The Tele-Taking Charge After Stroke (TeleTaCAS) Randomized Controlled Feasibility Trial of Telehealth Take Charge vs Control
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Rate of recruitment
研究概览
简要总结
Take Charge is a novel, community-based treatment for stroke developed to harness a person's self-determination. Two prior clinical trials with 572 stroke survivors showed that Take Charge improves quality of life, independence, and social participation up to a year after stroke. Take Charge has also been shown to be overall cost-saving to the health system and is a useful adjunct to standard care after stroke.
Because of the COVID-19 pandemic, a lot of healthcare has moved into a telehealth approach. The simplicity of Take Charge may lend itself to being effective if delivered by telehealth, allowing greater access for people with stroke in rural communities. Improving the care we provide in underserved regions of the country is important to help the health of Canadians.
We are proposing a new study, working closely with the researchers who ran the previous Take Charge studies.
The goal of this feasibility clinical trial is to learn about Tele-Take Charge in adults with stroke who live in Southern Alberta. The main questions it aims to answer are:
- is delivering Take Charge by telehealth feasible?
- is Take Charge by telehealth acceptable to this population?
Participants will meet with facilitators online via Zoom at 4 to 16 weeks after stroke, and be randomized to receive either:
- two Tele-Take Charge sessions six weeks apart
- one control tele-education session.
Researchers will compare the Tele-Take Charge and control groups to see if there are any differences in outcome measures. these differences will help researchers to estimate the number of participants that will be needed for a larger, multi-centred effectiveness trial.
详细描述
For adults diagnosed with acute stroke who are discharged to community living (non-institutionalized), we wish to evaluate whether delivering two Take Charge sessions by telehealth is (1) acceptable to the population of Southern Alberta, and (2) feasible to do.
Subjects will be randomly assigned to receive either two Tele-Take Charge sessions or one tele-education session (Life After Stroke video) by telehealth (the active control).
The primary feasibility outcome will be recruitment rate. Secondary outcomes will be measured by a blinded outcomes assessor at 6 and 12 months, either by e-questionnaire or by telephone.
Those who received Tele-Take Charge will also be asked to complete an acceptability questionnaire, and will be invited to take part in an in-depth interview about their experience as part of a qualitative substudy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Discharged with diagnosis of stroke to non-institutionalised community living situation
- •Answering 'No' to the question 'Are you fully recovered from your stroke?' (i.e., modified Rankin score [mRS] must be > 0)
- •Able to access video calling with a smartphone, computer, or other device
排除标准
- •Major comorbid illness that would dictate functional outcome at 12 months or life expectancy < 12 months
- •Pre-stroke dependency (mRS > 2 before index stroke)
结局指标
主要结局
Rate of recruitment
时间窗: 12 months
Number of participants recruited per month
次要结局
- Eligibility(12 months)
- Treatment adherence(12 months)
- Activities of Daily Living - Barthel Index(6 and 12 months after stroke)
- Instrumental Activities of Daily Living / Social Participation - Frenchay Activities Index(6 and 12 months after stroke)
- Acceptability of Tele-TaCAS(2 weeks after receiving Tele-TaCAS)
- Health-related quality of life(6 and 12 months after stroke)
- Quality of Life - EQ5D5L(6 and 12 months after stroke)
- Independence - modified Rankin scale 0 to 2(6 and 12 months after stroke)
- Self-Determination - AMP-C(6 and 12 months after stroke)
研究者
Dr. Sean Dukelow
Associate Professor
University of Calgary