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基于移动健康补充的足部温度测量预防糖尿病足溃疡:一项随机对照试验。

Foot thermometry with mHeath-based supplementation to prevent diabetic foot ulcers: A randomized controlled trial.

作者信息

Lazo-Porras Maria, Bernabe-Ortiz Antonio, Taype-Rondan Alvaro, Gilman Robert H, Malaga German, Manrique Helard, Neyra Luis, Calderon Jorge, Pinto Miguel, Armstrong David G, Montori Victor M, Miranda J Jaime

机构信息

CRONICAS Centre of Excellence in Chronic Diseases, Universidad Peruana Cayetano Heredia, Lima, Peru.

School of Public Health and Administration, Universidad Peruana Cayetano Heredia, Lima, Peru.

出版信息

Wellcome Open Res. 2020 Aug 28;5:23. doi: 10.12688/wellcomeopenres.15531.2. eCollection 2020.

Abstract

: Novel approaches to reduce diabetic foot ulcers (DFU) in low- and middle-income countries are needed. Our objective was to compare incidence of DFUs in the thermometry plus mobile health (mHealth) reminders (intervention) vs. thermometry-only (control). : We conducted a randomized trial enrolling adults with type 2 diabetes mellitus at risk of foot ulcers (risk groups 2 or 3) but without foot ulcers at the time of recruitment, and allocating them to control (instruction to use a liquid crystal-based foot thermometer daily) or intervention (same instruction supplemented with text and voice messages with reminders to use the device and messages to promote foot care) groups, and followed for 18 months. The primary outcome was time to occurrence of DFU. A process evaluation was also conducted. : A total of 172 patients (63% women, mean age 61 years) were enrolled; 86 to each study group. More patients enrolled in the intervention arm had a history of previous DFU (66% vs. 48%). Follow-up for the primary endpoint was complete for 158 of 172 participants (92%). Adherence to ≥80% of daily temperature measurements was 87% (103 of 118) among the study participants who returned the logbook. DFU cumulative incidence was 24% (19 of 79) in the intervention arm and 11% (9 of 79) in the control arm. After adjusting for history of foot ulceration and study site, the hazard ratio (HR) for DFU was 1.44 (95% CI 0.65, 3.22). : In our study, conducted in a low-income setting, the addition of mHealth to foot thermometry was not effective in reducing foot ulceration. Importantly, there was a higher rate of previous DFU in the intervention group, the adherence to thermometry was high, and the expected rates of DFU used in our sample size calculations were not met. : ClinicalTrials.gov NCT02373592 (27/02/2015).

摘要

需要采取新方法来减少低收入和中等收入国家的糖尿病足溃疡(DFU)。我们的目标是比较体温测量加移动健康(mHealth)提醒(干预组)与仅体温测量(对照组)的DFU发病率。:我们进行了一项随机试验,招募有足部溃疡风险(风险等级2或3)但在招募时无足部溃疡的2型糖尿病成年患者,并将他们分配到对照组(每天使用基于液晶的足部温度计的指导)或干预组(相同指导并辅以文本和语音消息,提醒使用该设备并发送促进足部护理的消息),随访18个月。主要结局是发生DFU的时间。还进行了过程评估。:共招募了172名患者(63%为女性,平均年龄61岁);每个研究组86名。干预组中更多患者有既往DFU病史(66%对48%)。172名参与者中有158名(92%)完成了主要终点的随访。在归还日志的研究参与者中,≥80%的每日体温测量依从率为87%(118名中的103名)。干预组DFU累积发病率为24%(79名中的19名),对照组为11%(79名中的9名)。在调整足部溃疡病史和研究地点后,DFU的风险比(HR)为1.44(95%CI 0.65,3.22)。:在我们于低收入环境中进行的研究中,在足部体温测量基础上增加mHealth对减少足部溃疡无效。重要的是,干预组既往DFU发生率较高,体温测量依从性高,且我们样本量计算中使用的DFU预期发生率未达到。:ClinicalTrials.gov NCT02373592(2015年2月27日)

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/282f/7463869/a8359a47c82b/wellcomeopenres-5-17701-g0000.jpg

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