McManus R J, Smith A, Temple E, Yu L M, Allen J, Doogue R, Ford G A, Glynn L, Guthrie B, Hall P, Hinton L, Hobbs F D R, Mant J, McKinstry B, Mead G, Morton K, Rai T, Rice C, Roman C, Stoddart A, Tarassenko L, Velardo C, Williams M, Yardley L
Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
Brighton and Sussex Medical School, Universities of Brighton and Sussex, Brighton, UK.
BMC Cardiovasc Disord. 2024 Dec 27;24(1):746. doi: 10.1186/s12872-024-04320-0.
Blood pressure (BP) control following stroke is important but currently sub-optimal. This trial aimed to determine whether self-monitoring of hypertension with telemonitoring and a treatment escalation protocol, results in lower BP than usual care in people with previous stroke or transient ischaemic attack (TIA).
Unblinded randomised controlled trial, comparing a BP telemonitoring-based intervention with control (usual care) for hypertension management in 12 primary care practices in England. People with previous stroke or TIA with clinic systolic BP 130-180 mmHg, taking ≤ 3 antihypertensive medications and on stable treatment for at least four weeks were randomised 1:1 using secure online system to intervention or control. The BP:Together intervention comprised self-monitoring of blood pressure with a digital behavioural intervention which supported telemonitoring of self-monitored BP with feedback to clinicians and patients regarding medication titration. The planned primary outcome was difference in clinic measured systolic BP 12 months from randomisation but was not available following early study termination due to withdrawal of funding during the COVID-19 pandemic. Instead, in addition to pre-randomised data, routinely recorded BP was extracted from electronic patient records both pre- and post-randomisation and presented descriptively only. An intention to treat approach was taken.
From 650 postal invitations, 129 (20%) responded, of whom 95 people had been screened for eligibility prior to the pandemic (November 2019-March 2020) and 55 (58%) were randomised. Pre-randomisation routinely recorded mean BP was 145/78 mmHg in the control (n = 26) and 145/79 mmHg in the self-monitoring (n = 21) groups. Post-randomisation mean BP was 134/73 mmHg in the control (n = 19) and 130/75 mmHg in the self-monitoring (n = 25) groups. Participants randomised to self-monitoring used the intervention for ≥ 7 months in 25/27 (93%) of cases.
Recruitment of people with stroke/TIA to a trial comparing a BP self-monitoring and digital behavioural intervention to usual care was feasible prior to the COVID-19 pandemic and the vast majority of those randomised to intervention used it while the trial was running. Routinely recorded blood pressure control improved in both groups. Digital interventions including self-monitoring are feasible for people with stroke/TIA and should be definitively evaluated in future trials.
ISRCTN57946500 06/09/2019 Prospective.
中风后血压控制很重要，但目前并不理想。本试验旨在确定，对于既往有中风或短暂性脑缺血发作（TIA）的患者，采用远程监测和治疗升级方案进行高血压自我监测，是否能使血压低于常规治疗。
非盲随机对照试验，在英国的12家基层医疗诊所比较基于血压远程监测的干预措施与对照（常规治疗）对高血压的管理效果。既往有中风或TIA且诊所收缩压为130 - 180 mmHg、服用≤3种抗高血压药物且稳定治疗至少四周的患者，使用安全在线系统按1:1随机分为干预组或对照组。BP:Together干预措施包括使用数字行为干预进行血压自我监测，该干预支持对自我监测的血压进行远程监测，并向临床医生和患者反馈药物滴定情况。计划的主要结局是随机分组后12个月诊所测量的收缩压差异，但由于在COVID - 19大流行期间资金撤回，早期研究提前终止，该数据未可得。取而代之的是，除了随机分组前的数据外，还从电子病历中提取了随机分组前后常规记录的血压，并仅进行描述性呈现。采用意向性分析方法。
在650份邮寄邀请函中，129人（20%）回复，其中95人在大流行前（2019年11月 - 2020年3月）接受了资格筛查，55人（58%）被随机分组。随机分组前，对照组（n = 26）常规记录的平均血压为145/78 mmHg，自我监测组（n = 21）为145/79 mmHg。随机分组后，对照组（n = 19）平均血压为134/73 mmHg，自我监测组（n = 25）为130/75 mmHg。随机分配到自我监测组的参与者在25/27（93%）的病例中使用该干预措施≥7个月。
在COVID - 19大流行之前，招募中风/TIA患者参加一项比较血压自我监测和数字行为干预与常规治疗的试验是可行的，并且绝大多数随机分配到干预组的患者在试验进行期间使用了该干预措施。两组的常规记录血压控制均有所改善。包括自我监测在内的数字干预措施对中风/TIA患者是可行的，应在未来试验中进行明确评估。
ISRCTN57946500 2019年9月6日 前瞻性。
