Effect of patient-centered self-management intervention on glycemic control, self-efficacy, and self-care behaviors in South Asian adults with type 2 diabetes mellitus: A multicenter randomized controlled trial

IF 3 2区 医学 Q2 ENDOCRINOLOGY & METABOLISM
Kainat Asmat, Erika Sivarajan Froelicher, Khairunnisa Aziz Dhamani, Raisa Gul, Nazeer Khan
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Abstract

Background

This study aimed to test the efficacy of patient-centered self-management intervention (PACE-SMI) to improve HbA1c, self-efficacy, and self-care behaviors in adults with type 2 diabetes mellitus (T2DM).

Methods

In this multicenter, parallel two-arm randomized controlled trial, 612 adults with T2DM and HbA1c ≥ 7% were enrolled and assigned to the control group (n = 310) and the intervention group (n = 302) using stratified permuted block randomization. The control group received usual care, whereas the intervention group received usual care plus nurse-led, theory-driven, culturally tailored PACE-SMI, comprising eight weekly sessions of individualized education, counseling, behavioral training, and home visit. Outcomes were assessed at baseline, postintervention, and 3 months follow-up.

Results

Data at 3 months were provided by 583 participants (control: n = 295, intervention: n = 288). Per-protocol analysis showed that the intervention group had a lower mean HbA1c (8.49% [standard deviation (SD), 1.58]) than the control group (8.74% [SD, 1.62]), with small yet statistically significant mean difference of 0.25% (95% confidence interval [CI], −0.01 to 0.51; Cohen's d = 0.16; p = 0.03). Self-efficacy and self-care behaviors significantly improved in the intervention group (116.89 [SD, 25.50] and 70.01 [SD, 17.97]) compared to the control group (75.43 [SD, 18.99] and 51.54 [SD, 12.04]), with mean differences of 41.48 (95% CI, 37.83–45.13; Cohen's d = 1.84; p < 0.0001) and 18.56 (95% CI, 16.08–21.04; Cohen's d = 1.22; p < 0.0001), respectively. Linear regression analysis indicated the effect of PACE-SMI on HbA1c was significantly mediated by improvements in self-efficacy and self-care behaviors (R2 = 0.232, p < 0.001).

Conclusion

PACE-SMI led to modest but significant improvement in HbA1c and substantial enhancements in self-efficacy and self-care behaviors in adults with T2DM.

Abstract Image

以患者为中心的自我管理干预对南亚成年 2 型糖尿病患者血糖控制、自我效能和自我护理行为的影响:多中心随机对照试验
背景 本研究旨在检验以患者为中心的自我管理干预(PACE-SMI)对改善 2 型糖尿病(T2DM)成人患者 HbA1c、自我效能和自我护理行为的疗效。 方法 在这项多中心、平行双臂随机对照试验中,612 名 HbA1c ≥ 7% 的 T2DM 成人被纳入试验,并采用分层包块随机法分配到对照组(n = 310)和干预组(n = 302)。对照组接受常规护理,而干预组则接受常规护理外加护士主导、理论驱动、文化定制的 PACE-SMI,包括每周八次的个性化教育、咨询、行为训练和家访。结果在基线、干预后和 3 个月随访时进行评估。 结果 583 名参与者提供了 3 个月的数据(对照组:n = 295,干预组:n = 288)。按协议分析显示,干预组的 HbA1c 平均值(8.49% [标准差 (SD), 1.58])低于对照组(8.74% [标准差 (SD), 1.62]),平均值相差 0.25%(95% 置信区间 [CI],-0.01 至 0.51;Cohen's d = 0.16;P = 0.03),差异虽小,但具有统计学意义。与对照组(75.43 [SD, 18.99] 和 51.54 [SD, 12.04])相比,干预组的自我效能感和自我护理行为明显提高(116.89 [SD, 25.50] 和 70.01 [SD, 17.97]),平均差异为 0.25%(95% 置信区间 [CI] -0.01 至 0.51;Cohen d = 0.16;P = 0.03)。04]),平均差异分别为 41.48(95% CI,37.83-45.13;Cohen's d = 1.84;p <;0.0001)和 18.56(95% CI,16.08-21.04;Cohen's d = 1.22;p <;0.0001)。线性回归分析表明,PACE-SMI 对 HbA1c 的影响显著介于自我效能和自我护理行为的改善之间(R2 = 0.232,p < 0.001)。 结论 PACE-SMI 对成人 T2DM 患者的 HbA1c 有轻微但显著的改善,并大大提高了自我效能和自我护理行为。
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来源期刊
Journal of Diabetes
Journal of Diabetes ENDOCRINOLOGY & METABOLISM-
CiteScore
6.50
自引率
2.20%
发文量
94
审稿时长
>12 weeks
期刊介绍: Journal of Diabetes (JDB) devotes itself to diabetes research, therapeutics, and education. It aims to involve researchers and practitioners in a dialogue between East and West via all aspects of epidemiology, etiology, pathogenesis, management, complications and prevention of diabetes, including the molecular, biochemical, and physiological aspects of diabetes. The Editorial team is international with a unique mix of Asian and Western participation. The Editors welcome submissions in form of original research articles, images, novel case reports and correspondence, and will solicit reviews, point-counterpoint, commentaries, editorials, news highlights, and educational content.
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