Virtual visits to optimize research trial offerings to heart failure patients

Abstract

BackgroundClinical 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).ObjectivesWe hypothesized that 6MWT and TUG performed virtually would be feasible and comparable to in-person functionality testing for heart failure patients.MethodsThis 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.ResultsOf 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 (P = .45). One-way repeated measures ANOVA found a statistical difference between mean TUG scores (P = .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%).ConclusionVirtual 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.