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

NCT04191356 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 67

Last updated 2023-10-05

No results posted yet for this study

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

Sponsors & Collaborators

  • Food and Drug Administration (FDA)

    collaborator FED

  • Mayo Clinic

    collaborator OTHER

  • Biofourmis Singapore Pte Ltd.

    lead INDUSTRY

Principal Investigators

  • Maulik Majmudar, M.D. · Biofourmis Inc.

Eligibility

Min Age
21 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-17
Primary Completion
2023-02-06
Completion
2023-02-06

Countries

  • United States
  • Singapore

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04191356 on ClinicalTrials.gov