School of Medicine and Public Health, Faculty of Health and Medicine, The University of Newcastle, 1 University Drive, Callaghan, NSW, 2308, Australia.
Hunter Medical Research Institute (HMRI), New Lambton Heights, NSW, 2305, Australia.
Trials. 2019 Aug 9;20(1):491. doi: 10.1186/s13063-019-3604-0.
Recurrent stroke is a major contributor to stroke-related disability and costs. Improving health-risk behaviours and mental health has the potential to significantly improve recovery, enhance health-related quality of life (HRQoL), independent living, and lower the risk of recurrent stroke. The primary aim will be to test the effectiveness of an online intervention to improve HRQoL among stroke survivors at 6 months' follow-up. Programme effectiveness on four health behaviours, anxiety and depression, cost-effectiveness, and impact on other hospital admissions will also be assessed.
METHODS/DESIGN: An open-label randomised controlled trial is planned. A total of 530 adults will be recruited across one national and one regional stroke registry and block randomised to the intervention or minimal care control group. The intervention group will receive access to the online programme Prevent 2nd Stroke (P2S); the minimal care control group will receive an email with Internet addresses of generic health sites designed for the general population. The primary outcome, HRQoL, will be measured using the EuroQol-5D. A full analysis plan will compare between groups from baseline to follow-up.
A low-cost per user option to supplement current care, such as P2S, has the potential to increase HRQoL for stroke survivors, and reduce the risk of second stroke.
Australian and New Zealand Clinical Trials Registry, ID: ACTRN12617001205325p . Registered on 17 August 2017.
复发性中风是导致中风相关残疾和费用的主要因素。改善健康风险行为和心理健康状况，有可能显著改善康复效果，提高健康相关生活质量（HRQoL），提高独立生活能力，并降低再次中风的风险。主要目的是测试在线干预措施在 6 个月随访时改善中风幸存者 HRQoL 的效果。还将评估该方案对四项健康行为、焦虑和抑郁、成本效益以及对其他住院治疗的影响。
方法/设计：计划进行一项开放性标签随机对照试验。将从一个国家和一个地区的中风登记处招募 530 名成年人，并将其随机分为干预组或最低关怀对照组。干预组将获得在线预防第二中风项目（P2S）的访问权限；对照组将收到一封电子邮件，其中包含为一般人群设计的通用健康网站的互联网地址。主要结局指标是使用 EuroQol-5D 来衡量 HRQoL。将从基线到随访进行全面分析计划，以比较两组之间的差异。
作为对当前护理的补充，这种低成本的每位用户选择（如 P2S），有可能提高中风幸存者的 HRQoL，并降低再次中风的风险。
澳大利亚和新西兰临床试验注册处，注册号：ACTRN12617001205325p。于 2017 年 8 月 17 日注册。
