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

30 апреля 2026 г. обновлено: 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.

Обзор исследования

Статус

Еще не набирают

Условия

Вмешательство/лечение

Подробное описание

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.

Тип исследования

Интервенционный

Регистрация (Оцененный)

1600

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Контакты исследования

  • Имя: Ada Tang, PT PhD
  • Номер телефона: 905-525-9140
  • Электронная почта: atang@mcmaster.ca

Учебное резервное копирование контактов

  • Имя: Hanna Fang
  • Номер телефона: 905-525-9140
  • Электронная почта: fangh@mcmaster.ca

Места учебы

  • Канада
    • Alberta
      • Calgary, Alberta, Канада
        • Foothills Medical Centre
        • Главный следователь:
          • Aravind Ganesh, MD
        • Контакт:
    • British Columbia
      • Vancouver, British Columbia, Канада
        • Vancouver General Hospital
        • Контакт:
        • Главный следователь:
          • Lily Zhou, MD
    • Ontario
      • Toronto, Ontario, Канада, M4N 3M5
        • Sunnybrook Health Sciences Centre
        • Главный следователь:
          • Amy Yu, MD
        • Контакт:

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

  • Ребенок
  • Взрослый
  • Пожилой взрослый

Принимает здоровых добровольцев

Нет

Описание

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

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Другой
  • Распределение: Нерандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Нет (открытая этикетка)

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Другой: Traditional Recruitment Processes (TRADITIONAL)
Traditional participant information letter and consent form only
Другой: 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.
Экспериментальный: 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)
Другой: 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.

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Effectiveness - Enrollment rate
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Feasibility - Reach
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

McMaster University

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Оцененный)

1 апреля 2026 г.

Первичное завершение (Оцененный)

1 августа 2029 г.

Завершение исследования (Оцененный)

1 августа 2029 г.

Даты регистрации исследования

Первый отправленный

21 апреля 2026 г.

Впервые представлено, что соответствует критериям контроля качества

30 апреля 2026 г.

Первый опубликованный (Действительный)

8 мая 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

8 мая 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

30 апреля 2026 г.

Последняя проверка

1 апреля 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • ORDERed

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

НЕТ

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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