Recruitment Methods for Stroke Rehabilitation

(ORDER-P Trial)

Recruiting at 4 trial locations

Overseen By Hanna Fang

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: McMaster University

Must not be taking: Anticonvulsants, Antifungals, Antibiotics, St. John's Wort

Disqualifiers: Dementia, Cancer, Epilepsy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to enhance recruitment for stroke rehabilitation studies, focusing on women and individuals with aphasia (a language impairment after stroke). It compares traditional recruitment methods with a new, more supportive approach called ORDER: Supported, women-centered, and aphasia-friendly recruitment and enrollment process. This approach includes videos and leaflets tailored for these groups. Individuals who have experienced an ischemic stroke and need rehabilitation may be suitable candidates, particularly if they have some mobility and support for daily therapy. The goal is to ensure research findings better represent everyone affected by stroke. As an unphased trial, this study provides a unique opportunity to contribute to research that seeks to improve recruitment processes, making future studies more inclusive and effective.

Will I have to stop taking my current medications?

The trial requires you to stop taking certain medications, including specific anticonvulsants, antifungals, antibacterials, and St. John's Wort. If you are on these, you would need to discontinue them to participate.

What prior data suggests that this recruitment method is safe for stroke patients?

Research has shown that the ORDER method, a new way to recruit participants, is safe and easy to use. This method employs a video and leaflet to help women and individuals with aphasia (a language problem after a stroke) understand and join studies more easily. As this approach focuses on improving how people are invited to join trials, no harmful side effects or safety issues have been reported. It aims to make participation in research easier and more inclusive. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative recruitment methods for stroke rehabilitation. Unlike traditional approaches, which rely solely on standard information letters and consent forms, the new method includes a women-centered, aphasia-friendly video and leaflet. This could make the process more inclusive and accessible, especially for women and individuals with communication difficulties. By tailoring the recruitment process to better meet participants' needs, researchers hope to improve enrollment and engagement in rehabilitation programs, which could lead to better outcomes for stroke survivors.

What evidence suggests that this recruitment method is effective for stroke rehabilitation?

Research has shown that traditional methods for recruiting participants in stroke studies often exclude important groups, such as women and individuals with language difficulties (aphasia). This exclusion can reduce the accuracy of study results. In this trial, participants will be assigned to either the "Traditional recruitment and enrollment processes" (TRAD) or the "Supported, women-centered and aphasia-friendly recruitment and enrollment process" (ORDER) method. The ORDER method aims to address this issue. In a test run, ORDER successfully enrolled 42 participants with post-stroke aphasia and retained 83% of them. This outcome suggests that ORDER can enhance participation and retention, making stroke research more representative of all affected individuals. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for Canadians who have had a stroke. It focuses on including women and individuals with aphasia, who often face barriers to participating in research. The goal is to optimize recruitment methods to ensure these groups are represented in studies about stroke rehabilitation.

Inclusion Criteria

Adequate language skills to understand Informed Consent and retain information during daily therapies

I have help for daily rehab exercises and rides when needed.

I can move my shoulder slightly without gravity or can visibly move two or more fingers.

Exclusion Criteria

Limited resources or illness that will not enable a return to living outside of a facility

I had some disability before my stroke.

History of dementia

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

5 days to 8 weeks

Recruitment and Enrollment

Participants are approached and provided with either traditional or women-centred, aphasia-friendly recruitment materials to decide on trial participation

Up to 8 weeks

Multiple interactions with Site Coordinator

Treatment

Participants receive Maraviroc or placebo combined with 8 weeks of rehabilitation to improve motor and sensory function

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

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

Trial Overview The study compares two different ways of recruiting participants: ORDER, which supports women and people with aphasia, making the process easier for them; and TRAD, the traditional way of enrolling people into trials. The aim is to see which method works better for equitable inclusion.

How Is the Trial Designed?

Group I: Traditional recruitment and enrollment processes (TRAD) Experimental Treatment 1 Intervention

Traditional participant information letter and consent form only (TRAD)

Group II: Supported, women-centred and aphasia-friendly recruitment and enrollment process (ORDER) Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

McMaster University

Lead Sponsor

Trials

936

Recruited

2,630,000+

Published Research Related to This Trial

A systematic review of aphasia research datasets revealed significant gaps in participant and intervention details, with only 25.8% of studies reporting prior stroke information and just 2.3% providing socio-economic status, which are crucial for understanding treatment outcomes.

While basic participant demographics like age and sex were commonly reported, the lack of detailed intervention descriptions limits the ability to replicate studies and apply findings in clinical practice, highlighting the need for improved reporting standards in aphasia research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Communicating simply, but not too simply: Reporting of participants and speech and language interventions for aphasia after stroke. [2022]

In a pilot study involving 62 participants with post-stroke aphasia, speech-language telerehabilitation delivered via videoconference showed significant improvements in repetition and sentence production scores compared to usual care alone, indicating potential efficacy in language rehabilitation.

No adverse events were reported during the study, suggesting that telerehabilitation is a safe intervention; however, a larger definitive trial with 230 participants is necessary to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of augmented speech-language therapy delivered by telerehabilitation on poststroke aphasia-a pilot randomized controlled trial. Øra, HP., Kirmess, M., Brady, MC., et al.[2022]

The pilot randomized controlled trial (RCT) successfully recruited 42 participants with post-stroke aphasia, achieving an 83% retention rate, indicating that the SPA intervention is feasible for a larger study.

Participants found the singing groups acceptable and manageable, with high attendance and adherence to the intervention, suggesting that a definitive RCT could effectively assess the impact of the SPA intervention on well-being and social participation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Singing for people with aphasia (SPA): results of a pilot feasibility randomised controlled trial of a group singing intervention investigating acceptability and feasibility. Tarrant, M., Carter, M., Dean, SG., et al.[2021]

Citations

1. withpower.com withpower.com/trial/phase-stroke-8-2024-5d108

Recruitment Methods for Stroke Rehabilitation The pilot randomized controlled trial (RCT) successfully recruited 42 participants with post-stroke aphasia, achieving an 83% retention rate, indicating that ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11842014/

Aphasia partnership training: What outcomes do people with ... The Aphasia Partnership Training (APT) project aimed to identify target outcomes of a new family dyad CPT programme through persons with aphasia (PWA), family ...

3. ichgcp.net ichgcp.net/clinical-trials-registry/NCT06576089

Clinical Trials Registry - ICH GCP Experimental: Supported, women-centred and aphasia-friendly recruitment and enrollment process (ORDER). Supplementing traditional recruitment ...

4. archives-pmr.org archives-pmr.org/article/S0003-9993(23)00368-4/fulltext

Inclusion of People With Aphasia in Stroke Trials Compared with stroke survivors without aphasia, people with aphasia experience poorer outcomes (eg, longer lengths of hospital stay, increased ...

5. bmjopen.bmj.com bmjopen.bmj.com/content/11/8/e050308

Solution Focused Brief Therapy in Post-Stroke Aphasia ... Results Thirty-two participants were recruited, including 43.8% with severe aphasia. Acceptability endpoints: therapy was perceived as valuable and acceptable ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10537631/

Therapies and Challenges in the Post-Stroke Aphasia ... This study provides up-to-date information on (i) effective therapies and aphasia recovery processes, and (ii) research recruitment hurdles ...

7. journals.sagepub.com journals.sagepub.com/doi/10.1177/0269215521995671

Supporting wellbeing through peer-befriending (SUPERB) ... SUPERB peer-befriending for people with aphasia post-stroke experiencing low levels of distress was feasible. There was preliminary evidence of benefit in ...