Moennich Laurie Ann, Bittel Barbara, Estep Jerry D
Heart, Vascular, and Thoracic Institute Research and Registries, Cleveland Clinic, Cleveland, Ohio.
Department of Cardiovascular Medicine, Heart, Vascular, and Thoracic Institute, Cleveland Clinic, Cleveland, Ohio.
Cardiovasc Digit Health J. 2021 Nov 18;3(1):40-45. doi: 10.1016/j.cvdhj.2021.10.006. eCollection 2022 Feb.
Clinical trials are crucial for development of new treatments that impact outcomes. Assessments used in heart failure trials include the 6-minute hallway walk test (6MWT) and timed up and go test (TUG).
We hypothesized that 6MWT and TUG performed virtually would be feasible and comparable to in-person functionality testing for heart failure patients.
This pilot study explored the use of virtual visits to collect functional information on patients living with heart failure. Patients were enrolled in an outpatient setting. Informed consent was obtained. Baseline testing consisted of patient-reported New York Hospital Association class, quality-of-life surveys (EQ-5D-5L, Kansas City Cardiomyopathy Questionnaire [KCCQ], Frailty Index for Elders), and cognitive assessments (Mini-Cog). Patients also completed an in-person TUG and 6MWT at baseline. Patients were issued supplies to set up TUG/6MWT courses at home. Follow-up video visits occurred 7 days and 14 days (± 3 days) postbaseline. Surveys (EQ-5D-5L, KCCQ, Frailty Index), TUG, and 6MWT were completed. Study staff reviewed 6MWT/TUG course set-up for accuracy and supervised patients during testing.
Of the 94 patients enrolled, 74 patients completed all 6MWT assessments. One-way repeated measures ANOVA found no statistical difference between mean in-person and virtual 6MWT ( = .45). One-way repeated measures ANOVA found a statistical difference between mean TUG scores ( = .03). Patients were comfortable with the use of virtual visits (56%), would participate in research studies through telemedicine (98.7%), and found completing a virtual research visit to be not difficult (77.3%).
Virtual administration of the 6MWT was shown to be feasible and acceptable to heart failure patients as compared to in-person functionality testing. This approach could be implemented into clinical care pathways for evaluation of heart failure patients, as well as adopted by industry-sponsored and investigator-initiated research studies in heart failure cohorts for data collection.
临床试验对于开发影响治疗结果的新疗法至关重要。心力衰竭试验中使用的评估方法包括6分钟走廊步行试验（6MWT）和计时起立行走试验（TUG）。
我们假设虚拟进行的6MWT和TUG对于心力衰竭患者是可行的，并且与现场功能测试具有可比性。
这项试点研究探讨了使用虚拟就诊来收集心力衰竭患者的功能信息。患者在门诊环境中入组。获得了知情同意。基线测试包括患者报告的纽约医院协会分级、生活质量调查（EQ-5D-5L、堪萨斯城心肌病问卷[KCCQ]、老年人衰弱指数）和认知评估（简易认知评估量表）。患者在基线时还完成了现场TUG和6MWT。为患者发放了在家中设置TUG/6MWT课程的用品。在基线后7天和14天（±3天）进行随访视频就诊。完成了调查（EQ-5D-5L、KCCQ、衰弱指数）、TUG和6MWT。研究人员检查了6MWT/TUG课程设置的准确性，并在测试期间监督患者。
在入组的94例患者中，74例患者完成了所有6MWT评估。单向重复测量方差分析发现，现场和虚拟6MWT的平均值之间无统计学差异（P = 0.45）。单向重复测量方差分析发现，TUG平均得分之间存在统计学差异（P = 0.03）。患者对使用虚拟就诊感到满意（56%），愿意通过远程医疗参与研究（98.7%），并且认为完成虚拟研究就诊并不困难（77.3%）。
与现场功能测试相比，虚拟进行6MWT对心力衰竭患者是可行且可接受的。这种方法可以纳入心力衰竭患者评估的临床护理路径，也可被行业资助和研究者发起的心力衰竭队列研究采用以进行数据收集。
