Community Based Trial of Home Blood Pressure Monitoring With Nurse Led Support in Patients With Stroke or TIA Recently Discharged From Hospital
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 360
- 试验地点
- 6
- 主要终点
- Reduction in systolic blood pressure taken by study team at home visit
研究概览
简要总结
Design: Community based randomised trial with follow up after 12 months Participants: 360 patients admitted with stroke or TIA within the past 9 months will be recruited from the wards or outpatients and randomly allocated into two groups. All patients will be visited by the specialist nurse at home at baseline when she will measure their BP and administer a questionnaire. The questionnaire and BP will be repeated at 12 months follow-up by another researcher blind as to whether the patient is in intervention or control group.
Intervention: Intervention patients will be given a validated home BP monitor and support from the specialist nurse. Control patients will continue with usual care (BP monitoring by their practice).
Main outcome measures in both groups after 12months: 1.Change in systolic BP 2.Cost effectiveness: Incremental cost of the intervention to the NHS and incremental cost per quality adjusted life year gained.
Study hypothesis. Home blood pressure monitoring with nurse support wil lead to lower blood pressure after 12 months compared with usual GP care
详细描述
High blood pressure in patients with stroke increases the risk of recurrence but management in the community is often inadequate. Home blood pressure monitoring may increase patients' involvement in their care, increase compliance, and reduce the need for patients to attend their GP if blood pressure is adequately controlled. However the value of home monitoring to improve BP control is unclear and there is now a window of opportunity for evaluation before their use becomes widespread in the UK. Furthermore its use in stroke patients presents unique challenges relating to the consequent neurological disability.
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
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stroke or TIA in last 9 months
- •Blood pressure above 140/85 when measured more than 1 week after stroke or on anti hypertensive medication
排除标准
- •Severe illness likely to dominate pattern of care
- •Already using home blood pressure monitor
- •Non-English speaking
- •Severe cognitive impairment (AMTS<7)
- •Known secondary hypertension
结局指标
主要结局
Reduction in systolic blood pressure taken by study team at home visit
时间窗: 12 months
次要结局
- Reduction in diastolic blood pressure taken by study team at home visit(12 months)
- Reduction in SBP and DBP taken by study team at home visit(6 months)
- Number of prescribed anti hypertensive medications Number of changes to anti hypertensive medication(12 months)
- EQ-5D(12 months)
- FEAR(12 months)
- Incremental cost of the intervention to the NHS and cost per QALY(12 months)