糖尿病相关足部溃疡的远程医疗干预对健康、幸福感和生活质量的影响：一项群组随机对照试验（DiaFOTo）的次要结局。
Effect of a telemedicine intervention for diabetes-related foot ulcers on health, well-being and quality of life: secondary outcomes from a cluster randomized controlled trial (DiaFOTo).
机构信息
Faculty of Health and Social Sciences, Department of Health and Caring Sciences, Western Norway University of Applied Sciences, N-5020, Bergen, Norway.
Department of Medicine, Section of Endocrinology, Stavanger University Hospital, Stavanger, Norway.
出版信息
BMC Endocr Disord. 2020 Oct 21;20(1):157. doi: 10.1186/s12902-020-00637-x.
BACKGROUND
Follow-up care provided via telemedicine (TM) is intended to be a more integrated care pathway to manage diabetes-related foot ulcers (DFU) than traditionally-delivered healthcare. However, knowledge of the effect of TM follow-up on PROMs including self-reported health, well-being and QOL in patients with DFUs is lacking and often neglected in RCT reports in general. Therefore, in this study of secondary outcomes from the DiaFOTo trial, the aim was to compare changes in self-reported health, well-being and QOL between patients with DFUs receiving telemedicine follow-up care in primary healthcare in collaboration with specialist healthcare, and patients receiving standard outpatient care.
METHODS
The current study reports secondary endpoints from a cluster randomized controlled trial whose primary endpoint was ulcer healing time. The trial included 182 adults with diabetes-related foot ulcers (94/88 in the telemedicine/standard care groups) in 42 municipalities/districts, recruited from three clinical sites in Western Norway. Mean (SD) diabetes duration for the study population was 20.8 (15.0). The intervention group received care in the community in collaboration with specialist healthcare using an asynchronous telemedicine intervention. The intervention included an interactive web-based ulcer record and a mobile phone enabling counseling and communication between the community nurses and specialist healthcare; the control group received standard outpatient care. In total 156 participants (78/78) reported on secondary endpoints: self-reported health, well-being and quality of life evaluated by generic and disease-specific patient-reported outcome measures (e.g. Euro-QOL, the Hospital Anxiety and Depression Scale (HADS), Problem Areas in Diabetes (PAID), Neuropathy and Foot Ulcer-Specific Quality of Life Instrument (NeuroQOL)). Linear mixed-effects regression was used to investigate possible differences in changes in the scores between the intervention and control group at the end of follow-up.
RESULTS
In intention to treat analyses, differences between treatment groups were small and non-significant for the health and well-being scale scores, as well as for diabetes-related distress and foot ulcer-specific quality of life.
CONCLUSIONS
There were no significant differences in changes in scores for the patient reported outcomes between the intervention and control group, indicating that the intervention did not affect the participants' health, well-being and quality of life.
TRIAL REGISTRATION
Clinicaltrials.gov , NCT01710774 . Registered October 19th, 2012.
背景
与传统医疗保健相比，通过远程医疗（TM）提供的随访护理旨在成为一种更综合的管理糖尿病相关足部溃疡（DFU）的护理途径。然而，对于接受 DFU 治疗的患者通过 TM 随访对 PROMs（包括自我报告的健康、幸福感和生活质量）的影响知之甚少，且通常在 RCT 报告中被忽视。因此，在 DiaFOTo 试验的二次结果研究中，目的是比较接受远程医疗随访护理的初级保健协作专科医疗的 DFU 患者与接受标准门诊护理的患者之间自我报告的健康、幸福感和生活质量的变化。
方法
本研究报告了一项聚类随机对照试验的次要终点，该试验的主要终点是溃疡愈合时间。该试验纳入了来自挪威西部三个临床地点的 42 个市/区的 182 名糖尿病相关足部溃疡（远程医疗/标准护理组各 94/88 名）患者，该研究人群的糖尿病病程平均（标准差）为 20.8（15.0）年。干预组在社区中接受与专科医疗协作的护理，采用异步远程医疗干预。干预措施包括一个交互式的基于网络的溃疡记录和一部手机，使社区护士和专科医疗之间能够进行咨询和沟通；对照组接受标准门诊护理。共有 156 名参与者（78/78）报告了次要终点：使用通用和疾病特异性患者报告的结果测量（例如 Euro-QOL、医院焦虑和抑郁量表（HADS）、糖尿病问题领域（PAID）、神经病变和足部溃疡特异性生活质量量表（NeuroQOL））评估自我报告的健康、幸福感和生活质量。使用线性混合效应回归分析来研究在随访结束时，干预组和对照组之间的评分变化是否存在差异。
结果
在意向治疗分析中，治疗组之间的差异较小，且健康和幸福感量表评分以及糖尿病相关困扰和足部溃疡特异性生活质量评分均无统计学意义。
结论
干预组和对照组之间患者报告结局的评分变化无显著差异，表明干预并未影响参与者的健康、幸福感和生活质量。
试验注册
Clinicaltrials.gov，NCT01710774。于 2012 年 10 月 19 日注册。
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