Deep Medicine, Oxford Martin School, University of Oxford, Oxford, United Kingdom
Nuffield Department of Women's and Reproductive Health, Medical Science Division, University of Oxford, Oxford, United Kingdom.
Heart. 2020 Oct;106(20):1573-1578. doi: 10.1136/heartjnl-2020-316773. Epub 2020 Jun 24.
We aimed to investigate whether digital home monitoring with centralised specialist support for remote management of heart failure (HF) is more effective in improving medical therapy and patients' quality of life than digital home monitoring alone.
In a two-armed partially blinded parallel randomised controlled trial, seven sites in the UK recruited a total of 202 high-risk patients with HF (71.3 years SD 11.1; left ventricular ejection fraction 32.9% SD 15.4). Participants in both study arms were given a tablet computer, Bluetooth-enabled blood pressure monitor and weighing scales for health monitoring. Participants randomised to intervention received additional regular feedback to support self-management and their primary care doctors received instructions on blood investigations and pharmacological treatment. The primary outcome was the use of guideline-recommended medical therapy for chronic HF and major comorbidities, measured as a composite opportunity score (total number of recommended treatment given divided by the total number of opportunities the treatment should have been given, with a score 1 indicating 100% adherence to recommendations). Co-primary outcome was change in physical score of Minnesota Living with Heart Failure questionnaire.
101 patients were randomised to 'enhanced self-management' and 101 to 'supported medical management'. At the end of follow-up, the opportunity score was 0.54 (95% CI 0.46 to 0.62) in the control arm and 0.61 (95% CI 0.52 to 0.70) in the intervention arm (p=0.25). Physical well-being of participants also did not differ significantly between the groups (17.4 (12.4) mean (SD) for control arm vs 16.5 (12.1) in treatment arm; p for change=0.84).
Central provision of tailored specialist management in a multi-morbid HF population was feasible. However, there was no strong evidence for improvement in use of evidence-based treatment nor health-related quality of life.
ISRCTN86212709.
我们旨在探究与单纯的家庭数字化监测相比，在远程管理心力衰竭（HF）中加入中央专家支持的数字化家庭监测，是否能更有效地改善患者的药物治疗和生活质量。
在一项双臂、部分设盲、平行的随机对照试验中，英国的 7 个研究点共招募了 202 名高危 HF 患者（71.3 岁，标准差 11.1；左心室射血分数 32.9%，标准差 15.4）。两组研究参与者均配备了平板电脑、支持蓝牙的血压监测仪和体重秤，以进行健康监测。被随机分配到干预组的参与者还会收到额外的定期反馈，以支持自我管理，而他们的初级保健医生则会收到有关血液检查和药物治疗的指导。主要结局是慢性 HF 和主要合并症的指南推荐药物治疗的使用情况，通过复合机会评分（建议的治疗总数除以应给予治疗的总数，得分 1 表示对建议的治疗方案的依从率为 100%）进行测量。共同主要结局是明尼苏达州心力衰竭生活质量问卷的身体评分变化。
101 名患者被随机分配到“增强自我管理”组，101 名患者被分配到“支持性医疗管理”组。在随访结束时，对照组的机会评分是 0.54（95%置信区间 0.46 至 0.62），干预组是 0.61（95%置信区间 0.52 至 0.70）（p=0.25）。两组参与者的身体舒适度也没有显著差异（对照组为 17.4（12.4），治疗组为 16.5（12.1）；治疗变化的 p 值=0.84）。
在多合并症 HF 人群中提供量身定制的专科管理是可行的。然而，在改善基于证据的治疗方法的使用和改善健康相关生活质量方面，没有强有力的证据。
ISRCTN86212709。
