OPTIMA-BP: Empowering PaTients in MAnaging Blood Pressure
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- HBPM systolic blood pressure (SBP) area under the curve (AUC)
研究概览
简要总结
Hypertension is the leading modifiable risk factor for cardiovascular disease and is implicated in half of all strokes and myocardial infarctions. One-third of adults in Scotland have hypertension yet only one-quarter of these have their blood pressure (BP) controlled to target (<140/90 mmHg). Reasons for the low rate of control are varied but include individuals lack of confidence, knowledge and understanding of the condition and treatment strategy, non-adherence to medication and infrequent BP monitoring. These issues have been compounded by the ongoing COVID-19 pandemic which has brought changes in routine BP screening, access to medical care and chronic disease management in primary and secondary care, shielding of the highest risk groups and a change in health and research focus. Shared decision making and issues around health literacy were highlighted by the Scottish Government Cross Party Group on Heart Disease and Stroke: High Blood Pressure Task Force in 2019. Empowering patients to have a better understanding of their condition and becoming actively involved in the monitoring and management of hypertension may lead to improved patient satisfaction, improved BP control and health outcomes and reduction in the use of primary/secondary care hypertension clinics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Current attendance at the GBPC
排除标准
- •Inability to give informed consent
- •Non-English speakers
- •No internet access
- •Clinic or ambulatory blood pressure ≥180/120 mmHg
- •Arm circumference >42cm
- •Inability to perform HBPM
- •Inability to use Kvatchii portal
- •Pregnancy
- •Persistent atrial fibrillation
- •Acute cardiovascular event requiring hospitalisation in the previous 3 months
- •CKD stage ≥4 or renal dialysis
- •Severe or terminal illness limiting study participation
结局指标
主要结局
HBPM systolic blood pressure (SBP) area under the curve (AUC)
时间窗: Baseline and 6 months
HBPM systolic blood pressure (SBP) area under the curve (AUC)
次要结局
- Change in quality of life measured by the generalised anxiety disorder 7 item scale (GAD-7)(Baseline, 6 months and 12 months)
- Change in quality of life measured by EQ-5D-5L questionnaire(Baseline, 6 months and 12 months)
- Change in antihypertensive medicine adherence measured by the Hill-Bone compliance to High Blood Pressure Therapy Scale (HB-HBP)(Baseline, 6 months and 12 months)
- Evaluation of the Kvatchii portal measured by system usability scale (SUS)(over the course of 24 months)
- HBPM diastolic blood pressure (DBP) under the curve (AUC)(Baseline and 12 months)
- Change in health literacy measured by BRIEF: Health literacy Screening Tool(Baseline, 6 months and 12 months)
- Change in knowledge of hypertension measured by Blood Pressure Knowledge questionnaire(Baseline, 6 months and 12 months)
- HBPM systolic blood pressure (SBP) under the curve (AUC)(Baseline and 12 months)
- Change in quality of life measured by Patient Health Questionnaire (PHQ-9) questionnaire(Baseline, 6 months and 12 months)
- Change in lifestyle measured by lifestyle questionnaire(Baseline, 6 months and 12 months)
- Antihypertensive medication changes(Baseline, 6 months and 12 months)