Rehabkompassen® - a Novel Digital Tool for Facilitating Patient-tailored Rehabilitation in the Post-acute Continuum of Care After Stroke - A Multicenter Pragmatic Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,106
- 试验地点
- 2
- 主要终点
- Social activities
研究概览
简要总结
Stroke is a leading cause of disability and with a heavy burden for the society. Despite the demands from 'Socialstyrelsen' of improving post-acute care, an effective structured follow-up to promote a patient-tailored rehabilitation remains largely lacking in the current stroke care.
The overall aim of this study is to find a cost-effective solution to facilitate patient-tailored rehabilitation that improves daily and social activities and health-related quality of life for persons discharged from the acute care after stroke. We have recently developed a novel digital graphic tool, Rehabkompassen®, which based on patient-reported outcome measurements captures the patient's complex health status after stroke.
Here, this tool will be used in a parallel, open-label, 2-arm prospective and multicenter pragmatic randomized controlled trial between 2022-2026. All participants (n = 1106) will be randomized according to permuted block design; and receive a usual care without (control group, n = 553) or with (intervention group, n = 553) Rehabkompassen®, within 3-month after stroke. The effectiveness of the tool on daily and social activities, quality of life and its health-economic effects will be compared at 12-month follow-up post stroke.
We hypothesize that the digital tool Rehabkompassen® will provide a patient-tailored rehabilitation that improves recovery, independence, and quality of life among people with stroke in a cost-effective way.
详细描述
Primary research question Does the incorporation of the digital Rehabkompassen® tool in usual care within 3 months after stroke onset result in improved daily and social activities for patients at the 12-month follow-up after stroke onset compared to those receiving usual care with the Post-Stroke Checklist (PSC)?
Secondary research questions
The aim is to investigate the following by comparing usual care with the PSC ® (control group) to usual care with the usage of the digital Rehabkompassen® tool:
- The improvement of technical and methodological aspects of Rehabkompassen® based on feedback from end-users, including both patients and health care practitioners.
- The provision of information that affects and/or facilitates the implementation of the Rehabkompassen® tool.
- The facilitation of triage, clinical assessments, decision-making, the development of a rehabilitation plan, referrals, and outcome evaluations for health care professionals.
- The influence on secondary outcome measures, including fatigue, depression, anxiety, and other stroke impacts, at the 12-month poststroke follow-up.
- The impact on patients' health-related quality of life at the 12-month follow-up after stroke onset
- The demonstration of the cost-effectiveness of the tool.
Study design and patient selection.
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
- None
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Social activities
时间窗: 12 months follow-up after stroke
Stroke Impact Scale 3.0 (SIS)-participation (SIS-p) will be used to measure social activities. SIS-p is the dominant problem among persons after stroke reported in previous Swedish stroke RCTs; but not covered by smRSq. The SIS-p score ranges from 0-100 and the higher the score the less impact of stroke.
Daily activities
时间窗: 12 months follow-up after stroke
The simplified modified Rankin Scale questionnaire (smRSq) will be used to measure daily activities and functional status. The smRSq is based on the yes/no responses to five questions, which in turn results an ordinal data of seven categories (0-6) of the modified Rankin Scale. A favorable outcome will be defined as mRS score of 0-2 (no symptoms to independent but with minor disability). A poor outcome will be defined as mRS score of 3-5 (disability but able to walk to bed-bound and in need of full nursing care) or 6 (death).
次要结局
- End-users' experiences and feedback(3 months follow-up after stroke)
- Health-economic evaluation(12 months follow-up after stroke)
- Health-related quality of life(12 months follow-up after stroke)
- Stroke impacts(12 months follow-up after stroke)
- Clinicians' usability(3 months follow-up after stroke)