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)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- Biofourmis Singapore Pte Ltd.
- Enrollment
- 67
- Locations
- 6
- Primary Endpoint
- Feasibility of monitoring functional capacity among patients using mobile health monitoring platform
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects are eligible to be included in the study only if all the following criteria apply:
- •Subjects has provided informed consent prior to initiation of any study specific activities/procedures.
- •Age more than 21 to less than 85 years at signing of informed consent.
- •Diagnosis of heart failure, defined as requiring pharmacologic treatment for heart failure, with NYHA class I to class III at most recent screening assessment
- •Screening within 30 days after Clinic Visit or hospitalization for heart failure - either as a primary or secondary diagnosis.
- •History of (within the past 6 months) or current use of diuretics.
- •HF patient who is willing to comply with study restrictions including Everion device management (wearing and charging the device), Apple watch Series 4 and above device management (wearing and charging the device) and BiovitalsHF Patient App Management (pairing Everion device and Apple watch Series 4 and above and BiovitalsHF Patient App, and carrying the smartphone for answering questionnaires and data reporting)
- •Exclusion Criteria
- •Subjects are excluded from the study if any of the following criteria apply:
- •Disease Related
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Feasibility of monitoring functional capacity among patients using mobile health monitoring platform
Time Frame: 8 weeks
Measurement of correlation between physiology and accelerometer (activity) data/derivatives with: * 6MWT * Patient-reported KCCQ * Lab results
Secondary Outcomes
- Drop-out rate(8 weeks)
- Compliance rate(8 weeks)
- Proportion of time worn that device produces reliable data(8 weeks)
- Mean time worn/day(8 weeks)