Congestive Heart Failure
Conditions
Keywords
Digital Health
Brief summary
The purpose of this study is to determine the efficacy of three novel digital health technologies versus usual care in the management of congestive heart failure, as assessed by a primary outcome of improvement in quality of life, and a variety of secondary outcomes that include metrics measuring patient and provider satisfaction, clinical efficiency, and patient outcomes.
Detailed description
Heart failure is the most common cause of mortality and morbidity in the United States and in Western Europe. However, patient etiology and prognosis varies considerably, and guidance about how to best treat patients has relied on large clinical trials that only include snapshots of the syndrome (at the time the patient interaction with the healthcare system). It remains to be seen whether behavioral interventions can improve patient engagement, increase self-management of the conditions, and thus improve overall clinical outcomes. Digital health technologies have a great potential to streamline and optimize the clinical management of heart failure. Such technologies can take the form of mobile applications or wearable devices that may provide both patients and providers with valuable real-time information about patient status and cardiovascular health, provide automated patient-tailored coaching and motivational tools, or a mix of both. Integration of these technologies into healthcare systems may allow for genuine engagement of the patient in their own care and management of their disease and/or enhance clinical decision making. To date, no prior study has comprehensively examined the ability of digital heath technologies to improve self-management of heart failure or subsequent clinical outcomes. This study is an unblinded, 4-arm, parallel group randomized controlled trial to measure the efficacy of four digital health technologies in improving the management of care and quality of life of patients with congestive heart failure (CHF). Patients actively managed by one of Yale New Haven Hospital's heart failure-based clinics will be eligible for this study and approached for consent. Enrolled subjects will be randomized to one of four groups: a control (usual care) arm, or to one of three intervention arms, each of which assesses one of three digital health technologies. These technologies are: * BodyPort: A data-driven smart scale that provides enhanced cardiac monitoring and risk assessment data. * Noom: A live, data-driven coaching application providing personalized diet and weight management. * Conversa: An automated conversational platform providing patient motivation and educational tools for CHF management. Patients will be enrolled in the study for 6 months. The first three months will typically involve active clinic management and will be the point of our primary outcome assessment, while the final three months will assess stability of effect on patient care and outcomes. The primary outcome is the rate of improvement in quality of life after 90 days post-enrollment, as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ). A variety of prespecified secondary outcomes will be measured to determine effects on patient outcomes, quality of care, clinical efficiency, and provider and patient satisfaction with the product.
Interventions
DEVICEBodyPort
Patients will receive BodyPort, a smart scale that provides advanced cardiac monitoring.
OTHERNoom
Patients will receive a subscription to use Noom, a personalized diet and weight management application.
OTHERConversa
patients will receive a subscription to use Conversa, a personalized automated coaching and motivational application.
Sponsors
Boehringer Ingelheim
ZS
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* Adults greater than or equal to 18 and less than 80 years of age * Enrolled in one of Yale New Haven Hospital's Disease Management or Heart Failure-focused cardiology clinics * Diagnosed with congestive heart failure (preserved or reduced ejection fraction with or without diabetes)
Exclusion criteria
* Class IV heart failure * Stage 4 or end stage renal disease (eGFR \< 30) * Recipient of a heart transplant of ventricular assist device * Under hospice care * Dementia * Incarceration * Pregnancy * Currently homeless or residing in an unstable living situation (i.e., transitional housing, rehab facility, etc.) * Inability to consent * Currently enrolled in a study investigating a digital health product or technology * Life expectancy of less than 6 months as determined by clinical judgement of primary treating physician * weight greater than 400 pounds * unable to stand straight up for 30 seconds without assistance, such as from a cane, walker, or wall. * non-English speaking
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Quality of Life at 90 Days Post Enrollment | Day 90 after enrollment | Assessed by the change in score of the Kansas City Cardiomyopathy Questionnaire (KCCQ) survey between baseline scoring (at enrollment) and at 90 days post-enrollment. This survey is a 23 item self-administered instrument used to quantify a patient's perception of health status. For each domain reported, an overall summary scored is derived and transformed to a score range of 0-100. The Total Symptom score is the mean of the Symptom Frequency and Symptom Burden scores. The Overall Summary Score is the mean of the Physical Limitation, Total Symptom, Quality of Life and Social Limitation Scores. The Clinical Summary score is the mean of the Physical Limitation and Total Symptom scores. All KCCQ scores are summarized in 25-point ranges, where scores represent health status as follows: 0 to 24: very poor to poor; 25 to 49: poor to fair; 50 to 74: fair to good; and 75 to 100: good to excellent. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Hospital Admission at 90 Days Post Enrollment | 90 days post enrollment | Via medical record review. Number of patients with a hospital admission between enrollment to day 90 post enrollment. |
| Number of Participants With Hospital Admission at 180 Days Post Enrollment | 180 days post enrollment | Via medical record review. This measure is calculated as the number of participants with a hospital admission from day 90 to day 180 post enrollment. |
| Prescribing of Guideline-directed Medical Therapy | 90 days post enrollment | Documented prescription or change in dosing of any one of the following medication classes: beta blockers, ACEi/ARBs, and/or spironolactone; assessed via Surescripts data collection. |
| Number of Subjects Using Guideline-directed Medical Therapy at 90 Days Post Enrollment | 90 days post enrollment | Number of patients having documented prescription of all of the following medication classes between enrollment and day 90 post enrollment: beta blockers, angiotensin-converting enzyme inhibitors (ACEi)/angiotensin receptor blockers (ARBs)/angiotensin receptor-neprilysin inhibitors (ARNI), sodium/glucose cotransporter-2 inhibitors (SGLT2i) and aldosterone receptor antagonists (MRAs); assessed via Surescripts data collection. |
| Number of Subjects Using Guideline-directed Medical Therapy at 180 Days Post Enrollment | 180 days post enrollment | Number of patients having documented prescription of all of the following medication classes between day 90 post enrollment and day 180 post enrollment: beta blockers, angiotensin-converting enzyme inhibitors (ACEi)/angiotensin receptor blockers (ARBs)/angiotensin receptor-neprilysin inhibitors (ARNI), sodium/glucose cotransporter-2 inhibitors (SGLT2i) and aldosterone receptor antagonists (MRAs); assessed via Surescripts data collection. |
| Number of Participants With Emergency Department (ED) Visits at 90 Days Post Enrollment | 90 days post enrollment | Via medical record review. Number of participants with an emergency department visit between enrollment and day 90 post enrollment. |
| Number of Participants With Emergency Department Visits at 180 Days Post Enrollment | 180 days post enrollment | Via medical record review. Number of participants with an emergency department visit between day 90 and day 180 post enrollment. |
| Number of Participants With Acute Kidney Injury (AKI) Development at 90 Days Post Enrollment | 90 days post enrollment | Via medical record review, defined as an increase in serum creatinine by 50% over baseline (pre-enrollment creatinine) at any point between enrollment day 90 post enrollment. |
| Number of Participants With Acute Kidney Injury (AKI) Development at 180 Days Post Enrollment | 180 days post enrollment | Via medical record review, defined as an increase in serum creatinine by 50% over baseline (pre-enrollment creatinine) at any point between day 90 and day 180 post enrollment. |
| Mortality Rate at 90 Days Post Enrollment | 90 days post enrollment | Via medical record review. Number of deaths between enrollment and 90 days post enrollment. |
| Mortality Rates at 180 Days Post Enrollment | 180 days post enrollment | Via medical record review. Number of deaths between day 90 and day 180 post enrollment. |
| Change in Quality of Life at 180 Days Post Enrollment | 180 days post enrollment | Assessed by the change in score of the Kansas City Cardiomyopathy Questionnaire (KCCQ) survey between day 90 post enrollment and at day 180 post enrollment. This survey is a 23 item self-administered instrument used to quantify a patient's perception of health status. For each domain reported, an overall summary scored is derived and transformed to a score range of 0-100. The Total Symptom score is the mean of the Symptom Frequency and Symptom Burden scores. The Overall Summary Score is the mean of the Physical Limitation, Total Symptom, Quality of Life and Social Limitation Scores. The Clinical Summary score is the mean of the Physical Limitation and Total Symptom scores. All KCCQ scores are summarized in 25-point ranges, where scores represent health status as follows: 0 to 24: very poor to poor; 25 to 49: poor to fair; 50 to 74: fair to good; and 75 to 100: good to excellent. |
| Number of In-person and Remote Clinic Visits at 90 Days Post Enrollment | 90 days post enrollment | Via medical record review. Number of visits between enrollment and 90 days post enrollment. |
| Number of In-person and Remote Clinic Visits at 180 Days Post Enrollment | 180 days post enrollment | Via medical record review. Number of visits between day 90 and day 180 post enrollment. |
| Number of Remote Device Checks by Providers at 90 Days Post Enrollment | 90 days post enrollment | Via medical record review |
| Number of Remote Device Checks by Providers at 180 Days Post Enrollment | 180 days post enrollment | Via medical record review |
| Number of Phone Calls Between Provider and Participant at 90 Days Post Enrollment | 90 days post enrollment | Via medical record review of telephone logs between enrollment and day 90 post enrollment. |
| Number of Phone Calls Between Provider and Participant at 180 Days Post Enrollment | 180 days post enrollment | Via medical record review of telephone logs |
| Average Time Devoted by Provider to Patient Care | 90 days post enrollment | Via medical record review of chart openings per patient |
| Number of Subjects Who Complete on Boarding and Baseline Assessments | Within one week of consent | Collected from patient enrollment platform |
| Number of Subjects Who Complete Digital Health Product Set up | 90 days post enrollment | Assessed as number of subjects who used device at least once during their duration in the study, up to 90 days post enrollment. |
| Number of Weekly Interactions With the Device | 90 days post enrollment | Information collected from device metrics to assess frequency of use |
| Average Number of Daily Interactions With the Device | 90 days post enrollment | Information collected from device metric to assess frequency of use |
| Number of Participants With at Least One Clinic No-show at 90 Days Post Enrollment | 90 days post enrollment | Via medical record review; number of participants with at least one clinic no show between enrollment and day 90 post enrollment. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Patients will receive usual care and no digital health device. | 44 |
| BodyPort Patients will receive the BodyPort device.
BodyPort: Patients will receive BodyPort, a smart scale that provides advanced cardiac monitoring. | 46 |
| Noom Patients will receive a subscription to the Noom platform.
Noom: Patients will receive a subscription to use Noom, a personalized diet and weight management application. | 46 |
| Conversa Patients will receive a subscription to the Conversa platform.
Conversa: patients will receive a subscription to use Conversa, a personalized automated coaching and motivational application. | 46 |
| Total | 182 |
Baseline characteristics
| Characteristic | BodyPort | Total | Conversa | Control | Noom |
|---|---|---|---|---|---|
| Age, Continuous | 59 years | 61 years | 62.5 years | 59 years | 62 years |
| Alanine transaminase (ALT) | 22 U/L | 25 U/L | 25 U/L | 31 U/L | 24 U/L |
| Aspartate aminotransferase (AST) | 25 U/L | 26 U/L | 28 U/L | 27 U/L | 25 U/L |
| Brain Natriuretic Peptide (BNP) | 876.5 pg/mL | 858 pg/mL | 914.2 pg/mL | 995.5 pg/mL | 737.5 pg/mL |
| Cardiac Device CardioMEMS | 2 Participants | 9 Participants | 4 Participants | 1 Participants | 2 Participants |
| Cardiac Device Implantable cardioverter defibrillator (ICD) | 16 Participants | 61 Participants | 19 Participants | 11 Participants | 15 Participants |
| Cardiac Device No device | 24 Participants | 99 Participants | 25 Participants | 27 Participants | 23 Participants |
| Cardiac Device Other | 0 Participants | 4 Participants | 1 Participants | 0 Participants | 3 Participants |
| Cardiac Device Pacemaker | 7 Participants | 19 Participants | 1 Participants | 5 Participants | 6 Participants |
| Comorbidities Chronic Kidney Disease (CKD) | 12 Participants | 38 Participants | 11 Participants | 6 Participants | 9 Participants |
| Comorbidities Chronic obstructive pulmonary disease (COPD) | 10 Participants | 30 Participants | 7 Participants | 4 Participants | 9 Participants |
| Comorbidities Coronary artery disease (CAD) | 21 Participants | 58 Participants | 13 Participants | 11 Participants | 13 Participants |
| Comorbidities Depression | 14 Participants | 36 Participants | 7 Participants | 7 Participants | 8 Participants |
| Comorbidities Diabetes Mellitus | 21 Participants | 76 Participants | 19 Participants | 17 Participants | 19 Participants |
| Comorbidities Hyperlipidemia | 17 Participants | 68 Participants | 12 Participants | 18 Participants | 21 Participants |
| Comorbidities Hypertension | 35 Participants | 131 Participants | 36 Participants | 23 Participants | 37 Participants |
| Comorbidities Liver Disease | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Comorbidities Malignancy | 3 Participants | 12 Participants | 4 Participants | 0 Participants | 5 Participants |
| Comorbidities Obesity | 18 Participants | 70 Participants | 17 Participants | 17 Participants | 18 Participants |
| Creatinine | 1.18 mg/dL | 1.1 mg/dL | 1.09 mg/dL | 1.08 mg/dL | 1.15 mg/dL |
| Ejection Fraction, median | 29.5 Percent of ventricular ejection | 36 Percent of ventricular ejection | 40 Percent of ventricular ejection | 32 Percent of ventricular ejection | 43.5 Percent of ventricular ejection |
| Estimated Glomerular Filtration Rate (eGFR) | 59 mL/min/1.73m2 | 60 mL/min/1.73m2 | 60 mL/min/1.73m2 | 60 mL/min/1.73m2 | 60 mL/min/1.73m2 |
| Heart Failure Classification Heart failure with preserved ejection fraction (HFpEF) | 13 Participants | 54 Participants | 17 Participants | 8 Participants | 16 Participants |
| Heart Failure Classification (Heart failure with reduced ejection fraction HFrEF) | 33 Participants | 128 Participants | 29 Participants | 36 Participants | 30 Participants |
| Hemoglobin | 12.7 g/dL | 12.7 g/dL | 12.8 g/dL | 12.7 g/dL | 11.9 g/dL |
| Insurance Coverage Commericial | 23 Participants | 92 Participants | 26 Participants | 17 Participants | 26 Participants |
| Insurance Coverage Medicaid | 15 Participants | 47 Participants | 6 Participants | 14 Participants | 12 Participants |
| Insurance Coverage Medicare | 7 Participants | 39 Participants | 12 Participants | 12 Participants | 8 Participants |
| Insurance Coverage Uninsured | 1 Participants | 4 Participants | 2 Participants | 1 Participants | 0 Participants |
| International Normalized Ratio (INR) | 1.1 Ratio | 1.1 Ratio | 1.1 Ratio | 1.1 Ratio | 1.1 Ratio |
| Medications ACEi/ARB/ARNI | 35 Participants | 130 Participants | 33 Participants | 34 Participants | 28 Participants |
| Medications Beta Blocker | 40 Participants | 164 Participants | 42 Participants | 41 Participants | 41 Participants |
| Medications MRA | 22 Participants | 92 Participants | 21 Participants | 23 Participants | 26 Participants |
| Medications SGLT2i | 10 Participants | 53 Participants | 14 Participants | 14 Participants | 15 Participants |
| New York Heart Association (NYHA) classification Class I | 2 Participants | 11 Participants | 4 Participants | 3 Participants | 2 Participants |
| New York Heart Association (NYHA) classification Class II | 12 Participants | 54 Participants | 13 Participants | 17 Participants | 12 Participants |
| New York Heart Association (NYHA) classification Class III | 32 Participants | 103 Participants | 22 Participants | 19 Participants | 30 Participants |
| New York Heart Association (NYHA) classification Unknown | 0 Participants | 14 Participants | 7 Participants | 5 Participants | 2 Participants |
| Partial Thromboplastin Time (PTT) | 25.6 seconds | 27.2 seconds | 27.5 seconds | 30.8 seconds | 27.1 seconds |
| Platelet count | 261.5 10^3 cells/µL | 234 10^3 cells/µL | 230 10^3 cells/µL | 234 10^3 cells/µL | 218 10^3 cells/µL |
| Potassium | 4.2 mmol/L | 4.3 mmol/L | 4.4 mmol/L | 4.3 mmol/L | 4.4 mmol/L |
| Prothrombin time (PT) | 11.9 seconds | 11.9 seconds | 11.7 seconds | 11.3 seconds | 12.1 seconds |
| Race/Ethnicity, Customized Asian | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Hispanic | 4 Participants | 14 Participants | 4 Participants | 5 Participants | 1 Participants |
| Race/Ethnicity, Customized Non-hispanic black | 12 Participants | 61 Participants | 17 Participants | 14 Participants | 18 Participants |
| Race/Ethnicity, Customized Non-hispanic white | 30 Participants | 106 Participants | 25 Participants | 24 Participants | 27 Participants |
| Sex: Female, Male Female | 19 Participants | 69 Participants | 16 Participants | 13 Participants | 21 Participants |
| Sex: Female, Male Male | 27 Participants | 113 Participants | 30 Participants | 31 Participants | 25 Participants |
| Total Bilirubin | 0.3 Mg/dL | 0.5 Mg/dL | 0.4 Mg/dL | 0.5 Mg/dL | 0.5 Mg/dL |
| White Blood Cell (WBC) Count | 7 10^3 cells/µL | 7.1 10^3 cells/µL | 7.5 10^3 cells/µL | 7.1 10^3 cells/µL | 6.9 10^3 cells/µL |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 44 | 2 / 46 | 0 / 46 | 2 / 46 |
| other Total, other adverse events | 0 / 44 | 0 / 46 | 0 / 46 | 0 / 46 |
| serious Total, serious adverse events | 0 / 44 | 0 / 46 | 0 / 46 | 0 / 46 |
Outcome results
Primary
Change in Quality of Life at 90 Days Post Enrollment
Assessed by the change in score of the Kansas City Cardiomyopathy Questionnaire (KCCQ) survey between baseline scoring (at enrollment) and at 90 days post-enrollment. This survey is a 23 item self-administered instrument used to quantify a patient's perception of health status. For each domain reported, an overall summary scored is derived and transformed to a score range of 0-100. The Total Symptom score is the mean of the Symptom Frequency and Symptom Burden scores. The Overall Summary Score is the mean of the Physical Limitation, Total Symptom, Quality of Life and Social Limitation Scores. The Clinical Summary score is the mean of the Physical Limitation and Total Symptom scores. All KCCQ scores are summarized in 25-point ranges, where scores represent health status as follows: 0 to 24: very poor to poor; 25 to 49: poor to fair; 50 to 74: fair to good; and 75 to 100: good to excellent.
Time frame: Day 90 after enrollment
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Control | Change in Quality of Life at 90 Days Post Enrollment | Physical Limitation | -4.2 Scores on a scale (difference) |
| Control | Change in Quality of Life at 90 Days Post Enrollment | Symptom Burden | 0 Scores on a scale (difference) |
| Control | Change in Quality of Life at 90 Days Post Enrollment | Overall Summary Score | 0.3 Scores on a scale (difference) |
| Control | Change in Quality of Life at 90 Days Post Enrollment | Self-Efficacy | 0 Scores on a scale (difference) |
| Control | Change in Quality of Life at 90 Days Post Enrollment | Total Symptom Score | -1 Scores on a scale (difference) |
| Control | Change in Quality of Life at 90 Days Post Enrollment | Clinical Summary Score | -3.1 Scores on a scale (difference) |
| Control | Change in Quality of Life at 90 Days Post Enrollment | Social Limitation | 0 Scores on a scale (difference) |
| Control | Change in Quality of Life at 90 Days Post Enrollment | Symptom Frequency | -2.1 Scores on a scale (difference) |
| Control | Change in Quality of Life at 90 Days Post Enrollment | Symptom Stability | 0 Scores on a scale (difference) |
| Control | Change in Quality of Life at 90 Days Post Enrollment | Quality of Life | 8.3 Scores on a scale (difference) |
| BodyPort | Change in Quality of Life at 90 Days Post Enrollment | Self-Efficacy | 0 Scores on a scale (difference) |
| BodyPort | Change in Quality of Life at 90 Days Post Enrollment | Physical Limitation | -4.2 Scores on a scale (difference) |
| BodyPort | Change in Quality of Life at 90 Days Post Enrollment | Symptom Stability | 0 Scores on a scale (difference) |
| BodyPort | Change in Quality of Life at 90 Days Post Enrollment | Symptom Frequency | 0 Scores on a scale (difference) |
| BodyPort | Change in Quality of Life at 90 Days Post Enrollment | Symptom Burden | 0 Scores on a scale (difference) |
| BodyPort | Change in Quality of Life at 90 Days Post Enrollment | Total Symptom Score | 0 Scores on a scale (difference) |
| BodyPort | Change in Quality of Life at 90 Days Post Enrollment | Quality of Life | 8.3 Scores on a scale (difference) |
| BodyPort | Change in Quality of Life at 90 Days Post Enrollment | Social Limitation | 0 Scores on a scale (difference) |
| BodyPort | Change in Quality of Life at 90 Days Post Enrollment | Clinical Summary Score | 0 Scores on a scale (difference) |
| BodyPort | Change in Quality of Life at 90 Days Post Enrollment | Overall Summary Score | 2.1 Scores on a scale (difference) |
| Noom | Change in Quality of Life at 90 Days Post Enrollment | Physical Limitation | 0 Scores on a scale (difference) |
| Noom | Change in Quality of Life at 90 Days Post Enrollment | Symptom Stability | 0 Scores on a scale (difference) |
| Noom | Change in Quality of Life at 90 Days Post Enrollment | Quality of Life | 4.2 Scores on a scale (difference) |
| Noom | Change in Quality of Life at 90 Days Post Enrollment | Clinical Summary Score | 2.8 Scores on a scale (difference) |
| Noom | Change in Quality of Life at 90 Days Post Enrollment | Self-Efficacy | 0 Scores on a scale (difference) |
| Noom | Change in Quality of Life at 90 Days Post Enrollment | Symptom Frequency | 0 Scores on a scale (difference) |
| Noom | Change in Quality of Life at 90 Days Post Enrollment | Overall Summary Score | 3.4 Scores on a scale (difference) |
| Noom | Change in Quality of Life at 90 Days Post Enrollment | Total Symptom Score | 4.2 Scores on a scale (difference) |
| Noom | Change in Quality of Life at 90 Days Post Enrollment | Social Limitation | 0 Scores on a scale (difference) |
| Noom | Change in Quality of Life at 90 Days Post Enrollment | Symptom Burden | 8.3 Scores on a scale (difference) |
| Conversa | Change in Quality of Life at 90 Days Post Enrollment | Social Limitation | 0 Scores on a scale (difference) |
| Conversa | Change in Quality of Life at 90 Days Post Enrollment | Self-Efficacy | 0 Scores on a scale (difference) |
| Conversa | Change in Quality of Life at 90 Days Post Enrollment | Quality of Life | 0 Scores on a scale (difference) |
| Conversa | Change in Quality of Life at 90 Days Post Enrollment | Symptom Stability | 0 Scores on a scale (difference) |
| Conversa | Change in Quality of Life at 90 Days Post Enrollment | Symptom Frequency | 3.1 Scores on a scale (difference) |
| Conversa | Change in Quality of Life at 90 Days Post Enrollment | Overall Summary Score | 2.1 Scores on a scale (difference) |
| Conversa | Change in Quality of Life at 90 Days Post Enrollment | Clinical Summary Score | -1.6 Scores on a scale (difference) |
| Conversa | Change in Quality of Life at 90 Days Post Enrollment | Symptom Burden | 0 Scores on a scale (difference) |
| Conversa | Change in Quality of Life at 90 Days Post Enrollment | Physical Limitation | -4.2 Scores on a scale (difference) |
| Conversa | Change in Quality of Life at 90 Days Post Enrollment | Total Symptom Score | 1 Scores on a scale (difference) |
Secondary
Average Number of Daily Interactions With the Device
Information collected from device metric to assess frequency of use
Time frame: 180 days post enrollment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Average Number of Daily Interactions With the Device | .6 Daily interactions with device | Standard Deviation 0.4 |
| BodyPort | Average Number of Daily Interactions With the Device | .9 Daily interactions with device | Standard Deviation 0.8 |
| Noom | Average Number of Daily Interactions With the Device | .2 Daily interactions with device | Standard Deviation 0.09 |
Secondary
Average Number of Daily Interactions With the Device
Information collected from device metric to assess frequency of use
Time frame: 90 days post enrollment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Average Number of Daily Interactions With the Device | .7 Interactions per day with device | Standard Deviation 0.4 |
| BodyPort | Average Number of Daily Interactions With the Device | .5 Interactions per day with device | Standard Deviation 0.4 |
| Noom | Average Number of Daily Interactions With the Device | .1 Interactions per day with device | Standard Deviation 0.04 |
Secondary
Average Time Devoted by Provider to Patient Care
Via medical record review of chart openings per patient
Time frame: 90 days post enrollment
Population: Current EHR infrastructure does not capture chart openings, thus outcome cannot be assessed because data not collected.
Secondary
Average Time Devoted by Provider to Patient Care
Via medical record review of chart openings per patient
Time frame: 180 days post enrollment
Population: Current EHR infrastructure does not capture chart openings, thus outcome cannot be assessed because data not collected.
Secondary
Change in Quality of Life at 180 Days Post Enrollment
Assessed by the change in score of the Kansas City Cardiomyopathy Questionnaire (KCCQ) survey between day 90 post enrollment and at day 180 post enrollment. This survey is a 23 item self-administered instrument used to quantify a patient's perception of health status. For each domain reported, an overall summary scored is derived and transformed to a score range of 0-100. The Total Symptom score is the mean of the Symptom Frequency and Symptom Burden scores. The Overall Summary Score is the mean of the Physical Limitation, Total Symptom, Quality of Life and Social Limitation Scores. The Clinical Summary score is the mean of the Physical Limitation and Total Symptom scores. All KCCQ scores are summarized in 25-point ranges, where scores represent health status as follows: 0 to 24: very poor to poor; 25 to 49: poor to fair; 50 to 74: fair to good; and 75 to 100: good to excellent.
Time frame: 180 days post enrollment
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Control | Change in Quality of Life at 180 Days Post Enrollment | Physical Limitation | -4.2 Scores on a scale (difference) |
| Control | Change in Quality of Life at 180 Days Post Enrollment | Symptom Stability | 0 Scores on a scale (difference) |
| Control | Change in Quality of Life at 180 Days Post Enrollment | Symptom Frequency | 0 Scores on a scale (difference) |
| Control | Change in Quality of Life at 180 Days Post Enrollment | Symptom Burden | 0 Scores on a scale (difference) |
| Control | Change in Quality of Life at 180 Days Post Enrollment | Total Symptom Score | 0 Scores on a scale (difference) |
| Control | Change in Quality of Life at 180 Days Post Enrollment | Self- Efficacy | 0 Scores on a scale (difference) |
| Control | Change in Quality of Life at 180 Days Post Enrollment | Quality of Life | 8.3 Scores on a scale (difference) |
| Control | Change in Quality of Life at 180 Days Post Enrollment | Social Limitation | 0 Scores on a scale (difference) |
| Control | Change in Quality of Life at 180 Days Post Enrollment | Clinical Summary Score | -1 Scores on a scale (difference) |
| Control | Change in Quality of Life at 180 Days Post Enrollment | Overall Summary Score | 3.6 Scores on a scale (difference) |
| BodyPort | Change in Quality of Life at 180 Days Post Enrollment | Symptom Frequency | 0 Scores on a scale (difference) |
| BodyPort | Change in Quality of Life at 180 Days Post Enrollment | Clinical Summary Score | -3.1 Scores on a scale (difference) |
| BodyPort | Change in Quality of Life at 180 Days Post Enrollment | Symptom Burden | 0 Scores on a scale (difference) |
| BodyPort | Change in Quality of Life at 180 Days Post Enrollment | Total Symptom Score | 0 Scores on a scale (difference) |
| BodyPort | Change in Quality of Life at 180 Days Post Enrollment | Self- Efficacy | 0 Scores on a scale (difference) |
| BodyPort | Change in Quality of Life at 180 Days Post Enrollment | Quality of Life | 0 Scores on a scale (difference) |
| BodyPort | Change in Quality of Life at 180 Days Post Enrollment | Overall Summary Score | 0 Scores on a scale (difference) |
| BodyPort | Change in Quality of Life at 180 Days Post Enrollment | Social Limitation | 0 Scores on a scale (difference) |
| BodyPort | Change in Quality of Life at 180 Days Post Enrollment | Physical Limitation | -8.3 Scores on a scale (difference) |
| BodyPort | Change in Quality of Life at 180 Days Post Enrollment | Symptom Stability | 0 Scores on a scale (difference) |
| Noom | Change in Quality of Life at 180 Days Post Enrollment | Social Limitation | -3.1 Scores on a scale (difference) |
| Noom | Change in Quality of Life at 180 Days Post Enrollment | Quality of Life | 0 Scores on a scale (difference) |
| Noom | Change in Quality of Life at 180 Days Post Enrollment | Overall Summary Score | -1 Scores on a scale (difference) |
| Noom | Change in Quality of Life at 180 Days Post Enrollment | Physical Limitation | -2.1 Scores on a scale (difference) |
| Noom | Change in Quality of Life at 180 Days Post Enrollment | Symptom Burden | 0 Scores on a scale (difference) |
| Noom | Change in Quality of Life at 180 Days Post Enrollment | Self- Efficacy | 0 Scores on a scale (difference) |
| Noom | Change in Quality of Life at 180 Days Post Enrollment | Clinical Summary Score | 1 Scores on a scale (difference) |
| Noom | Change in Quality of Life at 180 Days Post Enrollment | Symptom Stability | 0 Scores on a scale (difference) |
| Noom | Change in Quality of Life at 180 Days Post Enrollment | Total Symptom Score | 7.3 Scores on a scale (difference) |
| Noom | Change in Quality of Life at 180 Days Post Enrollment | Symptom Frequency | 6.3 Scores on a scale (difference) |
| Conversa | Change in Quality of Life at 180 Days Post Enrollment | Total Symptom Score | 0 Scores on a scale (difference) |
| Conversa | Change in Quality of Life at 180 Days Post Enrollment | Social Limitation | 0 Scores on a scale (difference) |
| Conversa | Change in Quality of Life at 180 Days Post Enrollment | Self- Efficacy | 0 Scores on a scale (difference) |
| Conversa | Change in Quality of Life at 180 Days Post Enrollment | Overall Summary Score | 0 Scores on a scale (difference) |
| Conversa | Change in Quality of Life at 180 Days Post Enrollment | Quality of Life | 0 Scores on a scale (difference) |
| Conversa | Change in Quality of Life at 180 Days Post Enrollment | Symptom Stability | 0 Scores on a scale (difference) |
| Conversa | Change in Quality of Life at 180 Days Post Enrollment | Symptom Frequency | 0 Scores on a scale (difference) |
| Conversa | Change in Quality of Life at 180 Days Post Enrollment | Symptom Burden | 0 Scores on a scale (difference) |
| Conversa | Change in Quality of Life at 180 Days Post Enrollment | Physical Limitation | -2.1 Scores on a scale (difference) |
| Conversa | Change in Quality of Life at 180 Days Post Enrollment | Clinical Summary Score | -1 Scores on a scale (difference) |
Secondary
Mortality Rate at 90 Days Post Enrollment
Via medical record review. Number of deaths between enrollment and 90 days post enrollment.
Time frame: 90 days post enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Mortality Rate at 90 Days Post Enrollment | 0 Participants |
| BodyPort | Mortality Rate at 90 Days Post Enrollment | 0 Participants |
| Noom | Mortality Rate at 90 Days Post Enrollment | 0 Participants |
| Conversa | Mortality Rate at 90 Days Post Enrollment | 1 Participants |
Secondary
Mortality Rates at 180 Days Post Enrollment
Via medical record review. Number of deaths between day 90 and day 180 post enrollment.
Time frame: 180 days post enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Mortality Rates at 180 Days Post Enrollment | 1 Participants |
| BodyPort | Mortality Rates at 180 Days Post Enrollment | 2 Participants |
| Noom | Mortality Rates at 180 Days Post Enrollment | 0 Participants |
| Conversa | Mortality Rates at 180 Days Post Enrollment | 1 Participants |
Secondary
Number of In-person and Remote Clinic Visits at 180 Days Post Enrollment
Via medical record review. Number of visits between day 90 and day 180 post enrollment.
Time frame: 180 days post enrollment
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Control | Number of In-person and Remote Clinic Visits at 180 Days Post Enrollment | Number of in-person clinic visits | 1 Clinic visits |
| Control | Number of In-person and Remote Clinic Visits at 180 Days Post Enrollment | Number of virtual/phone clinic visits | 0 Clinic visits |
| BodyPort | Number of In-person and Remote Clinic Visits at 180 Days Post Enrollment | Number of virtual/phone clinic visits | 0 Clinic visits |
| BodyPort | Number of In-person and Remote Clinic Visits at 180 Days Post Enrollment | Number of in-person clinic visits | 0 Clinic visits |
| Noom | Number of In-person and Remote Clinic Visits at 180 Days Post Enrollment | Number of in-person clinic visits | 1 Clinic visits |
| Noom | Number of In-person and Remote Clinic Visits at 180 Days Post Enrollment | Number of virtual/phone clinic visits | 0 Clinic visits |
| Conversa | Number of In-person and Remote Clinic Visits at 180 Days Post Enrollment | Number of in-person clinic visits | 0 Clinic visits |
| Conversa | Number of In-person and Remote Clinic Visits at 180 Days Post Enrollment | Number of virtual/phone clinic visits | 0 Clinic visits |
Secondary
Number of In-person and Remote Clinic Visits at 90 Days Post Enrollment
Via medical record review. Number of visits between enrollment and 90 days post enrollment.
Time frame: 90 days post enrollment
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Control | Number of In-person and Remote Clinic Visits at 90 Days Post Enrollment | Number of in-person clinic visits | 2 Clinic visits |
| Control | Number of In-person and Remote Clinic Visits at 90 Days Post Enrollment | Number of virtual/phone clinic visits | 1 Clinic visits |
| BodyPort | Number of In-person and Remote Clinic Visits at 90 Days Post Enrollment | Number of virtual/phone clinic visits | 1 Clinic visits |
| BodyPort | Number of In-person and Remote Clinic Visits at 90 Days Post Enrollment | Number of in-person clinic visits | 2 Clinic visits |
| Noom | Number of In-person and Remote Clinic Visits at 90 Days Post Enrollment | Number of in-person clinic visits | 2 Clinic visits |
| Noom | Number of In-person and Remote Clinic Visits at 90 Days Post Enrollment | Number of virtual/phone clinic visits | 2 Clinic visits |
| Conversa | Number of In-person and Remote Clinic Visits at 90 Days Post Enrollment | Number of in-person clinic visits | 2 Clinic visits |
| Conversa | Number of In-person and Remote Clinic Visits at 90 Days Post Enrollment | Number of virtual/phone clinic visits | 1 Clinic visits |
Secondary
Number of Participants With Acute Kidney Injury (AKI) Development at 180 Days Post Enrollment
Via medical record review, defined as an increase in serum creatinine by 50% over baseline (pre-enrollment creatinine) at any point between day 90 and day 180 post enrollment.
Time frame: 180 days post enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Number of Participants With Acute Kidney Injury (AKI) Development at 180 Days Post Enrollment | 3 Participants |
| BodyPort | Number of Participants With Acute Kidney Injury (AKI) Development at 180 Days Post Enrollment | 2 Participants |
| Noom | Number of Participants With Acute Kidney Injury (AKI) Development at 180 Days Post Enrollment | 3 Participants |
| Conversa | Number of Participants With Acute Kidney Injury (AKI) Development at 180 Days Post Enrollment | 3 Participants |
Secondary
Number of Participants With Acute Kidney Injury (AKI) Development at 90 Days Post Enrollment
Via medical record review, defined as an increase in serum creatinine by 50% over baseline (pre-enrollment creatinine) at any point between enrollment day 90 post enrollment.
Time frame: 90 days post enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Number of Participants With Acute Kidney Injury (AKI) Development at 90 Days Post Enrollment | 4 Participants |
| BodyPort | Number of Participants With Acute Kidney Injury (AKI) Development at 90 Days Post Enrollment | 6 Participants |
| Noom | Number of Participants With Acute Kidney Injury (AKI) Development at 90 Days Post Enrollment | 2 Participants |
| Conversa | Number of Participants With Acute Kidney Injury (AKI) Development at 90 Days Post Enrollment | 6 Participants |
Secondary
Number of Participants With at Least One Clinic No-show at 90 Days Post Enrollment
Via medical record review; number of participants with at least one clinic no show between enrollment and day 90 post enrollment.
Time frame: 90 days post enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Number of Participants With at Least One Clinic No-show at 90 Days Post Enrollment | 12 Participants |
| BodyPort | Number of Participants With at Least One Clinic No-show at 90 Days Post Enrollment | 12 Participants |
| Noom | Number of Participants With at Least One Clinic No-show at 90 Days Post Enrollment | 8 Participants |
| Conversa | Number of Participants With at Least One Clinic No-show at 90 Days Post Enrollment | 10 Participants |
Secondary
Number of Participants With Emergency Department (ED) Visits at 90 Days Post Enrollment
Via medical record review. Number of participants with an emergency department visit between enrollment and day 90 post enrollment.
Time frame: 90 days post enrollment
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control | Number of Participants With Emergency Department (ED) Visits at 90 Days Post Enrollment | Participants with ED visit | 10 Participants |
| Control | Number of Participants With Emergency Department (ED) Visits at 90 Days Post Enrollment | Participants with ED visit related to CHF | 4 Participants |
| BodyPort | Number of Participants With Emergency Department (ED) Visits at 90 Days Post Enrollment | Participants with ED visit related to CHF | 3 Participants |
| BodyPort | Number of Participants With Emergency Department (ED) Visits at 90 Days Post Enrollment | Participants with ED visit | 12 Participants |
| Noom | Number of Participants With Emergency Department (ED) Visits at 90 Days Post Enrollment | Participants with ED visit | 10 Participants |
| Noom | Number of Participants With Emergency Department (ED) Visits at 90 Days Post Enrollment | Participants with ED visit related to CHF | 4 Participants |
| Conversa | Number of Participants With Emergency Department (ED) Visits at 90 Days Post Enrollment | Participants with ED visit | 14 Participants |
| Conversa | Number of Participants With Emergency Department (ED) Visits at 90 Days Post Enrollment | Participants with ED visit related to CHF | 4 Participants |
Secondary
Number of Participants With Emergency Department Visits at 180 Days Post Enrollment
Via medical record review. Number of participants with an emergency department visit between day 90 and day 180 post enrollment.
Time frame: 180 days post enrollment
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control | Number of Participants With Emergency Department Visits at 180 Days Post Enrollment | Participants with ED visit | 8 Participants |
| Control | Number of Participants With Emergency Department Visits at 180 Days Post Enrollment | Participants with ED visit related to CHF | 4 Participants |
| BodyPort | Number of Participants With Emergency Department Visits at 180 Days Post Enrollment | Participants with ED visit related to CHF | 3 Participants |
| BodyPort | Number of Participants With Emergency Department Visits at 180 Days Post Enrollment | Participants with ED visit | 12 Participants |
| Noom | Number of Participants With Emergency Department Visits at 180 Days Post Enrollment | Participants with ED visit | 13 Participants |
| Noom | Number of Participants With Emergency Department Visits at 180 Days Post Enrollment | Participants with ED visit related to CHF | 4 Participants |
| Conversa | Number of Participants With Emergency Department Visits at 180 Days Post Enrollment | Participants with ED visit | 13 Participants |
| Conversa | Number of Participants With Emergency Department Visits at 180 Days Post Enrollment | Participants with ED visit related to CHF | 1 Participants |
Secondary
Number of Participants With Hospital Admission at 180 Days Post Enrollment
Via medical record review. This measure is calculated as the number of participants with a hospital admission from day 90 to day 180 post enrollment.
Time frame: 180 days post enrollment
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control | Number of Participants With Hospital Admission at 180 Days Post Enrollment | Participants with hospital admission | 10 Participants |
| Control | Number of Participants With Hospital Admission at 180 Days Post Enrollment | Participants with hospital admission related to CHF | 3 Participants |
| BodyPort | Number of Participants With Hospital Admission at 180 Days Post Enrollment | Participants with hospital admission related to CHF | 5 Participants |
| BodyPort | Number of Participants With Hospital Admission at 180 Days Post Enrollment | Participants with hospital admission | 15 Participants |
| Noom | Number of Participants With Hospital Admission at 180 Days Post Enrollment | Participants with hospital admission | 15 Participants |
| Noom | Number of Participants With Hospital Admission at 180 Days Post Enrollment | Participants with hospital admission related to CHF | 3 Participants |
| Conversa | Number of Participants With Hospital Admission at 180 Days Post Enrollment | Participants with hospital admission | 14 Participants |
| Conversa | Number of Participants With Hospital Admission at 180 Days Post Enrollment | Participants with hospital admission related to CHF | 4 Participants |
Secondary
Number of Participants With Hospital Admission at 90 Days Post Enrollment
Via medical record review. Number of patients with a hospital admission between enrollment to day 90 post enrollment.
Time frame: 90 days post enrollment
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control | Number of Participants With Hospital Admission at 90 Days Post Enrollment | Participants with hospital admission | 11 Participants |
| Control | Number of Participants With Hospital Admission at 90 Days Post Enrollment | Participants with hospital admission related to congestive heart failure (CHF) | 4 Participants |
| BodyPort | Number of Participants With Hospital Admission at 90 Days Post Enrollment | Participants with hospital admission related to congestive heart failure (CHF) | 6 Participants |
| BodyPort | Number of Participants With Hospital Admission at 90 Days Post Enrollment | Participants with hospital admission | 16 Participants |
| Noom | Number of Participants With Hospital Admission at 90 Days Post Enrollment | Participants with hospital admission | 14 Participants |
| Noom | Number of Participants With Hospital Admission at 90 Days Post Enrollment | Participants with hospital admission related to congestive heart failure (CHF) | 2 Participants |
| Conversa | Number of Participants With Hospital Admission at 90 Days Post Enrollment | Participants with hospital admission | 17 Participants |
| Conversa | Number of Participants With Hospital Admission at 90 Days Post Enrollment | Participants with hospital admission related to congestive heart failure (CHF) | 3 Participants |
Secondary
Number of Phone Calls Between Provider and Participant at 180 Days Post Enrollment
Via medical record review of telephone logs
Time frame: 180 days post enrollment
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Control | Number of Phone Calls Between Provider and Participant at 180 Days Post Enrollment | Number of calls to clinic with questions/inquiry for provider | 0 Patient-provider calls |
| Control | Number of Phone Calls Between Provider and Participant at 180 Days Post Enrollment | Number of calls by provider/clinic to patient for check-in | 0 Patient-provider calls |
| Control | Number of Phone Calls Between Provider and Participant at 180 Days Post Enrollment | Number of calls by provider/clinic to patient with test results | 0 Patient-provider calls |
| Control | Number of Phone Calls Between Provider and Participant at 180 Days Post Enrollment | Number of appointment reminder calls made to patient | 0 Patient-provider calls |
| BodyPort | Number of Phone Calls Between Provider and Participant at 180 Days Post Enrollment | Number of calls by provider/clinic to patient for check-in | 0 Patient-provider calls |
| BodyPort | Number of Phone Calls Between Provider and Participant at 180 Days Post Enrollment | Number of calls by provider/clinic to patient with test results | 0 Patient-provider calls |
| BodyPort | Number of Phone Calls Between Provider and Participant at 180 Days Post Enrollment | Number of appointment reminder calls made to patient | 0 Patient-provider calls |
| BodyPort | Number of Phone Calls Between Provider and Participant at 180 Days Post Enrollment | Number of calls to clinic with questions/inquiry for provider | 0 Patient-provider calls |
| Noom | Number of Phone Calls Between Provider and Participant at 180 Days Post Enrollment | Number of calls by provider/clinic to patient with test results | 0 Patient-provider calls |
| Noom | Number of Phone Calls Between Provider and Participant at 180 Days Post Enrollment | Number of calls by provider/clinic to patient for check-in | 0 Patient-provider calls |
| Noom | Number of Phone Calls Between Provider and Participant at 180 Days Post Enrollment | Number of appointment reminder calls made to patient | 0 Patient-provider calls |
| Noom | Number of Phone Calls Between Provider and Participant at 180 Days Post Enrollment | Number of calls to clinic with questions/inquiry for provider | 0 Patient-provider calls |
| Conversa | Number of Phone Calls Between Provider and Participant at 180 Days Post Enrollment | Number of appointment reminder calls made to patient | 0 Patient-provider calls |
| Conversa | Number of Phone Calls Between Provider and Participant at 180 Days Post Enrollment | Number of calls by provider/clinic to patient for check-in | 0 Patient-provider calls |
| Conversa | Number of Phone Calls Between Provider and Participant at 180 Days Post Enrollment | Number of calls to clinic with questions/inquiry for provider | 0 Patient-provider calls |
| Conversa | Number of Phone Calls Between Provider and Participant at 180 Days Post Enrollment | Number of calls by provider/clinic to patient with test results | 0 Patient-provider calls |
Secondary
Number of Phone Calls Between Provider and Participant at 90 Days Post Enrollment
Via medical record review of telephone logs between enrollment and day 90 post enrollment.
Time frame: 90 days post enrollment
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Control | Number of Phone Calls Between Provider and Participant at 90 Days Post Enrollment | Number of calls to clinic with questions/inquiry for provider | 1 Provider-Participant calls |
| Control | Number of Phone Calls Between Provider and Participant at 90 Days Post Enrollment | Number of calls by provider/clinic to patient for check-in | 2 Provider-Participant calls |
| Control | Number of Phone Calls Between Provider and Participant at 90 Days Post Enrollment | Number of calls by provider/clinic to patient with test results | 2 Provider-Participant calls |
| Control | Number of Phone Calls Between Provider and Participant at 90 Days Post Enrollment | Number of appointment reminder calls made to patient | 3 Provider-Participant calls |
| BodyPort | Number of Phone Calls Between Provider and Participant at 90 Days Post Enrollment | Number of calls by provider/clinic to patient for check-in | 2 Provider-Participant calls |
| BodyPort | Number of Phone Calls Between Provider and Participant at 90 Days Post Enrollment | Number of calls by provider/clinic to patient with test results | 2 Provider-Participant calls |
| BodyPort | Number of Phone Calls Between Provider and Participant at 90 Days Post Enrollment | Number of appointment reminder calls made to patient | 2 Provider-Participant calls |
| BodyPort | Number of Phone Calls Between Provider and Participant at 90 Days Post Enrollment | Number of calls to clinic with questions/inquiry for provider | 1 Provider-Participant calls |
| Noom | Number of Phone Calls Between Provider and Participant at 90 Days Post Enrollment | Number of calls by provider/clinic to patient with test results | 1 Provider-Participant calls |
| Noom | Number of Phone Calls Between Provider and Participant at 90 Days Post Enrollment | Number of calls by provider/clinic to patient for check-in | 2 Provider-Participant calls |
| Noom | Number of Phone Calls Between Provider and Participant at 90 Days Post Enrollment | Number of appointment reminder calls made to patient | 2 Provider-Participant calls |
| Noom | Number of Phone Calls Between Provider and Participant at 90 Days Post Enrollment | Number of calls to clinic with questions/inquiry for provider | 1 Provider-Participant calls |
| Conversa | Number of Phone Calls Between Provider and Participant at 90 Days Post Enrollment | Number of appointment reminder calls made to patient | 2 Provider-Participant calls |
| Conversa | Number of Phone Calls Between Provider and Participant at 90 Days Post Enrollment | Number of calls by provider/clinic to patient for check-in | 2 Provider-Participant calls |
| Conversa | Number of Phone Calls Between Provider and Participant at 90 Days Post Enrollment | Number of calls to clinic with questions/inquiry for provider | 2 Provider-Participant calls |
| Conversa | Number of Phone Calls Between Provider and Participant at 90 Days Post Enrollment | Number of calls by provider/clinic to patient with test results | 1 Provider-Participant calls |
Secondary
Number of Remote Device Checks by Providers at 180 Days Post Enrollment
Via medical record review
Time frame: 180 days post enrollment
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control | Number of Remote Device Checks by Providers at 180 Days Post Enrollment | 0 Remote device checks |
| BodyPort | Number of Remote Device Checks by Providers at 180 Days Post Enrollment | 0 Remote device checks |
| Noom | Number of Remote Device Checks by Providers at 180 Days Post Enrollment | 0 Remote device checks |
| Conversa | Number of Remote Device Checks by Providers at 180 Days Post Enrollment | 0 Remote device checks |
Secondary
Number of Remote Device Checks by Providers at 90 Days Post Enrollment
Via medical record review
Time frame: 90 days post enrollment
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control | Number of Remote Device Checks by Providers at 90 Days Post Enrollment | 17 Remote device checks |
| BodyPort | Number of Remote Device Checks by Providers at 90 Days Post Enrollment | 1 Remote device checks |
| Noom | Number of Remote Device Checks by Providers at 90 Days Post Enrollment | 3 Remote device checks |
| Conversa | Number of Remote Device Checks by Providers at 90 Days Post Enrollment | 6 Remote device checks |
Secondary
Number of Subjects Using Guideline-directed Medical Therapy at 180 Days Post Enrollment
Number of patients having documented prescription of all of the following medication classes between day 90 post enrollment and day 180 post enrollment: beta blockers, angiotensin-converting enzyme inhibitors (ACEi)/angiotensin receptor blockers (ARBs)/angiotensin receptor-neprilysin inhibitors (ARNI), sodium/glucose cotransporter-2 inhibitors (SGLT2i) and aldosterone receptor antagonists (MRAs); assessed via Surescripts data collection.
Time frame: 180 days post enrollment
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control | Number of Subjects Using Guideline-directed Medical Therapy at 180 Days Post Enrollment | Beta Blocker | 40 Participants |
| Control | Number of Subjects Using Guideline-directed Medical Therapy at 180 Days Post Enrollment | ACEi/ARB/ARNI | 34 Participants |
| Control | Number of Subjects Using Guideline-directed Medical Therapy at 180 Days Post Enrollment | MRA | 23 Participants |
| Control | Number of Subjects Using Guideline-directed Medical Therapy at 180 Days Post Enrollment | SGLT2i | 17 Participants |
| BodyPort | Number of Subjects Using Guideline-directed Medical Therapy at 180 Days Post Enrollment | ACEi/ARB/ARNI | 35 Participants |
| BodyPort | Number of Subjects Using Guideline-directed Medical Therapy at 180 Days Post Enrollment | MRA | 24 Participants |
| BodyPort | Number of Subjects Using Guideline-directed Medical Therapy at 180 Days Post Enrollment | SGLT2i | 13 Participants |
| BodyPort | Number of Subjects Using Guideline-directed Medical Therapy at 180 Days Post Enrollment | Beta Blocker | 38 Participants |
| Noom | Number of Subjects Using Guideline-directed Medical Therapy at 180 Days Post Enrollment | MRA | 24 Participants |
| Noom | Number of Subjects Using Guideline-directed Medical Therapy at 180 Days Post Enrollment | ACEi/ARB/ARNI | 32 Participants |
| Noom | Number of Subjects Using Guideline-directed Medical Therapy at 180 Days Post Enrollment | SGLT2i | 17 Participants |
| Noom | Number of Subjects Using Guideline-directed Medical Therapy at 180 Days Post Enrollment | Beta Blocker | 40 Participants |
| Conversa | Number of Subjects Using Guideline-directed Medical Therapy at 180 Days Post Enrollment | SGLT2i | 17 Participants |
| Conversa | Number of Subjects Using Guideline-directed Medical Therapy at 180 Days Post Enrollment | ACEi/ARB/ARNI | 32 Participants |
| Conversa | Number of Subjects Using Guideline-directed Medical Therapy at 180 Days Post Enrollment | Beta Blocker | 40 Participants |
| Conversa | Number of Subjects Using Guideline-directed Medical Therapy at 180 Days Post Enrollment | MRA | 25 Participants |
Secondary
Number of Subjects Using Guideline-directed Medical Therapy at 90 Days Post Enrollment
Number of patients having documented prescription of all of the following medication classes between enrollment and day 90 post enrollment: beta blockers, angiotensin-converting enzyme inhibitors (ACEi)/angiotensin receptor blockers (ARBs)/angiotensin receptor-neprilysin inhibitors (ARNI), sodium/glucose cotransporter-2 inhibitors (SGLT2i) and aldosterone receptor antagonists (MRAs); assessed via Surescripts data collection.
Time frame: 90 days post enrollment
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control | Number of Subjects Using Guideline-directed Medical Therapy at 90 Days Post Enrollment | Beta-blocker | 42 Participants |
| Control | Number of Subjects Using Guideline-directed Medical Therapy at 90 Days Post Enrollment | ACEi/ARB/ARNI | 32 Participants |
| Control | Number of Subjects Using Guideline-directed Medical Therapy at 90 Days Post Enrollment | SGLT2i | 15 Participants |
| Control | Number of Subjects Using Guideline-directed Medical Therapy at 90 Days Post Enrollment | MRA | 25 Participants |
| BodyPort | Number of Subjects Using Guideline-directed Medical Therapy at 90 Days Post Enrollment | Beta-blocker | 39 Participants |
| BodyPort | Number of Subjects Using Guideline-directed Medical Therapy at 90 Days Post Enrollment | SGLT2i | 13 Participants |
| BodyPort | Number of Subjects Using Guideline-directed Medical Therapy at 90 Days Post Enrollment | ACEi/ARB/ARNI | 36 Participants |
| BodyPort | Number of Subjects Using Guideline-directed Medical Therapy at 90 Days Post Enrollment | MRA | 25 Participants |
| Noom | Number of Subjects Using Guideline-directed Medical Therapy at 90 Days Post Enrollment | Beta-blocker | 41 Participants |
| Noom | Number of Subjects Using Guideline-directed Medical Therapy at 90 Days Post Enrollment | SGLT2i | 18 Participants |
| Noom | Number of Subjects Using Guideline-directed Medical Therapy at 90 Days Post Enrollment | MRA | 26 Participants |
| Noom | Number of Subjects Using Guideline-directed Medical Therapy at 90 Days Post Enrollment | ACEi/ARB/ARNI | 33 Participants |
| Conversa | Number of Subjects Using Guideline-directed Medical Therapy at 90 Days Post Enrollment | SGLT2i | 17 Participants |
| Conversa | Number of Subjects Using Guideline-directed Medical Therapy at 90 Days Post Enrollment | Beta-blocker | 42 Participants |
| Conversa | Number of Subjects Using Guideline-directed Medical Therapy at 90 Days Post Enrollment | MRA | 21 Participants |
| Conversa | Number of Subjects Using Guideline-directed Medical Therapy at 90 Days Post Enrollment | ACEi/ARB/ARNI | 30 Participants |
Secondary
Number of Subjects Who Complete Digital Health Product Set up
Assessed as number of subjects who used device at least once during their duration in the study, up to 90 days post enrollment.
Time frame: 90 days post enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Number of Subjects Who Complete Digital Health Product Set up | 43 Participants |
| BodyPort | Number of Subjects Who Complete Digital Health Product Set up | 23 Participants |
| Noom | Number of Subjects Who Complete Digital Health Product Set up | 33 Participants |
Secondary
Number of Subjects Who Complete on Boarding and Baseline Assessments
Collected from patient enrollment platform
Time frame: Within one week of consent
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Number of Subjects Who Complete on Boarding and Baseline Assessments | 44 Participants |
| BodyPort | Number of Subjects Who Complete on Boarding and Baseline Assessments | 46 Participants |
| Noom | Number of Subjects Who Complete on Boarding and Baseline Assessments | 46 Participants |
| Conversa | Number of Subjects Who Complete on Boarding and Baseline Assessments | 46 Participants |
Secondary
Number of Weekly Interactions With the Device
Information collected from device metrics to assess frequency of use
Time frame: 90 days post enrollment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Number of Weekly Interactions With the Device | Week 1 | 4 Weekly interactions with device | Standard Deviation 2.2 |
| Control | Number of Weekly Interactions With the Device | Week 2 | 8.1 Weekly interactions with device | Standard Deviation 5.9 |
| Control | Number of Weekly Interactions With the Device | Week 3 | 7.7 Weekly interactions with device | Standard Deviation 5.4 |
| Control | Number of Weekly Interactions With the Device | Week 4 | 8.3 Weekly interactions with device | Standard Deviation 7.5 |
| Control | Number of Weekly Interactions With the Device | Week 5 | 6.8 Weekly interactions with device | Standard Deviation 3.7 |
| Control | Number of Weekly Interactions With the Device | Week 6 | 6.5 Weekly interactions with device | Standard Deviation 3 |
| Control | Number of Weekly Interactions With the Device | Week 7 | 6.5 Weekly interactions with device | Standard Deviation 2.7 |
| Control | Number of Weekly Interactions With the Device | Week 8 | 6.3 Weekly interactions with device | Standard Deviation 3.1 |
| Control | Number of Weekly Interactions With the Device | Week 9 | 5.7 Weekly interactions with device | Standard Deviation 3.3 |
| Control | Number of Weekly Interactions With the Device | Week 10 | 5.9 Weekly interactions with device | Standard Deviation 3.6 |
| Control | Number of Weekly Interactions With the Device | Week 11 | 6.3 Weekly interactions with device | Standard Deviation 2.8 |
| Control | Number of Weekly Interactions With the Device | Week 12 | 6.3 Weekly interactions with device | Standard Deviation 3.2 |
| BodyPort | Number of Weekly Interactions With the Device | Week 12 | 5.8 Weekly interactions with device | Standard Deviation 2.4 |
| BodyPort | Number of Weekly Interactions With the Device | Week 1 | 6.9 Weekly interactions with device | Standard Deviation 5.5 |
| BodyPort | Number of Weekly Interactions With the Device | Week 7 | 6 Weekly interactions with device | Standard Deviation 1.9 |
| BodyPort | Number of Weekly Interactions With the Device | Week 9 | 5.4 Weekly interactions with device | Standard Deviation 2.5 |
| BodyPort | Number of Weekly Interactions With the Device | Week 2 | 6.1 Weekly interactions with device | Standard Deviation 1.8 |
| BodyPort | Number of Weekly Interactions With the Device | Week 6 | 6.6 Weekly interactions with device | Standard Deviation 1.4 |
| BodyPort | Number of Weekly Interactions With the Device | Week 11 | 6.4 Weekly interactions with device | Standard Deviation 1.9 |
| BodyPort | Number of Weekly Interactions With the Device | Week 3 | 5.7 Weekly interactions with device | Standard Deviation 2.2 |
| BodyPort | Number of Weekly Interactions With the Device | Week 8 | 6.8 Weekly interactions with device | Standard Deviation 0.6 |
| BodyPort | Number of Weekly Interactions With the Device | Week 5 | 5.7 Weekly interactions with device | Standard Deviation 2.2 |
| BodyPort | Number of Weekly Interactions With the Device | Week 4 | 5.9 Weekly interactions with device | Standard Deviation 2.1 |
| BodyPort | Number of Weekly Interactions With the Device | Week 10 | 5.5 Weekly interactions with device | Standard Deviation 2.5 |
| Noom | Number of Weekly Interactions With the Device | Week 4 | 1 Weekly interactions with device | Standard Deviation 0.2 |
| Noom | Number of Weekly Interactions With the Device | Week 5 | 1 Weekly interactions with device | Standard Deviation 0.2 |
| Noom | Number of Weekly Interactions With the Device | Week 10 | 1 Weekly interactions with device | Standard Deviation 0.2 |
| Noom | Number of Weekly Interactions With the Device | Week 6 | 1 Weekly interactions with device | Standard Deviation 0.2 |
| Noom | Number of Weekly Interactions With the Device | Week 7 | 1 Weekly interactions with device | Standard Deviation 0.2 |
| Noom | Number of Weekly Interactions With the Device | Week 8 | 1.1 Weekly interactions with device | Standard Deviation 0.3 |
| Noom | Number of Weekly Interactions With the Device | Week 11 | 1.1 Weekly interactions with device | Standard Deviation 0.3 |
| Noom | Number of Weekly Interactions With the Device | Week 1 | 1.8 Weekly interactions with device | Standard Deviation 0.5 |
| Noom | Number of Weekly Interactions With the Device | Week 2 | 1 Weekly interactions with device | Standard Deviation 0.2 |
| Noom | Number of Weekly Interactions With the Device | Week 9 | 1 Weekly interactions with device | Standard Deviation 0.2 |
| Noom | Number of Weekly Interactions With the Device | Week 3 | 1 Weekly interactions with device | Standard Deviation 0 |
| Noom | Number of Weekly Interactions With the Device | Week 12 | 1 Weekly interactions with device | Standard Deviation 0 |
Secondary
Number of Weekly Interactions With the Device
Information collected from device metrics to assess frequency of use
Time frame: 180 days post enrollment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Number of Weekly Interactions With the Device | Week 14 | 6.9 Weekly interactions with device | Standard Deviation 3.6 |
| Control | Number of Weekly Interactions With the Device | Week 17 | 6.1 Weekly interactions with device | Standard Deviation 2.9 |
| Control | Number of Weekly Interactions With the Device | Week 16 | 5.5 Weekly interactions with device | Standard Deviation 2.7 |
| Control | Number of Weekly Interactions With the Device | Week 23 | 5.2 Weekly interactions with device | Standard Deviation 3.3 |
| Control | Number of Weekly Interactions With the Device | Week 18 | 5.6 Weekly interactions with device | Standard Deviation 2.8 |
| Control | Number of Weekly Interactions With the Device | Week 24 | 5.2 Weekly interactions with device | Standard Deviation 3.3 |
| Control | Number of Weekly Interactions With the Device | Week 13 | 6 Weekly interactions with device | Standard Deviation 3.2 |
| Control | Number of Weekly Interactions With the Device | Week 19 | 5.9 Weekly interactions with device | Standard Deviation 3.3 |
| Control | Number of Weekly Interactions With the Device | Week 22 | 5.5 Weekly interactions with device | Standard Deviation 2.6 |
| Control | Number of Weekly Interactions With the Device | Week 15 | 6.3 Weekly interactions with device | Standard Deviation 2.3 |
| Control | Number of Weekly Interactions With the Device | Week 20 | 6.3 Weekly interactions with device | Standard Deviation 2.8 |
| Control | Number of Weekly Interactions With the Device | Week 21 | 5.2 Weekly interactions with device | Standard Deviation 2.5 |
| BodyPort | Number of Weekly Interactions With the Device | Week 20 | 6.8 Weekly interactions with device | Standard Deviation 0.7 |
| BodyPort | Number of Weekly Interactions With the Device | Week 21 | 6.4 Weekly interactions with device | Standard Deviation 1.3 |
| BodyPort | Number of Weekly Interactions With the Device | Week 22 | 6.4 Weekly interactions with device | Standard Deviation 1.8 |
| BodyPort | Number of Weekly Interactions With the Device | Week 24 | 6.3 Weekly interactions with device | Standard Deviation 1.6 |
| BodyPort | Number of Weekly Interactions With the Device | Week 16 | 6.7 Weekly interactions with device | Standard Deviation 0.9 |
| BodyPort | Number of Weekly Interactions With the Device | Week 23 | 6.3 Weekly interactions with device | Standard Deviation 1.6 |
| BodyPort | Number of Weekly Interactions With the Device | Week 17 | 5.8 Weekly interactions with device | Standard Deviation 2.1 |
| BodyPort | Number of Weekly Interactions With the Device | Week 14 | 5.8 Weekly interactions with device | Standard Deviation 2.2 |
| BodyPort | Number of Weekly Interactions With the Device | Week 18 | 6.8 Weekly interactions with device | Standard Deviation 0.4 |
| BodyPort | Number of Weekly Interactions With the Device | Week 13 | 6.5 Weekly interactions with device | Standard Deviation 1.5 |
| BodyPort | Number of Weekly Interactions With the Device | Week 19 | 6.5 Weekly interactions with device | Standard Deviation 1.8 |
| BodyPort | Number of Weekly Interactions With the Device | Week 15 | 6.6 Weekly interactions with device | Standard Deviation 1.3 |
| Noom | Number of Weekly Interactions With the Device | Week 18 | 1.1 Weekly interactions with device | Standard Deviation 0.3 |
| Noom | Number of Weekly Interactions With the Device | Week 13 | 1 Weekly interactions with device | Standard Deviation 0.2 |
| Noom | Number of Weekly Interactions With the Device | Week 14 | 1 Weekly interactions with device | Standard Deviation 0.2 |
| Noom | Number of Weekly Interactions With the Device | Week 15 | 1 Weekly interactions with device | Standard Deviation 0 |
| Noom | Number of Weekly Interactions With the Device | Week 16 | 1.2 Weekly interactions with device | Standard Deviation 0.5 |
| Noom | Number of Weekly Interactions With the Device | Week 17 | 1.1 Weekly interactions with device | Standard Deviation 0.3 |
| Noom | Number of Weekly Interactions With the Device | Week 23 | 1 Weekly interactions with device | Standard Deviation 0.2 |
| Noom | Number of Weekly Interactions With the Device | Week 19 | 1 Weekly interactions with device | Standard Deviation 0.2 |
| Noom | Number of Weekly Interactions With the Device | Week 20 | 1 Weekly interactions with device | Standard Deviation 0.2 |
| Noom | Number of Weekly Interactions With the Device | Week 21 | 1.1 Weekly interactions with device | Standard Deviation 0.3 |
| Noom | Number of Weekly Interactions With the Device | Week 22 | 1.2 Weekly interactions with device | Standard Deviation 0.4 |
| Noom | Number of Weekly Interactions With the Device | Week 24 | 1 Weekly interactions with device | Standard Deviation 0.2 |
Secondary
Prescribing of Guideline-directed Medical Therapy
Documented prescription or change in dosing of any one of the following medication classes: beta blockers, ACEi/ARBs, and/or spironolactone; assessed via Surescripts data collection.
Time frame: 90 days post enrollment
Population: Surescripts data was not made available to investigators, thus we are unable to collect prescription-related data to assess this outcome.
Secondary
Prescribing of Guideline-directed Medical Therapy
Documented prescription or change in dosing of any one of the following medication classes: beta blockers, ACEi/ARBs, and/or spironolactone; assessed via Surescripts data collection.
Time frame: 180 days post enrollment
Population: Surescripts data was not made available to investigators, thus we are unable to collect prescription-related data to assess this outcome.