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

30 aprile 2026 aggiornato da: Ada Tang, McMaster University
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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Women are under-represented in stroke research, ranging from acute stroke clinical trials, prevention, and rehabilitation studies, limiting the generalizability of research findings and impacting clinical care. Studies have found that women were more likely to be missed by recruiters, and when approached, were more likely to decline participation. Women are also more likely to consider the opinions of their spouse or friends when deciding to participate in studies. Data from the EMPOW-HER study suggest that women have more unanswered questions than men from the consent form and altruism is a greater motivator for research participation among women. This new knowledge led to the development of the ORDER toolkit, a women-centred and aphasia-friendly recruitment and enrollment toolkit that can be broadly applied to stroke studies. This study will investigate its effectiveness in the enrollment process of the StrokeGoRed (ORDERed).

ORDERed will use a pre-post design embedded within StrokeGoRed (Stroke in Women: Growing Opportunities to Realize optimal Evaluation, Diagnosis, and outcomes (StrokeGoRed)) to test the use of a supported, women-centred and aphasia-friendly recruitment and enrollment process.

The objectives of this study are to:

  1. Examine the effectiveness (enrollment rate, efficiency, and attrition) of a women-centred, aphasia-friendly recruitment and enrollment process (ORDERed) compared to traditional processes (TRADITIONAL);
  2. Understand barriers and facilitators associated with enrolling in the host cohort study and stroke studies more broadly; and
  3. Evaluate the feasibility (reach, adoption, implementation, and maintenance) of ORDERed.

ORDERed will use a pre-post design embedded within StrokeGoRed (Stroke in Women: Growing Opportunities to Realize optimal Evaluation, Diagnosis, and outcomes (StrokeGoRed)) to test the use of a supported, women-centred and aphasia-friendly recruitment and enrollment process. The site will begin with the usual enrollment process (TRADITIONAL) for the first part of the recruitment period (study letter and informed consent form), followed by the ORDERed toolkit for the latter half of the recruitment period.

The RE-AIM implementation science framework, consisting of five steps to translate research into action, will be used to evaluate the implementation of ORDERed. Traditional and ORDERed will be compared for Reach and Effectiveness, including enrollment rate (consented participants divided by total approached), efficiency (number of days and interactions between initial contact to decision to participate), and attrition (lost to follow-up divided by total enrolled) using a descriptive analysis stratified by sex. At the time of decision, participants will also be invited to complete a brief 15-minute web-based survey regarding the recruitment process and their decision making regarding participating in the study, including reason(s) for not participating. After the recruitment period, Coordinators will be invited to complete a survey about their perspectives of the Adoption of the ORDER toolkit, Implementation (consistency in using the toolkit, efficiency metrics), and Maintenance (coordinators will be asked whether they would use this for future studies and potential barriers to implementation in future studies).

To assess the effectiveness of the ORDERed intervention compared with traditional recruitment methods, a logistic regression model will be used with a binary outcome indicating successful recruitment. Treatment group (ORDER vs. traditional recruitment) will be the primary independent variable, and prespecified covariates (e.g., age, sex, gender) will be included as adjustment variables. The analysis will be repeated stratified by sex.

Tipo di studio

Interventistico

Iscrizione (Stimato)

1600

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Canada
    • Alberta
      • Calgary, Alberta, Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Vancouver General Hospital
        • Contatto:
        • Investigatore principale:
          • Lily Zhou, MD
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Altro
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Altro: Traditional Recruitment Processes (TRADITIONAL)
Traditional participant information letter and consent form only
Altro: 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.
Sperimentale: 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)
Altro: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Effectiveness - Enrollment rate
Lasso di tempo: From initial contact with study coordinator to decision to participate (up to 30 days)
Consented participants divided by total approached
From initial contact with study coordinator to decision to participate (up to 30 days)
Effectiveness - Efficiency
Lasso di tempo: From initial contact with study coordinator to decision to participate (up to 30 days)
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
Lasso di tempo: At time of enrollment decision to the StrokeGoRed study (consent or decline)
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)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Feasibility - Reach
Lasso di tempo: At the end of the recruitment period
Coordinators will be invited to complete a survey to examine Reach of the ORDER toolkit (Coordinator demographics and needs), and Adoption, Implementation (consistency in using the toolkit, efficiency metrics), and Maintenance (whether they would use toolkit for future studies and potential barriers to implementation in future studies)
At the end of the recruitment period
Feasibility - Adoption
Lasso di tempo: At the end of the recruitment period
Coordinators will be invited to complete a survey to examine Reach of the ORDER toolkit (Coordinator demographics and needs), and Adoption, Implementation (consistency in using the toolkit, efficiency metrics), and Maintenance (whether they would use toolkit for future studies and potential barriers to implementation in future studies)
At the end of the recruitment period
Feasibility - Implementation
Lasso di tempo: At the end of the recruitment period
Coordinators will be invited to complete a survey to examine Reach of the ORDER toolkit (Coordinator demographics and needs), and Adoption, Implementation (consistency in using the toolkit, efficiency metrics), and Maintenance (whether they would use toolkit for future studies and potential barriers to implementation in future studies)
At the end of the recruitment period
Feasibility - Maintenance
Lasso di tempo: At the end of the recruitment period
Coordinators will be invited to complete a survey to examine Reach of the ORDER toolkit (Coordinator demographics and needs), and Adoption, Implementation (consistency in using the toolkit, efficiency metrics), and Maintenance (whether they would use toolkit for future studies and potential barriers to implementation in future studies)
At the end of the recruitment period

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

McMaster University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 aprile 2026

Completamento primario (Stimato)

1 agosto 2029

Completamento dello studio (Stimato)

1 agosto 2029

Date di iscrizione allo studio

Primo inviato

21 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

30 aprile 2026

Primo Inserito (Effettivo)

8 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

8 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

30 aprile 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • ORDERed

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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