Picture This: A Randomized Controlled Pilot Study Investigating Adherence to Blood Pressure Diaries With Personalized Visuals
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Adherence
研究概览
简要总结
This trial randomizes patients with a neurovascular diagnosis to a type of blood pressure diary for secondary stroke prevention (conventional blood pressure diary or blood pressure diary including patient-provided images). Outcomes include adherence and patient-reported outcomes.
详细描述
In this prospective trial, the investigators randomized persons with diagnoses of stroke or transitoric ischemic attack into two groups: (i) 10 patients received a personalized blood pressure diary with pictures of their choosing. (ii) 10 patients received a blood pressure diary without photographs. The investigators instructed participants in either group to document their blood pressure at home twice daily over twenty-eight days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of TIA or stroke (ischemic or hemorrhagic) upon admission.
排除标准
- •Modified Rankin Scale score of ≥4 at inclusion
- •Inability to provide informed consent
- •Pre-existing legal guardianship.
研究组 & 干预措施
Conventional blood pressure diary
Blood pressure diaries consisted of tables including columns for date, time as well as systolic and diastolic blood pressure respectively (1 page for 1 week) printed on the right-hand pages of an A5 (ISO 216 format) booklet.
干预措施: Conventional blood pressure diary (Other)
Blood pressure diary including patient-provided pictures
In the interventional arm pictures chosen by patients were provided over a secure online connection by patients in this group and inserted into the left-hand-pages of the blood pressure diaries.
干预措施: Inclusion of patient-provided pictures into blood pressure diaries (Other)
结局指标
主要结局
Adherence
时间窗: 28 days
The primary endpoint was adherence to blood pressure diaries defined as the number of complete blood pressure measurements (maximum of two per day) divided by the maximum number of measures over the study period (28 days, resulting in a maximum total of 56 measurements). Complete entries were defined as diary entries stating date, time and systolic as well as diastolic blood pressure.
次要结局
- Blood pressure(28 days)
- Patient Global Impression of Change Scale(28 days)
- Hospital Anxiety and Depression Scale(28 days)
- Precision of documentation of blood pressure(28 days)
- 36-Item Short Form Health Survey(28 days)
研究者
Clemens Farr
MD PhD
Medical University of Vienna