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迈向爱尔兰针对中风/短暂性脑缺血发作的综合血压自我监测解决方案:TASMIN5S IRL随机对照试验的混合方法可行性研究。

Towards an integrated blood pressure self-monitoring solution for stroke/TIA in Ireland: a mixed methods feasibility study for the TASMIN5S IRL randomised controlled trial.

作者信息

Doogue R, Hayes P, Hebert R, Sheikhi A, Rai T, Morton K, Roman C, McManus R J, Glynn L G

机构信息

School of Medicine, University of Limerick, Limerick, Ireland.

Health Research Institute, University of Limerick, Limerick, Ireland.

出版信息

Pilot Feasibility Stud. 2023 Jan 13;9(1):9. doi: 10.1186/s40814-023-01240-2.

Abstract

BACKGROUND

Optimising blood pressure (BP) control is one of the most important modifiable risk factors in preventing subsequent stroke where the risk increases by one-third for every 10 mmHg rise in systolic BP. This study evaluated the feasibility and potential effectiveness of blood pressure self-monitoring with planned medication titration, to inform a definitive trial of the intervention, in patients with a previous stroke or transient ischaemic attack (TIA).

METHODS

Patients with a history of stroke/TIA and sub-optimal BP control were invited to take part in a mixed methods feasibility study for a randomised controlled trial. Those meeting the inclusion criteria with systolic BP >130 mmHg were randomised to a self-monitoring intervention group or usual care group. The intervention involved self-monitoring BP twice a day for 3 days within a 7-day period, every month, following text message reminders. Treatment escalation, based on a pre-agreed plan by the general practitioner (GP) and patient, was initiated according to the results of these readings. Semi-structured interviews were carried out with patients and clinicians and analysed thematically.

RESULTS

Of those identified, 47% (32/68) attended for assessment. Of those assessed, 15 were eligible for recruitment and were consented and randomised to the intervention or control group on a 2:1 basis. Of those randomised, 93% (14/15) completed the study and there were no adverse events. Systolic BP was lower in the intervention group at 3 months. Participants found the intervention acceptable and easy to use. GPs found it easy to incorporate into their practice activity without increasing workload.

CONCLUSIONS

TASMIN5S, an integrated blood pressure self-monitoring intervention in patients with a previous stroke/TIA, is feasible and safe to deliver in primary care. A pre-agreed three-step medication titration plan was easily implemented, increased patient involvement in their care, and had no adverse effects. This feasibility study provides important information to inform a definitive trial to determine the potential effectiveness of the intervention in patients post-stroke or TIA.

TRIAL REGISTRATION

ISRCTN57946500 . Registered on 12/08/2019.

摘要

背景

优化血压控制是预防后续中风最重要的可改变风险因素之一,收缩压每升高10 mmHg,风险增加三分之一。本研究评估了血压自我监测与计划用药滴定法的可行性和潜在效果,以便为一项针对既往有中风或短暂性脑缺血发作(TIA)患者的干预性确定性试验提供依据。

方法

邀请有中风/TIA病史且血压控制欠佳的患者参加一项随机对照试验的混合方法可行性研究。收缩压>130 mmHg且符合纳入标准的患者被随机分为自我监测干预组或常规护理组。干预措施包括每月在7天内,每天自我监测血压两次,持续3天,并接收短信提醒。根据全科医生(GP)和患者预先商定的计划,根据这些读数的结果启动治疗升级。对患者和临床医生进行了半结构化访谈,并进行了主题分析。

结果

在被识别的患者中,47%(32/68)参加了评估。在接受评估的患者中,15人符合招募条件,并同意按2:1的比例随机分为干预组或对照组。在随机分组的患者中,93%(14/15)完成了研究,且无不良事件发生。干预组在3个月时收缩压较低。参与者认为该干预措施可以接受且易于使用。全科医生发现该措施易于纳入其诊疗活动,且不会增加工作量。

结论

TASMIN5S,一项针对既往有中风/TIA患者的综合血压自我监测干预措施,在初级保健中实施是可行且安全的。预先商定的三步用药滴定计划易于实施,增加了患者对自身护理情况的参与度,且无不良影响。这项可行性研究提供了重要信息,为一项确定性试验提供依据,以确定该干预措施对中风或TIA后患者的潜在效果。

试验注册

ISRCTN57946500。于2019年8月12日注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1a10/9837979/2692cc8892c3/40814_2023_1240_Fig1_HTML.jpg

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