Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Boehringer Ingelheim | INDUSTRY |
| ZS | INDUSTRY |
Not provided
Not provided
Not provided
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.
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:
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Patients will receive usual care and no digital health device. | |
| BodyPort | Experimental | Patients will receive the BodyPort device. |
|
| Noom | Experimental | Patients will receive a subscription to the Noom platform. |
|
| Conversa | Experimental | Patients will receive a subscription to the Conversa platform. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BodyPort | Device | Patients will receive BodyPort, a smart scale that provides advanced cardiac monitoring. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 90 after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Francis P Wilson, MD MSCE | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale New Haven Hospital | New Haven | Connecticut | 06520 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37943227 | Derived | Victoria-Castro AM, Martin ML, Yamamoto Y, Melchinger H, Weinstein J, Nguyen A, Lee KA, Gerber B, Calderon F, Subair L, Lee V, Williams A, Shaw M, Arora T, Garcez A, Desai NR, Ahmad T, Wilson FP. Impact of Digital Health Technology on Quality of Life in Patients With Heart Failure. JACC Heart Fail. 2024 Feb;12(2):336-348. doi: 10.1016/j.jchf.2023.09.022. Epub 2023 Nov 8. |
Not provided
Not provided
Deidentified data underlying results will be made available upon publication in an appropriate database.
Upon publication; indefinitely
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Control | Patients will receive usual care and no digital health device. |
| FG001 | BodyPort | Patients will receive the BodyPort device. BodyPort: Patients will receive BodyPort, a smart scale that provides advanced cardiac monitoring. |
| FG002 | 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. |
| FG003 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Control | Patients will receive usual care and no digital health device. |
| BG001 | BodyPort | Patients will receive the BodyPort device. BodyPort: Patients will receive BodyPort, a smart scale that provides advanced cardiac monitoring. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Median | Inter-Quartile Range | Scores on a scale (difference) | Day 90 after enrollment |
|
Duration of a subject's participation, up to 180 days post enrollment.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | Patients will receive usual care and no digital health device. | 1 |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Francis Perry Wilson | Yale University | 203-737-1704 | francis.p.wilson@yale.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 16, 2021 | Sep 9, 2022 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Noom | Other | Patients will receive a subscription to use Noom, a personalized diet and weight management application. |
|
| Conversa | Other | patients will receive a subscription to use Conversa, a personalized automated coaching and motivational application. |
|
| 180 days post enrollment |
| 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. | 90 days post enrollment |
| 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. | 180 days post enrollment |
| 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. | 90 days post enrollment |
| 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. | 180 days post enrollment |
| 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. | 90 days post enrollment |
| 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. | 180 days post enrollment |
| 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. | 90 days post enrollment |
| 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. | 180 days post enrollment |
| 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. | 90 days post enrollment |
| 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. | 180 days post enrollment |
| Mortality Rate at 90 Days Post Enrollment | Via medical record review. Number of deaths between enrollment and 90 days post enrollment. | 90 days post enrollment |
| Mortality Rates at 180 Days Post Enrollment | Via medical record review. Number of deaths between day 90 and day 180 post enrollment. | 180 days post enrollment |
| 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. | 90 days post enrollment |
| 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. | 90 days post enrollment |
| 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. | 180 days post enrollment |
| Number of Remote Device Checks by Providers at 90 Days Post Enrollment | Via medical record review | 90 days post enrollment |
| Number of Remote Device Checks by Providers at 180 Days Post Enrollment | Via medical record review | 180 days post enrollment |
| 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. | 90 days post enrollment |
| Number of Phone Calls Between Provider and Participant at 180 Days Post Enrollment | Via medical record review of telephone logs | 180 days post enrollment |
| Average Time Devoted by Provider to Patient Care | Via medical record review of chart openings per patient | 90 days post enrollment |
| Average Time Devoted by Provider to Patient Care | Via medical record review of chart openings per patient | 180 days post enrollment |
| Number of Subjects Who Complete on Boarding and Baseline Assessments | Collected from patient enrollment platform | Within one week of consent |
| 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. | 90 days post enrollment |
| Number of Weekly Interactions With the Device | Information collected from device metrics to assess frequency of use | 90 days post enrollment |
| Number of Weekly Interactions With the Device | Information collected from device metrics to assess frequency of use | 180 days post enrollment |
| Average Number of Daily Interactions With the Device | Information collected from device metric to assess frequency of use | 90 days post enrollment |
| Average Number of Daily Interactions With the Device | Information collected from device metric to assess frequency of use | 180 days post enrollment |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Insurance Coverage | Count of Participants | Participants |
|
| Heart Failure Classification | Ejection Fraction of > or = 50% was defined as heart failure with preserved ejection fraction (HFpEF). Ejection Fraction of <50% was defined as heart failure with reduced ejection fraction (HFrEF). Where possible, this diagnosis was confirmed via physician's assessment during a patient's clinic visit within 30 days of enrollment (via medical record review by the study team). | Count of Participants | Participants |
|
| Ejection Fraction, median | Median | Inter-Quartile Range | Percent of ventricular ejection |
|
| New York Heart Association (NYHA) classification | NYHA classification is based on physician classification as described in the subject's medical record. This places patients in one of four categories based on physical limitation: I - No limitation of physical activity II- Slight limitation of physical activity; ordinary activity results in fatigue, palpitations, dyspnea. III-Marked limitation of physical activity; less than ordinary activity causes fatigue, palpitations, dyspnea. IV- Unable to carry on any physical activity without discomfort; symptoms of heart failure at rest. | Count of Participants | Participants |
|
| Cardiac Device | Count of Participants | Participants |
|
| Comorbidities | Count of Participants | Participants |
|
| Medications | Count of Participants | Participants |
|
| Creatinine | Median | Inter-Quartile Range | mg/dL |
|
| Estimated Glomerular Filtration Rate (eGFR) | Median | Inter-Quartile Range | mL/min/1.73m2 |
|
| Potassium | Median | Inter-Quartile Range | mmol/L |
|
| Hemoglobin | Median | Inter-Quartile Range | g/dL |
|
| White Blood Cell (WBC) Count | Median | Inter-Quartile Range | 10^3 cells/µL |
|
| Brain Natriuretic Peptide (BNP) | Median | Inter-Quartile Range | pg/mL |
|
| Platelet count | Median | Inter-Quartile Range | 10^3 cells/µL |
|
| Aspartate aminotransferase (AST) | Median | Inter-Quartile Range | U/L |
|
| Alanine transaminase (ALT) | Median | Inter-Quartile Range | U/L |
|
| Total Bilirubin | Median | Inter-Quartile Range | Mg/dL |
|
| International Normalized Ratio (INR) | Median | Inter-Quartile Range | Ratio |
|
| Prothrombin time (PT) | Median | Inter-Quartile Range | seconds |
|
| Partial Thromboplastin Time (PTT) | Median | Inter-Quartile Range | seconds |
|
| Control |
Patients will receive usual care and no digital health device. |
| OG001 | BodyPort | Patients will receive the BodyPort device. BodyPort: Patients will receive BodyPort, a smart scale that provides advanced cardiac monitoring. |
| OG002 | 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. |
| OG003 | 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. |
|
|
| 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. | Posted | Median | Inter-Quartile Range | Scores on a scale (difference) | 180 days post enrollment |
|
|
|
| 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. | Posted | Count of Participants | Participants | 90 days post enrollment |
|
|
|
| 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. | Posted | Count of Participants | Participants | 180 days post enrollment |
|
|
|
| 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. | Surescripts data was not made available to investigators, thus we are unable to collect prescription-related data to assess this outcome. | Posted | 90 days post enrollment |
|
|
| 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. | Surescripts data was not made available to investigators, thus we are unable to collect prescription-related data to assess this outcome. | Posted | 180 days post enrollment |
|
|
| 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. | Posted | Count of Participants | Participants | 90 days post enrollment |
|
|
|
| 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. | Posted | Count of Participants | Participants | 180 days post enrollment |
|
|
|
| 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. | Posted | Count of Participants | Participants | 90 days post enrollment |
|
|
|
| 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. | Posted | Count of Participants | Participants | 180 days post enrollment |
|
|
|
| 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. | Posted | Count of Participants | Participants | 90 days post enrollment |
|
|
|
| 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. | Posted | Count of Participants | Participants | 180 days post enrollment |
|
|
|
| Secondary | Mortality Rate at 90 Days Post Enrollment | Via medical record review. Number of deaths between enrollment and 90 days post enrollment. | Posted | Count of Participants | Participants | 90 days post enrollment |
|
|
|
| Secondary | Mortality Rates at 180 Days Post Enrollment | Via medical record review. Number of deaths between day 90 and day 180 post enrollment. | Posted | Count of Participants | Participants | 180 days post enrollment |
|
|
|
| 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. | Posted | Count of Participants | Participants | 90 days post enrollment |
|
|
|
| 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. | Posted | Median | Inter-Quartile Range | Clinic visits | 90 days post enrollment |
|
|
|
| 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. | Posted | Median | Inter-Quartile Range | Clinic visits | 180 days post enrollment |
|
|
|
| Secondary | Number of Remote Device Checks by Providers at 90 Days Post Enrollment | Via medical record review | Posted | Median | Inter-Quartile Range | Remote device checks | 90 days post enrollment |
|
|
|
| Secondary | Number of Remote Device Checks by Providers at 180 Days Post Enrollment | Via medical record review | Posted | Median | Inter-Quartile Range | Remote device checks | 180 days post enrollment |
|
|
|
| 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. | Posted | Median | Inter-Quartile Range | Provider-Participant calls | 90 days post enrollment |
|
|
|
| Secondary | Number of Phone Calls Between Provider and Participant at 180 Days Post Enrollment | Via medical record review of telephone logs | Posted | Median | Inter-Quartile Range | Patient-provider calls | 180 days post enrollment |
|
|
|
| Secondary | Average Time Devoted by Provider to Patient Care | Via medical record review of chart openings per patient | Current EHR infrastructure does not capture chart openings, thus outcome cannot be assessed because data not collected. | Posted | 90 days post enrollment |
|
|
| Secondary | Average Time Devoted by Provider to Patient Care | Via medical record review of chart openings per patient | Current EHR infrastructure does not capture chart openings, thus outcome cannot be assessed because data not collected. | Posted | 180 days post enrollment |
|
|
| Secondary | Number of Subjects Who Complete on Boarding and Baseline Assessments | Collected from patient enrollment platform | Posted | Count of Participants | Participants | Within one week of consent |
|
|
|
| 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. | Posted | Count of Participants | Participants | 90 days post enrollment |
|
|
|
| Secondary | Number of Weekly Interactions With the Device | Information collected from device metrics to assess frequency of use | Posted | Mean | Standard Deviation | Weekly interactions with device | 90 days post enrollment |
|
|
|
| Secondary | Number of Weekly Interactions With the Device | Information collected from device metrics to assess frequency of use | Posted | Mean | Standard Deviation | Weekly interactions with device | 180 days post enrollment |
|
|
|
| Secondary | Average Number of Daily Interactions With the Device | Information collected from device metric to assess frequency of use | Posted | Mean | Standard Deviation | Interactions per day with device | 90 days post enrollment |
|
|
|
| Secondary | Average Number of Daily Interactions With the Device | Information collected from device metric to assess frequency of use | Posted | Mean | Standard Deviation | Daily interactions with device | 180 days post enrollment |
|
|
|
| 44 |
| 0 |
| 44 |
| 0 |
| 44 |
| EG001 | BodyPort | Patients will receive the BodyPort device. BodyPort: Patients will receive BodyPort, a smart scale that provides advanced cardiac monitoring. | 2 | 46 | 0 | 46 | 0 | 46 |
| EG002 | 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. | 0 | 46 | 0 | 46 | 0 | 46 |
| EG003 | 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. | 2 | 46 | 0 | 46 | 0 | 46 |
Not provided
Not provided
Not provided
| Symptom Stability |
|
| Symptom Frequency |
|
| Symptom Burden |
|
| Total Symptom Score |
|
| Self- Efficacy |
|
| Quality of Life |
|
| Social Limitation |
|
| Clinical Summary Score |
|
| Overall Summary Score |
|
| Participants with hospital admission related to congestive heart failure (CHF) |
|
| Participants with hospital admission related to CHF |
|
| ACEi/ARB/ARNI |
|
| MRA |
|
| SGLT2i |
|
| ACEi/ARB/ARNI |
|
| MRA |
|
| SGLT2i |
|
| Participants with ED visit related to CHF |
|
| Participants with ED visit related to CHF |
|
| Number of virtual/phone clinic visits |
|
| Number of virtual/phone clinic visits |
|
| Number of calls by provider/clinic to patient for check-in |
|
| Number of calls by provider/clinic to patient with test results |
|
| Number of appointment reminder calls made to patient |
|
| Number of calls by provider/clinic to patient for check-in |
|
| Number of calls by provider/clinic to patient with test results |
|
| Number of appointment reminder calls made to patient |
|
|
| Week 3 |
|
| Week 4 |
|
| Week 5 |
|
| Week 6 |
|
| Week 7 |
|
| Week 8 |
|
| Week 9 |
|
| Week 10 |
|
| Week 11 |
|
| Week 12 |
|
|
| Week 15 |
|
| Week 16 |
|
| Week 17 |
|
| Week 18 |
|
| Week 19 |
|
| Week 20 |
|
| Week 21 |
|
| Week 22 |
|
| Week 23 |
|
| Week 24 |
|