NCT04191356

Evaluating Mobile Health Tool Use for Capturing Patient-centered Outcomes Measures in HF Patients

An Observational, Multicentre Study to Evaluate the Feasibility of a Novel Mobile Health Monitoring Platform to Capture Patient-centered Outcomes Measures Among Patients With Heart Failure (HF)

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 67 (actual)
• Sponsor: Biofourmis Singapore Pte Ltd. · Industry
• Sex: All
• Age: 21 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Heart Failure (HF) is a highly prevalent disease that also carries high morbidity and mortality. The Food and Drug Administration (FDA) recognizes the importance of developing patient-centric endpoints that are relevant to patients beyond mortality and hospitalizations. Although functional status can be objectively measured by peak exercise oxygen consumption, it is difficult and impractical to implement in large clinical studies, especially in an ambulatory real-world setting. Recently, new mobile health technologies have emerged as clinical tools and offer an opportunity to overcome these challenges in measuring functional capacity and recording symptoms. The goal of this observational study is to evaluate the feasibility of monitoring functional capacity among patients with heart failure (HF) using mobile health monitoring platforms. Everion® and Apple Watch Series 4 and above will be used for this study. The BiovitalsHF® mobile app can capture patients' key cardiopulmonary physiological parameters, functional capacity (using activity patterns, including guided mobile-based 6MWT, audio recording) and assessment of QoL through validated PROs.

Conditions

• Heart Failure

Timeline

• Start date: 2020-10-17
• Primary completion: 2023-02-06
• Completion: 2023-02-06
• First posted: 2019-12-09
• Last updated: 2023-10-05

Locations

6 sites across 2 countries: United States, Singapore