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Effect of a web-based management guide on risk factors in patients with type 2 diabetes and diabetic kidney disease: a JADE randomized clinical trial [with consumer summary] |
Chan JCN, Thewjitcharoen Y, Nguyen TK, Tan A, Chia Y-C, Hwu C-M, Jian D, Himathongkam T, Wong K-L, Choi Y-M, Mirasol R, Mohamed M, Kong APS, Ma RCW, Chow EYK, Ozaki R, Lau V, Fu AWC, Hong E-G, Yoon K-H, Tsang C-C, Lau ESH, Lim L-L, Luk AOY |
JAMA Network Open 2022 Mar;5(3):e223862 |
clinical trial |
6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: No; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
IMPORTANCE: 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. OBJECTIVE: 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. INTERVENTIONS: 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. MAIN OUTCOMES AND MEASURES: 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). RESULTS: A total of 2,393 patients (mean (SD) age, 67.7 (9.8) years; 1,267 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% to 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% to 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 to 1.37) and the empowered care group (RR, 1.25; 95% CI 1.06 to 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) versus 14.5% (n = 134); p = 0.004). Analysis of the per-protocol population yielded similar results. CONCLUSIONS AND RELEVANCE: 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. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02176278.
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