Optimizing Recruitment to Drive Equitable Research Opportunity in Stroke Rehabilitation in Canada - The ORDER Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 10
- 主要终点
- Barriers and facilitators
研究概览
简要总结
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.
详细描述
Clinical trials in stroke recovery are essential for establishing effective treatments, yet important groups, such as women and people with aphasia, have been consistently under-represented in stroke trials. This limits the generalizability of trial findings and impacts clinical care. Relevant to stroke is the critical time window for neuroplastic change that makes timely enrolment into stroke recovery trials of particular importance. There is a need to develop strategies to efficiently and effectively promote participation into stroke recovery trials.
The Optimizing Recruitment to Drive Equitable Research opportunity in stroke rehabilitation trials in Canada (ORDER) is a pilot "study within a trial" to look at a women-centred, aphasia-friendly recruitment method for a research trial examining whether a medication (Maraviroc), when combined with rehabilitation, can help with stroke recovery ("host trial").
The objectives of this pilot study are to:
- Examine the feasibility of a women-centred, aphasia-friendly video and leaflet (ORDER) to supplement traditional detailed participant information letters, support recruitment, and drive enrollment in a stroke recovery randomized trial;
- Understand the barriers and facilitators associated with enrolling in the host trial and stroke recovery trials more broadly;
- Determine preliminary estimates of effect of ORDER compared to traditional recruitment and enrollment processes
The study will take place at the 10 sites across 6 provinces. The host trial is comparing Maraviroc vs. placebo, combined with 8 weeks of rehabilitation, to improve motor and sensory function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary ischemic anterior circulation stroke
- •Age ≥18 years
- •≥5 days but <8 weeks after stroke on the date of medication (Maraviroc or placebo) start
- •Hemiparesis requiring inpatient rehabilitation
- •Assistance available for daily rehabilitation training practice and for transportation when needed
- •Adequate language skills to understand Informed Consent 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
排除标准
- •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 hepatitis or elevated hepatic transaminases or bilirubin
- •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
- •Pregnant, breastfeeding, or positive test for pregnancy at baseline
- •Women of childbearing potential who are not using one highly effective form of contraception or two forms of effective contraception
- •Known HIV positivity
- •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
结局指标
主要结局
Barriers and facilitators
时间窗: From date of decision (consent or decline) for host trial to date of survey or interview
Short survey and semi-structured interviews to examine the perceptions of the enrollment and consent process of individuals approached to participate in CAMAROS and Site Coordinators. Reason(s) for declining to participate and recruitment reach (# and characteristics of individuals approached for CAMAROS) will also be recorded.
Preliminary estimates of effect
时间窗: From date identified as eligible for the host trial to date of decision (consent or decline)
Each site will record # patients approached, # consented (by men and women), date of initial contact by the Site Coordinator, date of decision (consent or decline), and # interactions between the Site Coordinator and potential participants for ORDER and TRAD.
Feasibility
时间窗: From date identified as eligible for the host trial to date of decision (consent or decline)
Each site will record # patients approached, # consented (by men and women), date of initial contact by the Site Coordinator, date of decision (consent or decline), and # interactions between the Site Coordinator and potential participants for ORDER and TRAD.
次要结局
未报告次要终点
研究者
Ada Tang
Professor, Assistant Dean
McMaster University