Ortiz-Fernández Leire, Sagastagoya Zabala Joana, Gutiérrez-Ruiz Agustín, Imaz-Ayo Natale, Alava-Menica Ander, Arana-Arri Eunate
Osakidetza-Basque Health Service, Biocruces Bizkaia Health Research Institute, Cruces University Hospital, Plaza Cruces 12, 48903 Barakaldo, Spain.
Biocruces Bizkaia Health Research Institute Plaza Cruces 12, 48903, Barakaldo, Spain.
Methods Protoc. 2019 Jun 13;2(2):50. doi: 10.3390/mps2020050.
Stroke is a leading cause of severe and long-term disability in developed countries. Around 15 million people suffer a stroke each year, being most of them ischemic due to modifiable risk factors. Adequate self-management abilities may help to manage the consequences of stroke, but it is unknown which specific intervention could be effective to booster these self-management abilities.
To evaluate the improvement of self-management in chronic stroke survivors using decision support and self-management system (STARR).
A randomized, prospective, parallel group, open, and the unicentric pilot trial will be performed. Stroke survivors and their caregivers will be randomly allocated to STARR management or standard of care. Main inclusion criteria are mild to moderate disabled first stroke adult survivor, living at home, able to cope and follow the guidelines and devices, without socio-familial exclusion. All will get a conventional treatment in the acute and subacute phase; however, in the chronic period, cases will use the developed STARR App and Decision Support System. Measurements will be performed at baseline, at 3 months, and at 6 months. Outcome measures are patient-report outcome measure of self-management competency, physical function, risk factor reduction, healthcare resource utilization, knowledge of the condition, mood, and social isolation.
If effective, the results of this study will enable stroke patients and their caregivers to deal better with the everyday life obstacles of stroke, improve the adherence of the treatment, improve the control of cardiovascular risk, and, in consequence, reduce the recurrence of secondary strokes, the number of complications, the number of consultations, and readmissions; to ultimately reduce the health systems costs. Taking into consideration that the number of stroke survivors is increasing around the world, a large number of individuals could profit from this intervention.
在发达国家，中风是导致严重长期残疾的主要原因。每年约有1500万人中风，其中大多数是缺血性中风，这是由可改变的风险因素引起的。足够的自我管理能力可能有助于应对中风的后果，但尚不清楚哪种具体干预措施能有效提高这些自我管理能力。
评估使用决策支持和自我管理系统（STARR）对慢性中风幸存者自我管理的改善情况。
将进行一项随机、前瞻性、平行组、开放性单中心试点试验。中风幸存者及其护理人员将被随机分配到STARR管理组或标准护理组。主要纳入标准是轻度至中度残疾的首次中风成年幸存者，居家生活，能够配合并遵循指导方针和使用设备，无社会家庭排斥情况。所有人在急性期和亚急性期都将接受常规治疗；然而，在慢性期，患者将使用开发的STARR应用程序和决策支持系统。将在基线、3个月和6个月时进行测量。结果指标包括自我管理能力、身体功能、风险因素降低、医疗资源利用、病情知识、情绪和社会隔离的患者报告结局指标。
如果有效，本研究结果将使中风患者及其护理人员能够更好地应对中风的日常生活障碍，提高治疗依从性，改善心血管风险控制，从而减少二次中风的复发、并发症数量、会诊次数和再入院次数；最终降低卫生系统成本。考虑到全球中风幸存者数量在增加，大量个体可能从这种干预中受益。
