Comparing Traditional recruitment and enrollment with Supported, women-centred and for stroke
Official title: Optimizing Recruitment to Drive Equitable Research Opportunity in Stroke Rehabilitation Trials in Canada
Optimizing Recruitment to Drive Equitable Research Opportunity in Stroke Rehabilitation in Canada - The ORDER Pilot Study
- 2 groups
- Sites in Calgary, Vancouver and 3 more cities
- Recruiting
Interventions
- Other intervention
Supported, women-centred and aphasia-friendly recruitment and enrollment process (ORDER)
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.
- Other intervention
Traditional recruitment and enrollment processes (TRAD)
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.
Canadian Sites (5)
4 of 5 recruiting
- Recruiting
University of Calgary & Foothills Medical Centre
Calgary, Alberta
- Recruiting
University of British Columbia & GF Strong Rehabilitation Centre
Vancouver, British Columbia
- Recruiting
Dalhousie University
Halifax, Nova Scotia
- Recruiting
Parkwood Institute
London, Ontario
- Not yet recruiting
Toronto Rehabilitation Institute - University Health Network
Toronto, Ontario
Eligibility Criteria
See who this study is looking for22 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Age ≥18 years
- +Primary ischemic anterior circulation stroke
- +≥5 days but \<8 weeks after stroke on the date of medication (Maraviroc or placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more →) start
- +Hemiparesis requiring inpatient rehabilitation
- +Assistance available for daily rehabilitation training practice and for transportation when needed
- +Adequate language skills to understand Informed ConsentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → 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
Exclusion
- −History of hepatitis or elevated hepatic transaminases or bilirubin
- −Known HIV positivity
- −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 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
- −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
- −Pregnant, breastfeeding, or positive test for pregnancy at baselineBaselineYour starting measurements, taken before treatment begins.Read more →
- −Women of childbearing potential who are not using one highly effective form of contraception or two forms of effective contraception
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study does not fall into the standard research categories.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives Traditional recruitment and enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more → processes (TRAD).
Registry label: A: Traditional recruitment and enrollment processes (TRAD)
Group B receives Supported, women-centred and aphasia-friendly recruitment and enrollment process (ORDER).
Registry label: B: Supported, women-centred and aphasia-friendly recruitment and enrollment process (ORDER)
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
One group of people involved — usually the participants — is not told which treatment is which.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 120 people.
The study is currently expected to finish around June 2027.
The main measurement is taken over: From date identified as eligible for the host trial to date of decision (consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → or decline).
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Feasibility — measured over From date identified as eligible for the host trial to date of decision (consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → or decline).
Barriers and facilitators — measured over From date of decision (consent or decline) for host trial to date of survey or interview.
Preliminary estimates of effect — measured over From date identified as eligible for the host trial to date of decision (consent or decline).
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06576089 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About 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.
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
About 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.
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
One group of people involved — usually the participants — is not told which treatment is which.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: From date identified as eligible for the host trial to date of decision (consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → or decline).
The study as a whole is currently expected to finish around 2027-06-30.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 120 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 5 locations, including: Calgary, Alberta, Canada; Vancouver, British Columbia, Canada; Halifax, Nova Scotia, Canada; London, Ontario, Canada; Toronto, Ontario, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
Think this trial might be right for you?
Complete a quick intake form and we will match you with this and other relevant trials based on your medical profile.
See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.