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12个月移动健康家庭远程监测对老年高血压和2型糖尿病患者临床结局的影响:多中心随机对照试验

Impact of 12-Month mHealth Home Telemonitoring on Clinical Outcomes in Older Individuals With Hypertension and Type 2 Diabetes: Multicenter Randomized Controlled Trial.

作者信息

Mihevc Matic, Mori Lukančič Majda, Zavrnik Črt, Virtič Potočnik Tina, Ružić Gorenjec Nina, Petek Šter Marija, Klemenc-Ketiš Zalika, Poplas Susič Antonija

机构信息

Department of Family Medicine, Medical Faculty University of Ljubljana, Ljubljana, Slovenia.

Primary Healthcare Research and Development Institute, Community Health Centre Ljubljana, Metelkova ulica 9, Ljubljana, 1000, Slovenia, 386 40520247.

出版信息

JMIR Mhealth Uhealth. 2025 May 29;13:e59733. doi: 10.2196/59733.

DOI:10.2196/59733
PMID:40440692
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12140507/
Abstract

BACKGROUND

As the population ages, the prevalence of chronic diseases such as arterial hypertension (AH) and type 2 diabetes (T2D) is increasing, posing challenges for effective management in primary care settings. Although mobile health (mHealth) home telemonitoring offers promising support, evidence regarding its clinical impact on older patients is limited.

OBJECTIVE

The objective of this paper was to evaluate the impact of 12-month telemonitoring on clinical outcomes in older individuals with AH and T2D compared to standard care in a primary care setting.

METHODS

In a multicenter, open-label, randomized controlled trial, individuals aged 65 years and older with AH and T2D were randomly assigned in a 1:1 ratio to either a telemonitoring group or a standard care group. The telemonitoring group received mHealth support in addition to standard care. Over 12 months, participants measured blood pressure (BP) twice weekly with 2 consecutive readings each morning and evening, using the second reading as valid. Blood glucose (BG) was measured monthly, both fasting and 90 minutes after meals. Abnormal results triggered a 7-day BP or 1-day BG profile or a teleconsultation with a general practitioner. Meanwhile, the control group received routine care based on integrated care protocols at community health centers. Primary outcomes were the differences between groups in the change in systolic blood pressure (SBP) and HbA1c levels at 12 months after inclusion from baseline. Secondary outcomes included changes in diastolic blood pressure, fasting BG, lipid profile, body mass index, appraisal of diabetes, and behavioral risk factors.

RESULTS

Initially, 128 patients were enrolled, with 117 (91.4%) completing the 12-month follow-up. The mean age was 71.3 (SD 4.7) years, with a mean SBP of 136.7 (SD 14.1) mmHg and mean HbA1c of 7.2% (SD 1.0%). There were no significant sociodemographic or clinical differences between groups at baseline. At 12 months, the telemonitoring group experienced significant reductions in SBP (-9.7 mmHg, 95% CI -12.6 to -6.8; P<.001) and HbA1c (-0.5%, 95% CI -0.8 to -0.3; P<.001), whereas the control group exhibited nonsignificant changes in SBP (-2.8 mmHg, 95% CI -5.9 to 0.2; P=.07) and HbA1c (0%, 95% CI -0.3 to 1.9; P=.75). The difference between groups at 12 months was significant for both SBP (-6.9 mmHg, 95% CI -11 to -2.7; P=.001) and HbA1c (-0.5%, 95% CI -0.8 to -0.2; P=.002), with no significant differences observed in secondary outcomes.

CONCLUSIONS

Telemonitoring effectively improves AH and T2D control in older people but has no impact on other cardiovascular risk factors and diabetes-related quality of life. Future research should explore combining educational and behavioral interventions with telemonitoring to enhance overall health outcomes. However, complex interventions may pose challenges for the elderly, suggesting the need for careful patient selection to ensure that benefits outweigh potential burdens.

摘要

背景

随着人口老龄化,动脉高血压(AH)和2型糖尿病(T2D)等慢性病的患病率不断上升,给基层医疗环境中的有效管理带来了挑战。尽管移动健康(mHealth)家庭远程监测提供了有前景的支持,但关于其对老年患者临床影响的证据有限。

目的

本文的目的是评估在基层医疗环境中,与标准护理相比,为期12个月的远程监测对患有AH和T2D的老年人临床结局的影响。

方法

在一项多中心、开放标签、随机对照试验中,65岁及以上患有AH和T2D的个体按1:1的比例随机分配到远程监测组或标准护理组。远程监测组除接受标准护理外,还获得mHealth支持。在12个月期间,参与者每周测量两次血压(BP),每天早晚各连续测量两次,以第二次测量结果为准。每月测量血糖(BG),包括空腹血糖和餐后90分钟血糖。异常结果会触发7天的血压或1天的血糖记录,或与全科医生进行远程会诊。同时,对照组在社区卫生中心接受基于综合护理方案的常规护理。主要结局是入组后12个月时收缩压(SBP)和糖化血红蛋白(HbA1c)水平变化的组间差异。次要结局包括舒张压、空腹血糖、血脂谱、体重指数、糖尿病评估和行为危险因素的变化。

结果

最初招募了128名患者,其中117名(91.4%)完成了12个月的随访。平均年龄为71.3(标准差4.7)岁,平均SBP为136.7(标准差14.1)mmHg,平均HbA1c为7.2%(标准差1.0%)。两组在基线时的社会人口统计学或临床特征无显著差异。在12个月时,远程监测组的SBP显著降低(-9.7 mmHg,95%置信区间-12.6至-6.8;P<0.001),HbA1c也显著降低(-0.5%,95%置信区间-0.8至-0.3;P<0.001),而对照组的SBP变化不显著(-2.8 mmHg,95%置信区间-5.9至0.2;P=0.07),HbA1c变化也不显著(0%,95%置信区间-0.3至1.9;P=0.75)。12个月时两组在SBP(-6.9 mmHg,95%置信区间-11至-2.7;P=0.001)和HbA1c(-0.5%,95%置信区间-0.8至-0.2;P=0.002)方面的差异均有统计学意义,次要结局方面未观察到显著差异。

结论

远程监测可有效改善老年人的AH和T2D控制,但对其他心血管危险因素和糖尿病相关生活质量无影响。未来研究应探索将教育和行为干预与远程监测相结合,以改善整体健康结局。然而,复杂的干预措施可能给老年人带来挑战,这表明需要谨慎选择患者,以确保获益大于潜在负担。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b4b2/12140507/a0b577b4f81e/mhealth-v13-e59733-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b4b2/12140507/9f0c8e460c9e/mhealth-v13-e59733-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b4b2/12140507/a0b577b4f81e/mhealth-v13-e59733-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b4b2/12140507/9f0c8e460c9e/mhealth-v13-e59733-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b4b2/12140507/a0b577b4f81e/mhealth-v13-e59733-g002.jpg

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Managing cardiovascular risk factors with telemedicine in primary care: A systematic review and meta-analysis of patients with arterial hypertension and type 2 diabetes.基层医疗中通过远程医疗管理心血管危险因素:对动脉高血压和2型糖尿病患者的系统评价与荟萃分析
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Beyond diagnosis: Investigating factors influencing health-related quality of life in older people with type 2 diabetes in Slovenia.超越诊断:探究斯洛文尼亚老年 2 型糖尿病患者健康相关生活质量的影响因素。
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