通过电话进行护士远程支持对2型糖尿病患者专科护理与初级护理之间过渡的影响:一项符合CONSORT标准的随机临床试验。
Effects of nurse tele support via telephone calls on transition between specialized and primary care in type 2 diabetes mellitus patients: a CONSORT-compliant randomized clinical trial.
作者信息
Moreira Ana Marina, Rados Dimitris Varvaki, de Farias Camila Bergonsi, Coelli Sabrina, de Almeida Faller Livia, Dos Santos Laura Ferraz, Matzenbacher Ana Maria, Katz Natan, Harzeim Erno, Silveiro Sandra Pinho
机构信息
Postgraduate Program in Medical Sciences: Endocrinology, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.
Diabetes and Metabolism Group, Clinical Research Center-(HCPA), Porto Alegre, Rio Grande do Sul, Brazil.
出版信息
Endocrine. 2025 Mar;87(3):978-986. doi: 10.1007/s12020-024-04095-6. Epub 2024 Nov 29.
BACKGROUND
The role of telemedicine in the transition to primary care for type 2 diabetes mellitus (T2DM) is yet unknown. We aimed to evaluate this issue in well-controlled T2DM patients discharged from a tertiary clinic.
METHODS
This is a CONSORT-compliant 12-month randomized clinical trial (RCT). T2DM patients with glycated hemoglobin (HbA1c) < 8%, being discharged to primary care from a tertiary clinic, were recruited. The intervention group periodically received nurse phone calls focusing on education. The control group received primary care as usual. The main outcome was glycemic control (HbA1c) at 12 months.
RESULTS
147 patients were randomized (73 in intervention vs. 74 in control groups) with no differences in baseline data. After one year, we found no differences between groups in HbA1c (7.46% ± 1.37 in intervention vs. 7.54% ± 1.6 in control group; P = 0.76). HbA1c slightly increased from baseline in both groups (0.46% in intervention vs. 0.64% in control group) at 12 months, without differences between them (P = 0.69).
CONCLUSIONS
A telemedicine intervention based on phone calls plus primary care shows a similar effect to primary care alone on T2DM patients' HbA1c after tertiary clinic discharge. Patients remained with a reasonable HbA1c during the trial, suggesting that the transition to primary care was safe.
TRIAL REGISTRATION
Clinical Trials, NCT02768480. Registered on April 29, 2016.
背景
远程医疗在2型糖尿病(T2DM)向初级保健过渡中的作用尚不清楚。我们旨在评估三级诊所出院的血糖控制良好的T2DM患者的这一问题。
方法
这是一项符合CONSORT标准的为期12个月的随机临床试验(RCT)。招募糖化血红蛋白(HbA1c)<8%、从三级诊所出院并转至初级保健的T2DM患者。干预组定期接受以教育为重点的护士电话随访。对照组照常接受初级保健。主要结局是12个月时的血糖控制(HbA1c)。
结果
147例患者被随机分组(干预组73例,对照组74例),基线数据无差异。一年后,我们发现两组之间的HbA1c无差异(干预组为7.46%±1.37,对照组为7.54%±1.6;P = 0.76)。12个月时,两组的HbA1c均较基线略有升高(干预组为0.46%,对照组为0.64%),但两组之间无差异(P = 0.69)。
结论
基于电话随访加初级保健的远程医疗干预在三级诊所出院后的T2DM患者HbA1c方面显示出与单纯初级保健相似的效果。试验期间患者的HbA1c保持在合理水平,表明向初级保健的过渡是安全的。
试验注册
临床试验,NCT02768?480。于2016年4月29日注册。