Home and Online Management and Evaluation of Blood Pressure (HOME BP) digital intervention for self-management of uncontrolled, essential hypertension: a protocol for the randomised controlled HOME BP trial.
Home and Online Management and Evaluation of Blood Pressure (HOME BP) digital intervention for self-management of uncontrolled, essential hypertension: a protocol for the randomised controlled HOME BP trial.
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DOI：
10.1136/bmjopen-2016-012684
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发表时间：
2016-11-07
期刊：
影响因子：
2.9
通讯作者：
McManus RJ
中科院分区：
文献类型：
--
作者：
Band R;Morton K;Stuart B;Raftery J;Bradbury K;Yao GL;Zhu S;Little P;Yardley L;McManus RJ
自我管理高血压，包括自我监测和抗高血压药物滴定，与常规护理相比，1年后血压（BP）降低。当前试验的目的是评估家庭和在线血压管理和评估（Home BP）干预对初级保健中高血压自我管理的有效性。HOME BP试验将是一项随机对照试验，比较血压自我管理（包括HOME BP在线数字干预与自我监测、生活方式建议和降压药物滴定）与对未控制的原发性高血压患者的常规护理。符合条件的患者将从初级保健中招募，随机分配到常规护理组或使用HOME BP进行自我管理组。主要结果将是干预组和对照组在基线血压和协变量调整后12个月随访时的平均收缩压（mm Hg）的差异。次要结局（也根据基线和协变量进行调整）将是6个月时的平均血压和12个月时的舒张血压的差异；病人实施;生活质量和经济分析，包括与干预和相关服务相关的所有关键资源，采用广泛的社会视角，包括NHS，社会护理和患者成本，在试验中考虑并以生命周期为模型。药物信念、依从性和改变；自我效能感;可感知的副作用和生活方式的改变将用于过程分析。定性分析将探讨HOME BP的患者和医疗保健专业经验，以深入了解影响可接受性、可行性和依从性的因素。本研究已获得NHS伦理批准（REC参考15/SC/0082）。HOME BP的研究结果将通过同行评审的出版物、科学会议和研讨会广泛传播。如果成功，HOME BP将直接适用于英国高血压的初级保健管理。ISRCTN13790648;pre-results。
Self-management of hypertension, including self-monitoring and antihypertensive medication titration, lowers blood pressure (BP) at 1 year compared to usual care. The aim of the current trial is to assess the effectiveness of the Home and Online Management and Evaluation of Blood Pressure (HOME BP) intervention for the self-management of hypertension in primary care. The HOME BP trial will be a randomised controlled trial comparing BP self-management—consisting of the HOME BP online digital intervention with self-monitoring, lifestyle advice and antihypertensive drug titration—with usual care for people with uncontrolled essential hypertension. Eligible patients will be recruited from primary care and randomised to usual care or to self-management using HOME BP. The primary outcome will be the difference in mean systolic BP (mm Hg) at 12-month follow-up between the intervention and control groups adjusting for baseline BP and covariates. Secondary outcomes (also adjusted for baseline and covariates where appropriate) will be differences in mean BP at 6 months and diastolic BP at 12 months; patient enablement; quality of life, and economic analyses including all key resources associated with the intervention and related services, adopting a broad societal perspective to include NHS, social care and patient costs, considered within trial and modelled with a lifetime horizon. Medication beliefs, adherence and changes; self-efficacy; perceived side effects and lifestyle changes will be measured for process analyses. Qualitative analyses will explore patient and healthcare professional experiences of HOME BP to gain insights into the factors affecting acceptability, feasibility and adherence. This study has received NHS ethical approval (REC reference 15/SC/0082). The findings from HOME BP will be disseminated widely through peer-reviewed publications, scientific conferences and workshops. If successful, HOME BP will be directly applicable to UK primary care management of hypertension. ISRCTN13790648; pre-results.
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