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

Sponsor
Biofourmis Singapore Pte Ltd. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04191356
Collaborator
Food and Drug Administration (FDA) (U.S. Fed), Mayo Clinic (Other)
150
Enrollment
6
Locations
22.5
Anticipated Duration (Months)
25
Patients Per Site
1.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The Food and Drug Administration (FDA) recognizes the importance of developing patient-centric endpoints that are relevant to patients beyond mortality and hospitalizations. Patients with HF have reduced function capacity and quality of life (QoL) and hence it is imperative to explore interventions that impact endpoints that directly measure how a patient feels or functions on a daily basis.

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. These technologies are able to capture and integrate data from disparate sources from individual patients reflecting their functional status and symptomatology. These data can potentially serve as surrogate endpoints for approval of new HF therapies.

In this study, the investigators will test the feasibility of a novel mobile health monitoring platform to capture patients' physiology, functional capacity and assessment of quality of life.

Condition or DiseaseIntervention/TreatmentPhase

    Detailed Description

    Heart Failure (HF) is a highly prevalent disease that also carries high morbidity and mortality. Improvements in mortality and healthcare utilization, including hospitalizations of HF still remain the gold standard outcomes for HF drug approval. However, it is difficult to improve mortality as the only endpoint due to the variation in the age groups and comorbidities of the population and ineffectiveness to alter all-cause mortality, particularly in patients with heart failure with preserved ejection fraction (HFpEF). Considering these issues, there is a need for exploration of complimentary endpoints. The Food and Drug Administration (FDA) recognizes the importance of developing patient-centric endpoints that are relevant to patients beyond mortality and hospitalizations. Patients with HF have reduced function capacity and quality of life (QoL) and hence it is imperative to explore interventions that impact endpoints that directly measure how a patient feels or functions on a daily basis. 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. Other objective measures of functional status include a 6-minute walk test (6MWT) and potentially measures of activity using implanted or wearable sensors. Patient-reported outcomes (PROMs) can also be used to record and quantify symptoms but are cumbersome and impractical since significant resources are required to contact patients and administer questionnaires. It is also particularly difficult to record these and correlate with physiologic signals in real-time.

    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. These technologies are able to capture and integrate data from disparate sources from individual patients reflecting their functional status and symptomatology. These data can potentially serve as surrogate endpoints for approval of new HF therapies. A novel mobile health platform (BiovitalsHF, developed by Biofourmis) enables continuous acquisition and monitoring of multiple physiologic data (for e.g. electrocardiogram, heart rate, respiration rate, activity intensity, 3-axis accelerometer and sleep) using readily available biosensors (Everion® MD and Apple Watch will be used for this study). The BiovitalsHF smartphone app is capable of capturing patient's physiology, functional capacity (using activity patterns, including guided mobile-based 6MWT) and assessment of QoL through validated PROs.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    150 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    Official Title:
    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)
    Actual Study Start Date :
    Oct 17, 2020
    Anticipated Primary Completion Date :
    Mar 1, 2022
    Anticipated Study Completion Date :
    Sep 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Feasibility of monitoring functional capacity among patients using mobile health monitoring platform [8 weeks]

      • Correlation between physiology and accelerometer data collected from Everion and Apple Watch (ie: heart rate, single lead ecg report) with 6MWT, laboratory (ie: eGFR, troponin, creatinine, NT-proNBP) results, and KCCQ-12 & EQ-5D-5L

    Secondary Outcome Measures

    1. Feasibility of collecting heart rate, single lead ECG report, respiration rate, and other continuous biometric data with KCCQ-12 and EQ-5D-5L using mobile-health monitoring platform [8 weeks]

      Metrics measured: (i) Compliance rate, (ii) Drop-out rate, (iii) mean time worn/day, and (iv) proportion of time worn that device produces reliable data.

    Other Outcome Measures

    1. Percentage of patients on HF GDMT [8 weeks]

      Percentage of patients on beta blocker, ACE/ARN/ or ARNI and MRA Percentage of patients on target dose of GDMT 30-days hospitalization, Clinic visits and ED visits and it's correlation to patients on HF GDMT and target dose of GDMT

    2. Satisfaction with the mobile device(s) and mobile health monitoring platform using BiovitalsHF user experience questionaire to understand subject's perception and acceptance of Biofourmis' platforms [6 months]

      BiovitalsHF is a 18-question survey on a scale of 1-5 where 1 represent the worst experience and 5 represent the best experience.

    3. Evaluating 6-month mortality rate [6 months]

      Describe the number of deaths in 6 months

    4. Evaluating number of emergency visits at 6 months [6 months]

      Count the number emergency visit at 6 months

    5. Evaluating number of hospitalizations at 6 months [6 months]

      Count the number hospitalization at 6 months

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. Age ≥ 21 to ≤ 85 years at signing of informed consent.

    2. Diagnosis of heart failure, defined as requiring pharmacologic treatment for heart failure, with NYHA class II to class III at most recent screening assessment

    3. Screening within 30 days after hospitalization for heart failure - either as a primary or secondary diagnosis.

    4. History of (within the past 6 months) or current use of diuretics.

    5. 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:

    Disease Related

    1. Acute coronary syndrome (ST-elevation myocardial infarction, non-ST-elevation myocardial infarction, unstable angina) stroke, or transient ischemic attack, major cardiac surgery, percutaneous coronary intervention, or valvuloplasty within the 30 days prior to screening.

    2. Uncontrolled hypertension defined as sitting systolic blood pressure (SBP) 3 180 mm Hg or diastolic BP (DBP) 3 110 mm Hg.

    3. Untreated severe ventricular arrhythmia (e.g., ventricular tachycardia or ventricular fibrillation).

    4. Symptomatic bradycardia or second or third-degree heart block without a pacemaker

    Other Medical Conditions

    1. Malignancy except non-melanoma skin cancers, cervical or breast ductal carcinoma in situ within the last 5 years

    2. Hospitalization with any pathology that may meaningfully interfere with functional tolerance, cardiopulmonary capacity or mobility within the 30 days prior to screening.

    3. Estimated glomerular filtration rate (eGFR) < 20 mL/min/1.73 m2 or receiving dialysis at screening.

    Prior/Concomitant Medication

    1. Routinely scheduled outpatient intravenous infusions for heart failure (e.g. inotropes, vasodilators [e.g. nesiritide], diuretics) or routinely scheduled ultrafiltration.

    2. Currently receiving treatment or procedure in another investigational device or drug study.

    Other Exclusions

    1. Likely to receive during the duration of the study, in the opinion of the investigator, planned revascularization, implantation of ICD or CRT, ventricular assist device, continuous or intermittent inotropic therapy, hospice care, or cardiac transplant.

    2. Implantable cardioverter defibrillator or initiation of cardiac resynchronization therapy (CRT) (with/without implantable cardioverter defibrillator) within 30 days prior to enrollment.

    3. Recipient of any major organ transplant (e.g. lung, liver, heart, bone marrow, kidney).

    4. Less than 4 months prior Interventional Clinical Study participation.

    5. Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (e.g. Clinical Outcome Assessments) to the best of the subject and investigator's knowledge.

    6. History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.

    7. Any individuals that are lacking the ability to consent.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Mayo ClinicJacksonvilleFloridaUnited States32224
    2National University HospitalSingaporeSingapore119074
    3National Heart Centre SingaporeSingaporeSingapore169609
    4Tan Tock Seng HospitalSingaporeSingapore308433
    5Changi General HospitalSingaporeSingapore529889
    6Khoo Teck Puat HospitalSingaporeSingapore768828

    Sponsors and Collaborators

    • Biofourmis Singapore Pte Ltd.
    • Food and Drug Administration (FDA)
    • Mayo Clinic

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Biofourmis Singapore Pte Ltd.
    ClinicalTrials.gov Identifier:
    NCT04191356
    Other Study ID Numbers:
    • CT003
    First Posted:
    Dec 9, 2019
    Last Update Posted:
    Oct 7, 2021
    Last Verified:
    Sep 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 7, 2021