Virtual Visits to Optimize Research Trial Offerings to Heart Failure Patients

Abstract

Clinical trials are crucial for development of new treatments that impact patient outcomes. A pilot study was designed to explore the use of virtual visits to collect functional information on patients living with heart failure. Assessments used in HF trials are the six-minute hallway walk test (6MWT) and timed-up and go test (TUG). We hypothesized virtual 6MWT and TUG would be non-inferior to the patient's baseline, in-person testing. Patients were enrolled in an outpatient setting. Informed consent was obtained. Baseline consisted of NYHA assessment, surveys (EQ-5D-5L, KCCQ, FIFE & Mini Cog), TUG and 6MWT. Patients were issued supplies to set up TUG/6MWT course at home. Follow-up video visits occured 7 days and 14 days [+/- 3 days] post-baseline. Surveys (EQ-5D-5L, KCCQ & Frailty Index), TUG and 6MWT were completed. Study staff reviewed 6MWT/TUG course set up for accuracy. Patients were supervised for the entirety of their 6MWT/TUG. Of the 94 patients enrolled, 74 patients completed all 6MWT assessments. Patient characteristics were described using mean and SD. One-way repeated measures ANOVA compared mean differences of in-person and virtual 6MWT/TUG. 6MWT scores at baseline, Day 7 and Day 14 were 1052.3 ft., 1107.6 ft., and 1080.3 ft., respectively. One-way repeated measures ANOVA found no statistical difference between mean in-person and virtual 6MWT (p = 0.45). Mean TUG scores at baseline, Day 7 and Day 14 were 9.3 s., 10.83s, and 9.7s., respectively. One-way repeated measures ANOVA found a statistical difference between mean TUG scores (p = 0.03). TUG results show significant outliers potentially influenced by patient symptoms (SOB, fatigue). Patient acceptance was assessed by exit interview. Patients were comfortable with the use of virtual visits (56%), would be willing to participate in research studies through telemedicine (98.7%) and found the act of completing a study via virtual visit to be not difficult (77.3%). Virtual administration of the 6MWT was shown to be non-inferior to in-person administration. This approach could be adopted by industry-sponsored and investigator initiated research studies in heart failure cohorts. Increasing clinical trial enrollment barriers will improve patient care by including a more diverse patient population in study enrollment and decrease study follow up attrition rates.