{"title":"数字化生活方式干预对高血压患者的影响：随机对照试验的结果","authors":"Alina Wildenauer MA, Leonie Franziska Maurer PhD, Laurin Rötzer MD, Torsten Eggert PhD, Christoph Schöbel MD","doi":"10.1111/jch.14811","DOIUrl":null,"url":null,"abstract":"<p>In this pilot study, the authors investigated the preliminary effectiveness of the digital lifestyle intervention, actensio (mementor DE GmbH), in treating arterial hypertension. Adults with arterial hypertension were randomly assigned to an intervention group (actensio + standard care) or a control group (waiting list + standard care) in a 1:1 ratio. Primary and secondary endpoints were assessed at baseline (t0) and 3 months post-randomization (t1). The primary endpoint was average systolic blood pressure, measured at home for 1 week. Secondary endpoints included patient engagement (measured using the “patient activation measure”; PAM-13), average diastolic blood pressure, and heart rate. All endpoints were analyzed using ANCOVA models, following an intention-to-treat approach, while adjusting for baseline values. Missing data were estimated using multiple imputation models. A total of <i>N</i> = 102 participants (f = 59, age = 52.94 ± 9.01) were randomized to either the intervention (IG; <i>N</i> = 52) or the control group (CG; <i>N</i> = 50), of which <i>N</i> = 80 completed the blood pressure diary, and <i>N</i> = 81 the PAM-13 at t1. Between-group comparisons showed an average group difference in systolic blood pressure of −5.06 mm Hg (95% CI = −8.71 to −1.41, <i>p </i>= .013) between the intervention group (M = 137.37 ± 10.13) and the control group (M = 142.35 ± 11.23). Average group difference for patient engagement was 3.35 points with a trend towards statistical significance (95% CI = −018 to 6.89, <i>p </i>= .064), favoring the intervention group (M<sub>IG </sub>= 79.38 ± 9.44 vs. M<sub>CG </sub>= 75.45 ± 10.62). There were no group differences in diastolic blood pressure (−1.78 mm Hg; 95% CI = −4.50 to 0.95, <i>p = </i>.402) and heart rate (−0.684; 95% CI = −3.73 to 2.36, <i>p</i> = 0.683). The results of the present pilot study confirm the preliminary effectiveness of the digital lifestyle intervention, actensio, in reducing high blood pressure in patients with hypertension.</p>","PeriodicalId":50237,"journal":{"name":"Journal of Clinical Hypertension","volume":null,"pages":null},"PeriodicalIF":2.7000,"publicationDate":"2024-07-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11301437/pdf/","citationCount":"0","resultStr":"{\"title\":\"The effects of a digital lifestyle intervention in patients with hypertension: Results of a pilot randomized controlled trial\",\"authors\":\"Alina Wildenauer MA, Leonie Franziska Maurer PhD, Laurin Rötzer MD, Torsten Eggert PhD, Christoph Schöbel MD\",\"doi\":\"10.1111/jch.14811\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p>In this pilot study, the authors investigated the preliminary effectiveness of the digital lifestyle intervention, actensio (mementor DE GmbH), in treating arterial hypertension. Adults with arterial hypertension were randomly assigned to an intervention group (actensio + standard care) or a control group (waiting list + standard care) in a 1:1 ratio. Primary and secondary endpoints were assessed at baseline (t0) and 3 months post-randomization (t1). The primary endpoint was average systolic blood pressure, measured at home for 1 week. Secondary endpoints included patient engagement (measured using the “patient activation measure”; PAM-13), average diastolic blood pressure, and heart rate. All endpoints were analyzed using ANCOVA models, following an intention-to-treat approach, while adjusting for baseline values. Missing data were estimated using multiple imputation models. A total of <i>N</i> = 102 participants (f = 59, age = 52.94 ± 9.01) were randomized to either the intervention (IG; <i>N</i> = 52) or the control group (CG; <i>N</i> = 50), of which <i>N</i> = 80 completed the blood pressure diary, and <i>N</i> = 81 the PAM-13 at t1. Between-group comparisons showed an average group difference in systolic blood pressure of −5.06 mm Hg (95% CI = −8.71 to −1.41, <i>p </i>= .013) between the intervention group (M = 137.37 ± 10.13) and the control group (M = 142.35 ± 11.23). Average group difference for patient engagement was 3.35 points with a trend towards statistical significance (95% CI = −018 to 6.89, <i>p </i>= .064), favoring the intervention group (M<sub>IG </sub>= 79.38 ± 9.44 vs. M<sub>CG </sub>= 75.45 ± 10.62). There were no group differences in diastolic blood pressure (−1.78 mm Hg; 95% CI = −4.50 to 0.95, <i>p = </i>.402) and heart rate (−0.684; 95% CI = −3.73 to 2.36, <i>p</i> = 0.683). The results of the present pilot study confirm the preliminary effectiveness of the digital lifestyle intervention, actensio, in reducing high blood pressure in patients with hypertension.</p>\",\"PeriodicalId\":50237,\"journal\":{\"name\":\"Journal of Clinical Hypertension\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":2.7000,\"publicationDate\":\"2024-07-11\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11301437/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Clinical Hypertension\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://onlinelibrary.wiley.com/doi/10.1111/jch.14811\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"PERIPHERAL VASCULAR DISEASE\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Clinical Hypertension","FirstCategoryId":"3","ListUrlMain":"https://onlinelibrary.wiley.com/doi/10.1111/jch.14811","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"PERIPHERAL VASCULAR DISEASE","Score":null,"Total":0}
引用次数: 0
摘要
在这项试点研究中，作者调查了数字化生活方式干预措施 actensio（mementor DE GmbH）治疗动脉高血压的初步效果。患有动脉高血压的成年人按 1:1 的比例被随机分配到干预组（actensio + 标准治疗）或对照组（候补名单 + 标准治疗）。主要和次要终点分别在基线（t0）和随机分配后 3 个月（t1）进行评估。主要终点是平均收缩压，在家测量一周。次要终点包括患者参与度（使用 "患者激活测量"；PAM-13）、平均舒张压和心率。所有终点均采用方差分析模型进行分析，采用意向治疗方法，同时对基线值进行调整。缺失数据采用多重估算模型进行估算。共有 N = 102 名参与者（f = 59，年龄 = 52.94 ± 9.01）被随机分配到干预组（IG；N = 52）或对照组（CG；N = 50），其中 N = 80 人在 t1 完成了血压日记，N = 81 人完成了 PAM-13 测试。组间比较显示，干预组（M = 137.37 ± 10.13）和对照组（M = 142.35 ± 11.23）的收缩压平均组间差异为-5.06 mm Hg (95% CI = -8.71 to -1.41, p = .013)。患者参与度的平均组间差异为 3.35 分，有统计学显著性趋势（95% CI = -018 至 6.89，p = .064），干预组更有利（MIG = 79.38 ± 9.44 vs. MCG = 75.45 ± 10.62）。舒张压（-1.78 mm Hg; 95% CI = -4.50 to 0.95, p = .402）和心率（-0.684; 95% CI = -3.73 to 2.36, p = 0.683）没有组间差异。本试点研究的结果证实了数字化生活方式干预措施 Actensio 在降低高血压患者高血压方面的初步效果。
The effects of a digital lifestyle intervention in patients with hypertension: Results of a pilot randomized controlled trial
In this pilot study, the authors investigated the preliminary effectiveness of the digital lifestyle intervention, actensio (mementor DE GmbH), in treating arterial hypertension. Adults with arterial hypertension were randomly assigned to an intervention group (actensio + standard care) or a control group (waiting list + standard care) in a 1:1 ratio. Primary and secondary endpoints were assessed at baseline (t0) and 3 months post-randomization (t1). The primary endpoint was average systolic blood pressure, measured at home for 1 week. Secondary endpoints included patient engagement (measured using the “patient activation measure”; PAM-13), average diastolic blood pressure, and heart rate. All endpoints were analyzed using ANCOVA models, following an intention-to-treat approach, while adjusting for baseline values. Missing data were estimated using multiple imputation models. A total of N = 102 participants (f = 59, age = 52.94 ± 9.01) were randomized to either the intervention (IG; N = 52) or the control group (CG; N = 50), of which N = 80 completed the blood pressure diary, and N = 81 the PAM-13 at t1. Between-group comparisons showed an average group difference in systolic blood pressure of −5.06 mm Hg (95% CI = −8.71 to −1.41, p = .013) between the intervention group (M = 137.37 ± 10.13) and the control group (M = 142.35 ± 11.23). Average group difference for patient engagement was 3.35 points with a trend towards statistical significance (95% CI = −018 to 6.89, p = .064), favoring the intervention group (MIG = 79.38 ± 9.44 vs. MCG = 75.45 ± 10.62). There were no group differences in diastolic blood pressure (−1.78 mm Hg; 95% CI = −4.50 to 0.95, p = .402) and heart rate (−0.684; 95% CI = −3.73 to 2.36, p = 0.683). The results of the present pilot study confirm the preliminary effectiveness of the digital lifestyle intervention, actensio, in reducing high blood pressure in patients with hypertension.
期刊介绍：
The Journal of Clinical Hypertension is a peer-reviewed, monthly publication that serves internists, cardiologists, nephrologists, endocrinologists, hypertension specialists, primary care practitioners, pharmacists and all professionals interested in hypertension by providing objective, up-to-date information and practical recommendations on the full range of clinical aspects of hypertension. Commentaries and columns by experts in the field provide further insights into our original research articles as well as on major articles published elsewhere. Major guidelines for the management of hypertension are also an important feature of the Journal. Through its partnership with the World Hypertension League, JCH will include a new focus on hypertension and public health, including major policy issues, that features research and reviews related to disease characteristics and management at the population level.
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