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移动医疗干预在 2 型糖尿病患者中的应用:一项随机临床试验。

Mobile Health Intervention in Patients With Type 2 Diabetes: A Randomized Clinical Trial.

机构信息

Department of Population and Quantitative Health Sciences, University of Massachusetts Chan Medical School, Worcester.

Department of Medicine, College of Medicine, University of Illinois Chicago, Chicago.

出版信息

JAMA Netw Open. 2023 Sep 5;6(9):e2333629. doi: 10.1001/jamanetworkopen.2023.33629.

DOI:10.1001/jamanetworkopen.2023.33629
PMID:37773498
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10543137/
Abstract

IMPORTANCE

Clinical pharmacists and health coaches using mobile health (mHealth) tools, such as telehealth and text messaging, may improve blood glucose levels in African American and Latinx populations with type 2 diabetes.

OBJECTIVE

To determine whether clinical pharmacists and health coaches using mHealth tools can improve hemoglobin A1c (HbA1c) levels.

DESIGN, SETTING, AND PARTICIPANTS: This randomized clinical trial included 221 African American or Latinx patients with type 2 diabetes and elevated HbA1c (≥8%) from an academic medical center in Chicago. Adult patients aged 21 to 75 years were enrolled and randomized from March 23, 2017, through January 8, 2020. Patients randomized to the intervention group received mHealth diabetes support for 1 year followed by monitored usual diabetes care during a second year (follow-up duration, 24 months). Those randomized to the waiting list control group received usual diabetes care for 1 year followed by the mHealth diabetes intervention during a second year.

INTERVENTIONS

The mHealth diabetes intervention included remote support (eg, review of glucose levels and medication intensification) from clinical pharmacists via a video telehealth platform. Health coach activities (eg, addressing barriers to medication use and assisting pharmacists in medication reconciliation and telehealth) occurred in person at participant homes and via phone calls and text messaging. Usual diabetes care comprised routine health care from patients' primary care physicians, including medication reconciliation and adjustment.

MAIN OUTCOMES AND MEASURES

Outcomes included HbA1c (primary outcome), blood pressure, cholesterol, body mass index, health-related quality of life, diabetes distress, diabetes self-efficacy, depressive symptoms, social support, medication-taking behavior, and diabetes self-care measured every 6 months.

RESULTS

Among the 221 participants (mean [SD] age, 55.2 [9.5] years; 154 women [69.7%], 148 African American adults [67.0%], and 73 Latinx adults [33.0%]), the baseline mean (SD) HbA1c level was 9.23% (1.53%). Over the initial 12 months, HbA1c improved by a mean of -0.79 percentage points in the intervention group compared with -0.24 percentage points in the waiting list control group (treatment effect, -0.62; 95% CI, -1.04 to -0.19; P = .005). Over the subsequent 12 months, a significant change in HbA1c was observed in the waiting list control group after they received the same intervention (mean change, -0.57 percentage points; P = .002), while the intervention group maintained benefit (mean change, 0.17 percentage points; P = .35). No between-group differences were found in adjusted models for secondary outcomes.

CONCLUSIONS AND RELEVANCE

In this randomized clinical trial, HbA1c levels improved among African American and Latinx adults with type 2 diabetes. These findings suggest that a clinical pharmacist and health coach-delivered mobile health intervention can improve blood glucose levels in African American and Latinx populations and may help reduce racial and ethnic disparities.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT02990299.

摘要

重要性

使用移动医疗 (mHealth) 工具(如远程医疗和短信服务)的临床药师和健康教练可能会改善 2 型糖尿病的非裔美国人和拉丁裔人群的血糖水平。

目的

确定使用 mHealth 工具的临床药师和健康教练是否可以改善糖化血红蛋白 (HbA1c) 水平。

设计、地点和参与者:这是一项随机临床试验,纳入了来自芝加哥一所学术医疗中心的 221 名非裔美国人和拉丁裔 2 型糖尿病且 HbA1c 升高(≥8%)的患者。招募了年龄在 21 至 75 岁之间的成年患者,并于 2017 年 3 月 23 日至 2020 年 1 月 8 日期间进行随机分组。随机分为干预组的患者接受了为期 1 年的 mHealth 糖尿病支持,随后在第二年接受了监测的常规糖尿病护理(随访时间为 24 个月)。随机分配到候补名单对照组的患者接受了为期 1 年的常规糖尿病护理,然后在第二年接受 mHealth 糖尿病干预。

干预措施

mHealth 糖尿病干预包括临床药师通过视频远程医疗平台提供远程支持(例如,血糖水平复查和药物强化)。健康教练的活动(例如,解决药物使用障碍,并协助药师进行药物调整和远程医疗)则在患者家中亲自进行,以及通过电话和短信进行。常规糖尿病护理包括患者的初级保健医生提供的常规医疗保健,包括药物调整。

主要结果和测量指标

结果包括 HbA1c(主要结果)、血压、胆固醇、体重指数、健康相关生活质量、糖尿病困扰、糖尿病自我效能、抑郁症状、社会支持、用药行为和糖尿病自我护理,每 6 个月测量一次。

结果

在 221 名参与者中(平均[标准差]年龄 55.2[9.5]岁;154 名女性[69.7%],148 名非裔美国成年人[67.0%]和 73 名拉丁裔成年人[33.0%]),基线平均(标准差)HbA1c 水平为 9.23%(1.53%)。在最初的 12 个月内,干预组的 HbA1c 平均下降了 0.79 个百分点,而候补名单对照组则下降了 0.24 个百分点(治疗效果,-0.62;95%CI,-1.04 至 -0.19;P = .005)。在随后的 12 个月中,候补名单对照组在接受相同干预后 HbA1c 水平出现了显著变化(平均变化,-0.57 个百分点;P = .002),而干预组则保持了获益(平均变化,0.17 个百分点;P = .35)。在调整后的次要结局模型中,两组之间未发现差异。

结论和相关性

在这项随机临床试验中,2 型糖尿病的非裔美国人和拉丁裔成年人的 HbA1c 水平得到了改善。这些发现表明,临床药师和健康教练提供的移动医疗干预可以改善非裔美国人和拉丁裔人群的血糖水平,并可能有助于减少种族和民族差异。

试验注册

ClinicalTrials.gov 标识符:NCT02990299。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e491/10543137/2f2bf76e4304/jamanetwopen-e2333629-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e491/10543137/91fb96e1c66f/jamanetwopen-e2333629-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e491/10543137/2f2bf76e4304/jamanetwopen-e2333629-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e491/10543137/91fb96e1c66f/jamanetwopen-e2333629-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e491/10543137/2f2bf76e4304/jamanetwopen-e2333629-g002.jpg

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