ACTRN12624001168549尚未招募Unknown
Digital technologies for stroke prevention: a randomised controlled trial evaluating the effectiveness of blood pressure reduction in individuals aged 35 years or older diagnosed with TIA or minor stroke
适应症
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 360
- 主要终点
- Change in systolic blood pressure[Automated digital sphygmomanometer At baseline and 6-months post randomisation (plus 4 weeks or minus 2 weeks)]
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Prevention
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 35 Years 至 85 Years(—)
- 性别
- All
入选标准
- •People aged 35-85 years old diagnosed with TIA or minor stroke (including recurrent events) with ambulant modified Rankin Scale (mRS) score 0-3 at discharge or independent in activities of daily living in the past 90 days.
- •Admitted to one of the two Auckland based hospitals or identified via outpatient clinics or primary care for minor stroke or TIA.
- •Can converse in English.
- •Systolic blood pressure greater than or equal to 130 mmHg, or greater than or equal to 120 mmHg if on blood pressure medications.
- •Has access to a Smartphone or Smart Device (iPad, Tablet).
- •Provides written informed consent.
排除标准
- •History of major stroke, subarachnoid haemorrhage or major myocardial infarction (verified through Clinical Portal medical records)
- •Life-threatening conditions with a life-expectancy less than 5 years.
- •Current (in the past year) significant clinical depression/anxiety measured by the Hospital Anxiety and Depression questionnaire (HADS) at a level greater than or equal to 14 in either or both the depression and anxiety domains (either in clinical records or at screening) OR psychiatric conditions (based on medical records).
- •History (past year) of alcohol or drug/ substance abuse.
- •Dependent on others (living in a rest-home/care facility).
- •Unable to have telephone assessments due to hearing difficulties.
- •Significant cognitive impairment or pre-existing diagnosis of dementia, e.g., at screening (T-MoCA less than 15). People with less than 12 years education and those for whom English is not the first language will score an additional point for each circumstance.
- •Participation in another current RCT or major research study.
结局指标
主要结局
Change in systolic blood pressure[Automated digital sphygmomanometer At baseline and 6-months post randomisation (plus 4 weeks or minus 2 weeks)]
次要结局
未报告次要终点
研究者
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