minor stroke.
I have had bleeding in my brain.
I have had an ischemic stroke.

Exclusion Criteria

Imaging abnormality (e.g., dissection, carotid stenosis, vessel irregularity) without imaging or clinical evidence of stroke
Stroke initially treated outside of Canada
I have had bleeding under the outer layer of my brain (subdural hemorrhage).
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Recruitment

Participants are recruited using traditional and ORDERed methods, including a women-centred, aphasia-friendly recruitment process

Up to 30 days
Initial contact and decision-making interactions

Follow-up

Participants are monitored for enrollment effectiveness and feedback is collected through surveys

4 weeks
Web-based survey at enrollment decision

What Are the Treatments Tested in This Trial?

Interventions

  • ORDERed

Trial Overview

The study compares a new women-focused and aphasia-friendly recruitment process (ORDERed), using easy-to-understand materials co-designed with patients, against traditional ways of recruiting people into stroke research. The goal is to see which method helps more people join studies.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Traditional Recruitment Processes (TRADITIONAL)Experimental Treatment1 Intervention
Group II: Supported, women-centred and aphasia-friendly recruitment process (ORDERed)Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

McMaster University

Lead Sponsor

Trials
936
Recruited
2,630,000+

Citations

ORDERed Recruitment for Stroke Research ...

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Optimized Recruitment to Drive Equitable Research in Stroke ...

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A systematic review of the efficiency of recruitment to stroke ...

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Recruitment challenges in stroke neurorecovery clinical trials

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Recruitment Methods for Stroke Rehabilitation

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Recruitment in Acute Stroke Trials: Challenges and Potential ...

Recruitment in all competing trials decreased unless co-enrollment feasible; investigator confusion between trials; patient fatigue if approached for multiple ...

Recruitment to multicentre randomised controlled trials in ...

Safety and efficacy of fluoxetine on functional recovery after acute stroke (EFFECTS): a randomised, double-blind, placebo-controlled trial.