Department of Health Science and Technology, Aalborg University, Denmark.
J Telemed Telecare. 2020 Aug-Sep;26(7-8):452-461. doi: 10.1177/1357633X19832713. Epub 2019 Apr 11.
The aim of this study was to assess the impact on health-related quality of life (HRQoL) of a telehealth care solution compared with usual practice of patients with heart failure (HF).
A randomized controlled trial with a telehealth care solution (Telekit) as the intervention (with a focus on self-empowerment achieved by engaging patients in their own illness through self-monitoring) combined with usual care and usual care as the control. The primary outcome was a change in HRQoL as measured by the Short Form-36 (SF-36) questionnaire Physical Component Summary (PCS) score. Secondary outcomes were changes in HRQoL as measured by the SF-36 questionnaire Mental Component Summary (MSC) score and the HF disease-specific questionnaire Kansas City Cardiomyopathy Questionnaire 12 (KCCQ12) score, all of which were assessed from baseline to approximately 12 months' follow-up between the two groups. Outcomes were assessed via unadjusted and adjusted analyses.
At baseline, 299 (145 interventions, 154 controls) patients were enrolled. In the primary analysis ( = 299), the adjusted intervention effects were PCS -0.81 (95% CI -2.7-1.1), MCS 4.66 (95% CI 1.8-7.5) and KCCQ12 3.67 (95% CI -0.7-8.1). Only the change in MCS was statistically significant. An unadjusted analysis replicated the primary analysis. Complete case analyses ( = 193) generally resulted in a lower intervention effect on the PCS score, but the difference remained statistically insignificant.
Only the MCS score was significantly higher in the telehealth care group compared to the control group.ClinicalTrials.gov (NCT02860013), July 28, 2016.
本研究旨在评估远程医疗护理解决方案对心力衰竭(HF)患者健康相关生活质量(HRQoL)的影响与常规护理相比。
这是一项随机对照试验,采用远程医疗护理解决方案(Telekit)作为干预措施(重点是通过自我监测使患者参与自身疾病从而实现自我赋权),并结合常规护理作为对照组。主要结局是采用 36 项简短健康调查问卷(SF-36)生理成分综合评分(PCS)衡量的 HRQoL 变化。次要结局是采用 SF-36 问卷心理成分综合评分(MSC)和心力衰竭特异性问卷堪萨斯城心肌病问卷 12 (KCCQ12)评分衡量的 HRQoL 变化,两组患者在基线至约 12 个月随访期间进行评估。采用未调整和调整后的分析评估结局。
在基线时,共有 299 名(145 名干预组,154 名对照组)患者入组。在主要分析( = 299)中,调整后的干预效果为 PCS -0.81(95%CI-2.7-1.1)、MSC 4.66(95%CI1.8-7.5)和 KCCQ12 3.67(95%CI-0.7-8.1)。只有 MSC 的变化具有统计学意义。未调整分析复制了主要分析。完全案例分析( = 193)通常会使 PCS 评分的干预效果降低,但差异仍无统计学意义。
与对照组相比,远程医疗护理组的 MSC 评分仅显著升高。临床试验.gov(NCT02860013),2016 年 7 月 28 日。