Asia Diabetes Foundation, Shatin, Hong Kong Special Administrative Region (SAR), China.
Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, Hong Kong SAR, China.
JAMA Netw Open. 2022 Mar 1;5(3):e223862. doi: 10.1001/jamanetworkopen.2022.3862.
Diabetic kidney disease (DKD) and its comorbidities can be prevented by treating multiple targets. Technology-assisted team-based care with regular feedback and patient empowerment can improve the attainment of multiple targets and clinical outcomes in patients with type 2 diabetes, but the effects of this intervention on patients with DKD are unclear.
To evaluate the effect of the Joint Asia Diabetes Evaluation (JADE) web portal, nurse reminders, and team-based care on multiple risk factors in patients with DKD.
DESIGN, SETTING, AND PARTICIPANTS: This 12-month multinational, open-label randomized clinical trial was conducted between June 27, 2014, and February 19, 2019, at 13 hospital-based diabetes centers in 8 countries or regions in Asia. All patients who participated had DKD. The intention-to-treat data analysis was performed from April 7 to June 30, 2020.
Patients were randomized in a 1:1:1 ratio at each site to usual care, empowered care, or team-based empowered care. All patients underwent a JADE web portal-guided structured assessment at baseline and month 12. Patients in the usual care and empowered care groups received a medical follow-up. Patients in the empowered care group also received a personalized JADE report and nurse telephone calls every 3 months. Patients in the team-based empowered care group received additional face-to-face reviews every 3 months from a physician-nurse team.
The primary outcome was the proportion of patients who attained multiple treatment targets (defined as ≥3 of 5 targets: HbA1c level <7.0% [53 mmol/mol], blood pressure <130/80 mm Hg, low-density lipoprotein cholesterol level <1.8 mmol/L, triglyceride level <1.7 mmol/L, and/or persistent use of renin-angiotensin-aldosterone system inhibitors).
A total of 2393 patients (mean [SD] age, 67.7 [9.8] years; 1267 men [52.9%]) were randomized to the usual care group (n = 795), empowered care group (n = 802), and team-based empowered care group (n = 796). At baseline, 34.7% patients (n = 830) were on 3 treatment targets. On intention-to-treat analysis, the team-based empowered care group had the highest proportion of patients who had further increase in attainment of multiple treatment targets (within-group differences: usual care group, 3.9% [95% CI, 0.0%-7.8%]; empowered care group, 1.3% [95% CI, -2.8% to 5.4%]; team-based empowered care group, 9.1% [95% CI, 4.7%-13.5%]). The team-based empowered care group was more likely to attain multiple treatment targets than the usual care group (risk ratio [RR], 1.17; 95% CI, 1.00-1.37) and the empowered care group (RR, 1.25; 95% CI, 1.06-1.48) after adjustment for site. Compared with the group that did not attain multiple treatment targets, the group that attained multiple treatment targets reported a lower incidence of cardiovascular, kidney, and cancer events (8.4% [n = 51] vs 14.5% [n = 134]; P = .004). Analysis of the per-protocol population yielded similar results.
This trial found that technology-assisted team-based care for 12 months improved the attainment of multiple treatment targets as well as empowerment in patients with DKD.
ClinicalTrials.gov Identifier: NCT02176278.
通过治疗多个靶点,可以预防糖尿病肾病(DKD)及其合并症。通过技术辅助的团队为基础的护理,并定期反馈和赋予患者权力,可以改善 2 型糖尿病患者多个目标的实现和临床结局,但这种干预对 DKD 患者的效果尚不清楚。
评估联合亚洲糖尿病评估(JADE)门户网站、护士提醒和以团队为基础的护理对 DKD 患者多个危险因素的影响。
设计、地点和参与者:这是一项跨国、开放标签、随机临床试验,于 2014 年 6 月 27 日至 2019 年 2 月 19 日在亚洲 8 个国家或地区的 13 家医院糖尿病中心进行。所有参与者均患有 DKD。意向治疗数据分析于 2020 年 4 月 7 日至 6 月 30 日进行。
患者在每个站点以 1:1:1 的比例随机分配到常规护理、授权护理或以团队为基础的授权护理。所有患者在基线和第 12 个月都接受了 JADE 门户网站指导的结构化评估。常规护理组和授权护理组的患者接受了医疗随访。授权护理组的患者还每 3 个月接受一次个性化的 JADE 报告和护士电话。团队授权护理组的患者每 3 个月还接受一次医生-护士团队的面对面审查。
主要结局是达到多个治疗目标(定义为≥5 个目标中的 3 个:HbA1c 水平<7.0%(53 mmol/mol)、血压<130/80 mmHg、低密度脂蛋白胆固醇水平<1.8 mmol/L、三酰甘油水平<1.7 mmol/L 和/或持续使用肾素-血管紧张素-醛固酮系统抑制剂)的患者比例。
共有 2393 名患者(平均[标准差]年龄,67.7[9.8]岁;1267 名男性[52.9%])被随机分配到常规护理组(n=795)、授权护理组(n=802)和以团队为基础的授权护理组(n=796)。基线时,34.7%的患者(n=830)有 3 个治疗目标。意向治疗分析显示,以团队为基础的授权护理组有更高比例的患者进一步增加了达到多个治疗目标(组内差异:常规护理组 3.9%[95%CI,0.0%-7.8%];授权护理组 1.3%[95%CI,-2.8%-5.4%];以团队为基础的授权护理组 9.1%[95%CI,4.7%-13.5%])。与常规护理组相比,以团队为基础的授权护理组更有可能达到多个治疗目标(风险比[RR],1.17;95%CI,1.00-1.37)和授权护理组(RR,1.25;95%CI,1.06-1.48),调整了站点因素。与未达到多个治疗目标的患者相比,达到多个治疗目标的患者报告心血管、肾脏和癌症事件的发生率较低(8.4%[n=51]vs 14.5%[n=134];P=0.004)。对符合方案人群的分析得出了类似的结果。
这项试验发现,为期 12 个月的技术辅助的以团队为基础的护理可以改善 DKD 患者多个治疗目标的实现和授权。
ClinicalTrials.gov 标识符:NCT02176278。