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针对接受家庭医生签约服务的2型糖尿病患者的家庭自我管理干预措施的有效性:一项基于社区的随机对照试验。

Effectiveness of a Family-Based Self-Management Intervention for Type 2 Diabetes Patients Receiving Family Doctor Contract Services: A Community-Based Randomized Controlled Trial.

作者信息

Zhu Lan, Wang Jing, Pan Zhigang, Zhang Wei, Tang Jing, Yan Hua, Shen Fulai, Shen Yi

机构信息

Zhongshan Hospital Affiliated to Fudan University, Shanghai, China.

Xietu Street Community Health Service Center, Xuhui District, Shanghai, China.

出版信息

J Prim Care Community Health. 2025 Jan-Dec;16:21501319251330384. doi: 10.1177/21501319251330384. Epub 2025 Mar 31.

DOI:10.1177/21501319251330384
PMID:40162887
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11960157/
Abstract

INTRODUCTION

The community-based management of type 2 diabetes in China remains suboptimal. Incorporating family support presents a promising approach to enhancing facilitators and addressing barriers to effective diabetes self-management, particularly in the Chinese context where familial relationships and collective family responsibility play a central role in health-related decision-making and daily life. We aimed to validate a family support-based self-management behavioral intervention program, Systematic evaluation, core education, self-directed planning, triple feedback, and develop a habit program (SeCe-STRIVE). The program comprises 5 modules: systematic evaluation, core education, self-directed planning, triple feedback, and habit development.

RESEARCH DESIGN AND METHODS

We conducted a community-based, single-center, parallel randomized controlled trial in the Xietu community of Xuhui District, Shanghai. Eligible patients were randomly assigned to either the intervention or control group. Participants in the intervention group received the SeCe-STRIVE health management program based on family support, while those in the control group received the community-based follow-up management program for type 2 diabetes. The primary outcome measured was the total self-management behavior score and its changes across various dimensions from baseline. Secondary outcomes included family support, family function, diabetes knowledge, quality of life, self-efficacy, and biochemical markers. Post-intervention changes in both primary and secondary outcomes relative to baseline were analyzed using analysis of covariance.

RESULTS

The study ultimately included 113 participants in the intervention group and 112 in the control group. The intervention group's total self-management behavior score improved by 12.74 (95% CI = 10.07, 15.40,  < .001) points more than the control group. Across all dimensions of self-management behaviors, the intervention group showed greater improvement, including diet, exercise, blood glucose monitoring, foot care, and medication adherence. Participants with low family support exhibited greater improvements in self-management behaviors compared to those with high family support. The intervention group demonstrated significant improvements in family support, family function, diabetes knowledge, and self-efficacy. Although quality of life and biochemical indicators of glycated hemoglobin, fasting blood glucose, and blood lipids showed a decreasing trend, the differences were not statistically significant.

CONCLUSIONS

Compared to the control group, patients with type 2 diabetes who received the SeCe-STRIVE program intervention showed significant improvements in self-management behaviors, accompanied by enhancements in family support, family functioning, and self-efficacy. Further large-scale, multi-center trials with longer follow-up periods are needed to confirm these results.

TRIAL REGISTRATION

ChiCTR, ChiCTR2200060416. Registered 01 June 2022, https://www.chictr.org.cn/showproj.html?proj=167086.

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e4a1/11960157/10321151e1ac/10.1177_21501319251330384-fig4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e4a1/11960157/e6d8c5851478/10.1177_21501319251330384-fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e4a1/11960157/2950a39c543a/10.1177_21501319251330384-fig2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e4a1/11960157/844ac1ecb40a/10.1177_21501319251330384-fig3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e4a1/11960157/10321151e1ac/10.1177_21501319251330384-fig4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e4a1/11960157/e6d8c5851478/10.1177_21501319251330384-fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e4a1/11960157/2950a39c543a/10.1177_21501319251330384-fig2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e4a1/11960157/844ac1ecb40a/10.1177_21501319251330384-fig3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e4a1/11960157/10321151e1ac/10.1177_21501319251330384-fig4.jpg
摘要

引言

中国2型糖尿病的社区管理仍不尽人意。纳入家庭支持是一种很有前景的方法,可以增强促进因素并消除有效糖尿病自我管理的障碍,特别是在中国这样的背景下,家庭关系和家庭集体责任在健康相关决策和日常生活中起着核心作用。我们旨在验证一个基于家庭支持的自我管理行为干预项目,即系统评估、核心教育、自主规划、三重反馈和习惯养成项目(SeCe-STRIVE)。该项目包括5个模块:系统评估、核心教育、自主规划、三重反馈和习惯养成。

研究设计与方法

我们在上海徐汇区斜土社区进行了一项基于社区的单中心平行随机对照试验。符合条件的患者被随机分配到干预组或对照组。干预组的参与者接受基于家庭支持的SeCe-STRIVE健康管理项目,而对照组的参与者接受2型糖尿病的社区随访管理项目。测量的主要结果是自我管理行为总分及其从基线开始在各个维度上的变化。次要结果包括家庭支持、家庭功能、糖尿病知识、生活质量、自我效能和生化指标。使用协方差分析来分析干预后主要和次要结果相对于基线的变化。

结果

该研究最终纳入干预组113名参与者和对照组112名参与者。干预组的自我管理行为总分比对照组提高了12.74(95%CI = 10.07,15.40,<0.001)分。在自我管理行为的所有维度上,干预组都有更大的改善,包括饮食、运动、血糖监测、足部护理和药物依从性。与家庭支持高的参与者相比,家庭支持低的参与者在自我管理行为方面有更大的改善。干预组在家庭支持、家庭功能、糖尿病知识和自我效能方面有显著改善。尽管生活质量以及糖化血红蛋白、空腹血糖和血脂的生化指标呈下降趋势,但差异无统计学意义。

结论

与对照组相比,接受SeCe-STRIVE项目干预的2型糖尿病患者在自我管理行为方面有显著改善,同时家庭支持、家庭功能和自我效能也有所增强。需要进一步进行大规模、多中心试验并延长随访期以证实这些结果。

试验注册

中国临床试验注册中心,ChiCTR2200060416。于2022年6月1日注册,https://www.chictr.org.cn/showproj.html?proj=167086。

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