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基于网络的计算机定制程序改善 2 型糖尿病患者治疗依从性的随机对照试验。

A Web-Based Computer-Tailored Program to Improve Treatment Adherence in Patients With Type 2 Diabetes: Randomized Controlled Trial.

机构信息

Department of Health Promotion, Maastricht University, Maastricht, Netherlands.

Department of Methodology and Statistics, Maastricht University, Maastricht, Netherlands.

出版信息

J Med Internet Res. 2021 Feb 23;23(2):e18524. doi: 10.2196/18524.

Abstract

BACKGROUND

Adherence to core type 2 diabetes mellitus (T2DM) treatment behaviors is suboptimal, and nonadherence is generally not limited to one treatment behavior. The internet holds promise for programs that aim to improve adherence. We developed a computer-tailored eHealth program for patients with T2DM to improve their treatment adherence, that is, adherence to both a healthy lifestyle and medical behaviors.

OBJECTIVE

The objective of this study is to examine the effectiveness of the eHealth program in a randomized controlled trial.

METHODS

Patients with T2DM were recruited by their health professionals and randomized into either the intervention group, that is, access to the eHealth program for 6 months, or a waiting-list control group. In total, 478 participants completed the baseline questionnaire, of which 234 gained access to the eHealth program. Of the 478 participants, 323 were male and 155 were female, the mean age was 60 years, and the participants had unfavorable BMI and HbA levels on average. Outcome data were collected through web-based assessments on physical activity (PA) levels, caloric intake from unhealthy snacks, and adherence to oral hypoglycemic agents (OHAs) and insulin therapy. Changes to separate behaviors were standardized and summed into a composite change score representing changes in the overall treatment adherence. Further standardization of this composite change score yielded the primary outcome, which can be interpreted as Cohen d (effect size). Standardized change scores observed in separate behaviors acted as secondary outcomes. Mixed linear regression analyses were conducted to examine the effectiveness of the intervention on overall and separate treatment behavior adherence, accommodating relevant covariates and patient nesting.

RESULTS

After the 6-month follow-up assessment, 47.4% (111/234) of participants in the intervention group and 72.5% (177/244) of participants in the control group were retained. The overall treatment adherence improved significantly in the intervention group compared with the control group, reflected by a small effect size (d=0.27; 95% CI 0.032 to 0.509; P=.03). When considering changes in separate treatment behaviors, a significant decrease was observed only in caloric intake from unhealthy snacks in comparison with the control group (d=0.36; 95% CI 0.136 to 0.584; P=.002). For adherence to PA (d=-0.14; 95% CI -0.388 to 0.109; P=.27), OHAs (d=0.27; 95% CI -0.027 to 0.457; P=.08), and insulin therapy (d=0.35; 95% CI -0.066 to 0.773; P=.10), no significant changes were observed. These results from the unadjusted analyses were comparable with the results of the adjusted analyses, the per-protocol analyses, and the sensitivity analyses.

CONCLUSIONS

Our multibehavior program significantly improved the overall treatment adherence compared with the control group. To further enhance the impact of the intervention in the personal, societal, and economic areas, a wide-scale implementation of our eHealth intervention is suggested.

TRIAL REGISTRATION

Netherlands Trial Register NL664; https://www.trialregister.nl/trial/6664.

摘要

背景

2 型糖尿病(T2DM)的核心治疗行为的依从性并不理想,而且不依从通常不限于一种治疗行为。互联网为旨在提高依从性的项目提供了希望。我们为 T2DM 患者开发了一个计算机定制的电子健康计划,以提高他们的治疗依从性,即同时遵守健康的生活方式和医疗行为。

目的

本研究的目的是在随机对照试验中检验电子健康计划的有效性。

方法

通过他们的健康专业人员招募 T2DM 患者,并将他们随机分为干预组(即访问电子健康计划 6 个月)或候补名单对照组。共有 478 名参与者完成了基线问卷,其中 234 名参与者获得了电子健康计划的访问权限。在 478 名参与者中,有 323 名男性和 155 名女性,平均年龄为 60 岁,参与者的 BMI 和 HbA 水平平均不利。通过基于网络的评估收集身体活动(PA)水平、不健康零食的卡路里摄入量以及口服降糖药(OHA)和胰岛素治疗的依从性数据。对单独行为的变化进行标准化,并将其汇总为代表整体治疗依从性变化的综合变化分数。对该综合变化分数的进一步标准化产生了主要结果,可解释为 Cohen d(效应大小)。观察到的单独行为的标准化变化分数作为次要结果。混合线性回归分析用于检验干预对整体和单独治疗行为依从性的有效性,考虑到相关协变量和患者嵌套。

结果

在 6 个月的随访评估后,干预组中有 47.4%(111/234)的参与者和对照组中有 72.5%(177/244)的参与者保留下来。与对照组相比,干预组的整体治疗依从性显著改善,反映出较小的效应大小(d=0.27;95%CI 0.032 至 0.509;P=.03)。当考虑单独治疗行为的变化时,与对照组相比,仅观察到不健康零食的卡路里摄入量显著减少(d=0.36;95%CI 0.136 至 0.584;P=.002)。对于 PA 依从性(d=-0.14;95%CI -0.388 至 0.109;P=.27)、OHA(d=0.27;95%CI -0.027 至 0.457;P=.08)和胰岛素治疗(d=0.35;95%CI -0.066 至 0.773;P=.10),未观察到显著变化。这些未调整分析的结果与调整分析、方案分析和敏感性分析的结果相当。

结论

与对照组相比,我们的多行为计划显著提高了整体治疗依从性。为了在个人、社会和经济领域进一步增强干预的影响,建议广泛实施我们的电子健康干预措施。

试验注册

荷兰试验注册 NL664;https://www.trialregister.nl/trial/6664。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/007a/7943340/88630161eddc/jmir_v23i2e18524_fig1.jpg

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