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在初级保健中实施的用于治疗 2 型糖尿病伴发抑郁症的网络应用的经济学评价:多中心随机对照试验。

Economic Evaluation of a Web Application Implemented in Primary Care for the Treatment of Depression in Patients With Type 2 Diabetes Mellitus: Multicenter Randomized Controlled Trial.

机构信息

Research and Innovation Unit, Costa del Sol University Hospital, Marbella, Spain.

Network for Research on Chronicity, Primary Care, and Health Promotion (RICAPPS), Málaga, Spain.

出版信息

JMIR Mhealth Uhealth. 2024 May 16;12:e55483. doi: 10.2196/55483.

DOI:10.2196/55483
PMID:38754101
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11140277/
Abstract

BACKGROUND

Depressive disorder and type 2 diabetes mellitus (T2DM) are prevalent in primary care (PC). Pharmacological treatment, despite controversy, is commonly chosen due to resource limitations and difficulties in accessing face-to-face interventions. Depression significantly impacts various aspects of a person's life, affecting adherence to medical prescriptions and glycemic control and leading to future complications and increased health care costs. To address these challenges, information and communication technologies (eg, eHealth) have been introduced, showing promise in improving treatment continuity and accessibility. However, while eHealth programs have demonstrated effectiveness in alleviating depressive symptoms, evidence regarding glycemic control remains inconclusive. This randomized controlled trial aimed to test the efficacy of a low-intensity psychological intervention via a web app for mild-moderate depressive symptoms in individuals with T2DM compared with treatment as usual (TAU) in PC.

OBJECTIVE

This study aimed to analyze the cost-effectiveness and cost-utility of a web-based psychological intervention to treat depressive symptomatology in people with T2DM compared with TAU in a PC setting.

METHODS

A multicenter randomized controlled trial was conducted with 49 patients with T2DM, depressive symptoms of moderate severity, and glycosylated hemoglobin (HbA) of 7.47% in PC settings. Patients were randomized to TAU (n=27) or a web-based psychological treatment group (n=22). This web-based treatment consisted of cognitive behavioral therapy, improvement of diabetes self-care behaviors, and mindfulness. Cost-effectiveness analysis for the improvement of depressive symptomatology was conducted based on reductions in 3, 5, or 50 points on the Patient Health Questionnaire-9 (PHQ-9). The efficacy of diabetes control was estimated based on a 0.5% reduction in HbA levels. Follow-up was performed at 3 and 6 months. The cost-utility analysis was performed based on quality-adjusted life years.

RESULTS

Efficacy analysis showed that the web-based treatment program was more effective in improving depressive symptoms than TAU but showed only a slight improvement in HbA. Incremental cost-effectiveness ratios of 186.76 for a 3-point reduction in PHQ-9 and 206.31 for reductions of 5 and 50 percentage points were obtained. In contrast, the incremental cost-effectiveness ratio for improving HbA levels amounted to €1510.90 (€1=US $1.18 in 2018) per participant. The incremental cost-utility ratio resulted in €4119.33 per quality-adjusted life year gained.

CONCLUSIONS

The intervention, using web-based modules incorporating cognitive behavioral therapy tools, diabetes self-care promotion, and mindfulness, effectively reduced depressive symptoms and enhanced glycemic control in patients with T2DM. Notably, it demonstrated clinical efficacy and economic efficiency. This supports the idea that eHealth interventions not only benefit patients clinically but also offer cost-effectiveness for health care systems. The study emphasizes the importance of including specific modules to enhance diabetes self-care behaviors in future web-based psychological interventions, emphasizing personalization and adaptation for this population.

TRIAL REGISTRATION

ClinicalTrials.gov NCT03426709; https://clinicaltrials.gov/study/NCT03426709.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/S12888-019-2037-3.

摘要

背景

抑郁障碍和 2 型糖尿病(T2DM)在基层医疗保健中普遍存在。由于资源限制和面对面干预的困难,药物治疗尽管存在争议,但通常是首选的治疗方法。抑郁会显著影响一个人的生活的各个方面,影响对医疗处方的依从性和血糖控制,并导致未来的并发症和增加医疗保健费用。为了应对这些挑战,信息和通信技术(例如电子健康)已经被引入,并在改善治疗连续性和可及性方面显示出了前景。然而,虽然电子健康计划已经证明在缓解抑郁症状方面是有效的,但关于血糖控制的证据仍然不一致。本随机对照试验旨在测试通过网络应用程序对 T2DM 患者进行轻度至中度抑郁症状的低强度心理干预的疗效,与基层医疗保健中的常规治疗(TAU)相比。

目的

本研究旨在分析与 TAU 相比,在基层医疗保健环境中,通过网络为 T2DM 患者提供心理干预治疗抑郁症状的成本效益和成本效用。

方法

对 49 名 T2DM、中度严重抑郁症状和糖化血红蛋白(HbA)为 7.47%的患者进行了多中心随机对照试验。患者随机分为 TAU(n=27)或基于网络的心理治疗组(n=22)。这种基于网络的治疗包括认知行为疗法、改善糖尿病自我护理行为和正念。根据 3、5 或 50 点的患者健康问卷-9(PHQ-9)改善抑郁症状进行成本效益分析。根据 HbA 水平降低 0.5%估计糖尿病控制的疗效。在 3 个月和 6 个月时进行随访。根据质量调整生命年来进行成本效用分析。

结果

疗效分析表明,网络治疗方案在改善抑郁症状方面比 TAU 更有效,但对 HbA 水平的改善仅略有改善。获得了 PHQ-9 降低 3 分的 186.76 欧元增量成本效益比和降低 5 分和 50 分的 206.31 欧元增量成本效益比。相比之下,改善 HbA 水平的增量成本效益比为每位参与者 1510.90 欧元(2018 年 1 欧元=1.18 美元)。增量成本效用比导致每获得一个质量调整生命年需花费 4119.33 欧元。

结论

该干预措施使用基于网络的模块,结合认知行为疗法工具、促进糖尿病自我护理行为和正念,有效降低了 T2DM 患者的抑郁症状并改善了血糖控制。值得注意的是,它具有临床疗效和经济效益。这支持了电子健康干预不仅对患者具有临床益处,而且对医疗保健系统也具有成本效益的观点。该研究强调了在未来的基于网络的心理干预中纳入特定模块以增强糖尿病自我护理行为的重要性,强调针对该人群的个性化和适应性。

试验注册

ClinicalTrials.gov NCT03426709; https://clinicaltrials.gov/study/NCT03426709.

国际注册报告标识符(IRRID):RR2-10.1186/S12888-019-2037-3.

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b7cc/11140277/551649b53917/mhealth_v12i1e55483_fig5.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b7cc/11140277/378791377dcb/mhealth_v12i1e55483_fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b7cc/11140277/2c2b9b2f911e/mhealth_v12i1e55483_fig2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b7cc/11140277/f65cd00418c0/mhealth_v12i1e55483_fig3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b7cc/11140277/4bae2e0a78d9/mhealth_v12i1e55483_fig4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b7cc/11140277/551649b53917/mhealth_v12i1e55483_fig5.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b7cc/11140277/378791377dcb/mhealth_v12i1e55483_fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b7cc/11140277/2c2b9b2f911e/mhealth_v12i1e55483_fig2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b7cc/11140277/f65cd00418c0/mhealth_v12i1e55483_fig3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b7cc/11140277/4bae2e0a78d9/mhealth_v12i1e55483_fig4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b7cc/11140277/551649b53917/mhealth_v12i1e55483_fig5.jpg

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