Evaluating Mobile Health Tool Use for Capturing Patient-centered Outcomes Measures in HF Patients
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 Disease | Intervention/Treatment | Phase |
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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
Outcome Measures
Primary Outcome Measures
- 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
- Evaluate the feasibility of collecting continuous, biometrics data and ePRO's 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
- 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
- Satisfaction with the mobile device(s) and mobile health monitoring platform using BiovitalsHF user experience questionnaire to understand subject's perception and acceptance of Biofourmis' platforms [8 weeks]
Patient experience response.
- Evaluate the association of ECG-related signals to progression of HF disease [8 weeks]
Correlation of changes in ECG signals with functional status and clinical outcomes. ECG signals: (i) QRS duration, (ii) QT interval, (iii) QTc interval
- Evaluate the association of vitals-related signals to progression of HF disease [8 weeks]
Correlation of changes in vital signals with functional status and clinical outcomes. Vital signals: (i) Respiratory rate during 6MWT, (ii) Heart rate during 6MWT, (iii) Heart rate recovery after 6MWT, (iv) Resting heart rate, (v) Resting heart rate variability
- Evaluate the association of voice-related signals to progression of HF disease. [8 weeks]
Correlation of changes in voice signals with functional status and clinical outcomes Voice signals: (i) Mel Cepstrum representation, (ii) Pitch and formant measures, (iii) Jitter, (iv) Shimmer, (v) Loudness, (vi) Frequency-domain features
Eligibility Criteria
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.
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Age more than 21 to less than 85 years at signing of informed consent.
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Diagnosis of heart failure, defined as requiring pharmacologic treatment for heart failure, with NYHA class I to class III at most recent screening assessment
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Screening within 30 days after Clinic Visit or hospitalization for heart failure - either as a primary or secondary diagnosis.
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History of (within the past 6 months) or current use of diuretics.
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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
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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.
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Uncontrolled hypertension defined as sitting systolic blood pressure (SBP) more than or equal to 180 mm Hg or diastolic BP (DBP)more than or equal to 110 mm Hg.
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Untreated severe ventricular arrhythmia (e.g., ventricular tachycardia or ventricular fibrillation).
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Symptomatic bradycardia or second or third-degree heart block without a pacemaker
Other Medical Conditions
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Malignancy except non-melanoma skin cancers, cervical or breast ductal carcinoma in situ within the last 5 years
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Hospitalization with any pathology that may meaningfully interfere with functional tolerance, cardiopulmonary capacity or mobility within the 30 days prior to screening.
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Estimated glomerular filtration rate (eGFR) < 20 mL/min/1.73 m2 or receiving dialysis at screening.
Prior/Concomitant Medication
- Currently receiving treatment or procedure in another investigational device or drug study.
Other Exclusions
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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.
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Implantable cardioverter defibrillator or initiation of cardiac resynchronization therapy (CRT) (with/without implantable cardioverter defibrillator) within 30 days prior to enrollment.
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Recipient of any major organ transplant (e.g. lung, liver, heart, bone marrow, kidney).
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Less than 4 months prior Interventional Clinical Study participation.
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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.
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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.
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Any individuals that are lacking the ability to consent.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mayo Clinic | Jacksonville | Florida | United States | 32224 |
| 2 | National University Hospital | Singapore | Singapore | 119074 | |
| 3 | National Heart Centre Singapore | Singapore | Singapore | 169609 | |
| 4 | Tan Tock Seng Hospital | Singapore | Singapore | 308433 | |
| 5 | Changi General Hospital | Singapore | Singapore | 529889 | |
| 6 | Khoo Teck Puat Hospital | Singapore | Singapore | 768828 |
Sponsors and Collaborators
- Biofourmis Singapore Pte Ltd.
- Food and Drug Administration (FDA)
- Mayo Clinic
Investigators
- Study Chair: Maulik Majmudar, M.D., Biofourmis Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
- Butler J, Hamo CE, Udelson JE, Pitt B, Yancy C, Shah SJ, Desvigne-Nickens P, Bernstein HS, Clark RL, Depre C, Dinh W, Hamer A, Kay-Mugford P, Kramer F, Lefkowitz M, Lewis K, Maya J, Maybaum S, Patel MJ, Pollack PS, Roessig L, Rotman S, Salsali A, Sims JJ, Senni M, Rosano G, Dunnmon P, Stockbridge N, Anker SD, Zile MR, Gheorghiade M. Exploring New Endpoints for Patients With Heart Failure With Preserved Ejection Fraction. Circ Heart Fail. 2016 Nov;9(11). pii: e003358.
- Campbell RT, Jhund PS, Castagno D, Hawkins NM, Petrie MC, McMurray JJ. What have we learned about patients with heart failure and preserved ejection fraction from DIG-PEF, CHARM-preserved, and I-PRESERVE? J Am Coll Cardiol. 2012 Dec 11;60(23):2349-56. doi: 10.1016/j.jacc.2012.04.064. Epub 2012 Nov 7. Review.
- Palau P, Núñez E, Domínguez E, Sanchis J, Núñez J. Physical therapy in heart failure with preserved ejection fraction: A systematic review. Eur J Prev Cardiol. 2016 Jan;23(1):4-13. doi: 10.1177/2047487314562740. Epub 2014 Dec 8. Review.
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