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自动化个性化 2 型糖尿病患者自我护理计划:一项试点试验。

Automated Personalized Self-care Program for Patients With Type 2 Diabetes Mellitus: A Pilot Trial.

机构信息

Department of Nursing/Research Institute of Nursing Science, Pusan National University, South Korea.

Department of Nursing, Pukyoung National University, South Korea.

出版信息

Asian Nurs Res (Korean Soc Nurs Sci). 2024 May;18(2):114-124. doi: 10.1016/j.anr.2024.04.003. Epub 2024 Apr 25.

DOI:10.1016/j.anr.2024.04.003
PMID:38677472
Abstract

PURPOSE

Providing continuous self-care support to the growing diabetes population is challenging. Strategies are needed to enhance engagement in self-care, utilizing innovative technologies for personalized feedback. This study aimed to assess the feasibility of the Automated Personalized Self-Care program among type 2 diabetes patients and evaluate its preliminary effectiveness.

METHODS

A parallel randomized pilot trial with qualitative interviews occurred from May 3, 2022, to September 27, 2022. Participants aged 40-69 years with type 2 diabetes and HbA1c ≥ 7.0% were recruited. The three-month program involved automated personalized goal setting, education, monitoring, and feedback. Feasibility was measured by participants' engagement and intervention usability. Preliminary effectiveness was examined through self-care self-efficacy, self-care behaviors, and health outcomes. Qualitative interviews were conducted with the intervention group.

RESULTS

A total of 404 patients were screened. Out of the 61 eligible patients, 32 were enrolled, resulting in a recruitment rate of 52.5%. Retention rates at three months were 84.2% and 84.6% in the intervention and control groups, respectively. Among the intervention group, 81.3% satisfied adherence criteria. Mobile application's usability scored 66.25, and participants' satisfaction was 8.06. Intention-to-treat analysis showed improvements in self-measured blood glucose testing, grain intake, and HbA1c in the intervention group. Qualitative content analysis identified nine themes.

CONCLUSION

Feasibility of the program was verified. A larger randomized controlled trial is needed to determine its effectiveness in self-care self-efficacy, self-care behaviors, and health outcomes among type 2 diabetes patients. This study offers insights for optimizing future trials assessing clinical effectiveness.

TRIAL REGISTRATION

Clinical Research Information Service, KCT0008202 (registration date: 17 February 2023).

摘要

目的

为不断增长的糖尿病患者提供持续的自我护理支持极具挑战性。需要利用创新技术提供个性化反馈来增强自我护理的参与度。本研究旨在评估 2 型糖尿病患者使用自动化个性化自我护理计划的可行性,并评估其初步效果。

方法

这是一项 2022 年 5 月 3 日至 9 月 27 日进行的平行随机试验性试点研究,包括定性访谈。招募年龄在 40-69 岁、患有 2 型糖尿病且糖化血红蛋白(HbA1c)≥7.0%的患者。为期三个月的方案包括自动化个性化目标设定、教育、监测和反馈。通过参与者的参与度和干预措施的可用性来衡量可行性。通过自我护理自我效能感、自我护理行为和健康结果来检验初步效果。对干预组进行了定性访谈。

结果

共筛选出 404 名患者。在 61 名符合条件的患者中,有 32 名入组,招募率为 52.5%。干预组和对照组的三个月保留率分别为 84.2%和 84.6%。在干预组中,81.3%的患者符合依从性标准。移动应用程序的可用性评分为 66.25,参与者的满意度为 8.06。意向治疗分析显示,干预组的自我监测血糖测试、谷物摄入量和糖化血红蛋白有所改善。定性内容分析确定了九个主题。

结论

该方案的可行性得到了验证。需要更大规模的随机对照试验来确定其在 2 型糖尿病患者自我护理自我效能感、自我护理行为和健康结果方面的效果。本研究为优化未来评估临床效果的试验提供了见解。

试验注册

临床研究信息服务,KCT0008202(注册日期:2023 年 2 月 17 日)。

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