Evaluating Efficacy of Digital Health Technology in the Treatment of Congestive Heart Failure

Assessing the Efficacy of Digital Health Technology in the Management of Congestive Heart Failure: An Evaluation of Three Novel Digital Health Products

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.

Study Overview

• Status: Completed
• Conditions: Congestive Heart Failure
• Intervention / Treatment: Device: BodyPort; Other: Noom; Other: Conversa

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.

• Study Type: Interventional
• Enrollment (Actual): 182
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale New Haven Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 77 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Patients will receive usual care and no digital health device.
Experimental: BodyPort; Patients will receive the BodyPort device.	Device: BodyPort; Patients will receive BodyPort, a smart scale that provides advanced cardiac monitoring.
Experimental: Noom; Patients will receive a subscription to the Noom platform.	Other: Noom; Patients will receive a subscription to use Noom, a personalized diet and weight management application.
Experimental: Conversa; Patients will receive a subscription to the Conversa platform.	Other: Conversa; patients will receive a subscription to use Conversa, a personalized automated coaching and motivational application.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: Boehringer Ingelheim; Medullan
• Investigators: Principal Investigator: Francis P Wilson, MD MSCE, Yale University

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2020
• Primary Completion (Actual): September 20, 2021
• Study Completion (Actual): December 1, 2021

Study Registration Dates

• First Submitted: May 14, 2020
• First Submitted That Met QC Criteria: May 14, 2020
• First Posted (Actual): May 19, 2020

Study Record Updates

• Last Update Posted (Actual): May 18, 2023
• Last Update Submitted That Met QC Criteria: April 25, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Digital Health
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 2000027325

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified data underlying results will be made available upon publication in an appropriate database.
• IPD Sharing Time Frame: Upon publication; indefinitely
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes