Faculty of Nursing and Midwifery, Shifa Tameer-e-Millat University, Islamabad, Pakistan.
Department of Physiological Nursing, School of Nursing, University of California, San Francisco, California, USA.
J Diabetes. 2024 Sep;16(9):e13611. doi: 10.1111/1753-0407.13611.
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).
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.
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 (R = 0.232, p < 0.001).
PACE-SMI led to modest but significant improvement in HbA1c and substantial enhancements in self-efficacy and self-care behaviors in adults with T2DM.
本研究旨在检验以患者为中心的自我管理干预（PACE-SMI）在改善 2 型糖尿病（T2DM）成人的糖化血红蛋白（HbA1c）、自我效能和自我护理行为方面的疗效。
在这项多中心、平行双臂随机对照试验中，纳入了 612 名糖化血红蛋白（HbA1c）≥7%的 T2DM 成人，并采用分层区组随机化方法分为对照组（n=310）和干预组（n=302）。对照组接受常规护理，而干预组接受护士主导、基于理论、文化适应的 PACE-SMI，包括八次个性化教育、咨询、行为培训和家访。在基线、干预后和 3 个月随访时评估结局。
583 名参与者（对照组：n=295，干预组：n=288）提供了 3 个月的数据。意向治疗分析显示，干预组的平均 HbA1c（8.49%[标准差（SD），1.58%]）低于对照组（8.74%[SD，1.62%]），差异具有统计学意义，均值差为 0.25%（95%置信区间[CI]，-0.01 至 0.51；Cohen's d=0.16；p=0.03）。与对照组相比，干预组的自我效能（116.89[SD，25.50]）和自我护理行为（70.01[SD，17.97]）显著提高，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 的影响主要通过自我效能和自我护理行为的改善来介导（R=0.232，p<0.001）。
PACE-SMI 可使 T2DM 成人的 HbA1c 适度改善，自我效能和自我护理行为显著增强。
