Clinical trial NCT04394754: Evaluating Efficacy of Digital Health Technology in the Treatment of Congestive Heart Failure
Official title: Assessing the Efficacy of Digital Health Technology in the Management of Congestive Heart Failure: An Evaluation of Three Novel Digital Health Products
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congestive Heart Failure
Keywords: Digital Health
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Boehringer Ingelheim
name: ZS
First posted: 2020-05-19
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Quality of Life at 90 Days Post Enrollment
timeFrame: Day 90 after enrollment
Secondary outcomes:
measure: Change in Quality of Life at 180 Days Post Enrollment
timeFrame: 180 days post enrollment
measure: Number of Participants With Hospital Admission at 90 Days Post Enrollment
timeFrame: 90 days post enrollment
measure: Number of Participants With Hospital Admission at 180 Days Post Enrollment
timeFrame: 180 days post enrollment
measure: Prescribing of Guideline-directed Medical Therapy
timeFrame: 90 days post enrollment
measure: Prescribing of Guideline-directed Medical Therapy
timeFrame: 180 days post enrollment
measure: Number of Subjects Using Guideline-directed Medical Therapy at 90 Days Post Enrollment
timeFrame: 90 days post enrollment
measure: Number of Subjects Using Guideline-directed Medical Therapy at 180 Days Post Enrollment
timeFrame: 180 days post enrollment
measure: Number of Participants With Emergency Department (ED) Visits at 90 Days Post Enrollment
timeFrame: 90 days post enrollment
measure: Number of Participants With Emergency Department Visits at 180 Days Post Enrollment
timeFrame: 180 days post enrollment
measure: Number of Participants With Acute Kidney Injury (AKI) Development at 90 Days Post Enrollment
timeFrame: 90 days post enrollment
measure: Number of Participants With Acute Kidney Injury (AKI) Development at 180 Days Post Enrollment
timeFrame: 180 days post enrollment
measure: Mortality Rate at 90 Days Post Enrollment
timeFrame: 90 days post enrollment
measure: Mortality Rates at 180 Days Post Enrollment
timeFrame: 180 days post enrollment
measure: Number of Participants With at Least One Clinic No-show at 90 Days Post Enrollment
timeFrame: 90 days post enrollment
measure: Number of In-person and Remote Clinic Visits at 90 Days Post Enrollment
timeFrame: 90 days post enrollment
measure: Number of In-person and Remote Clinic Visits at 180 Days Post Enrollment
timeFrame: 180 days post enrollment
measure: Number of Remote Device Checks by Providers at 90 Days Post Enrollment
timeFrame: 90 days post enrollment
measure: Number of Remote Device Checks by Providers at 180 Days Post Enrollment
timeFrame: 180 days post enrollment
measure: Number of Phone Calls Between Provider and Participant at 90 Days Post Enrollment
timeFrame: 90 days post enrollment
measure: Number of Phone Calls Between Provider and Participant at 180 Days Post Enrollment
timeFrame: 180 days post enrollment
measure: Average Time Devoted by Provider to Patient Care
timeFrame: 90 days post enrollment
measure: Average Time Devoted by Provider to Patient Care
timeFrame: 180 days post enrollment
measure: Number of Subjects Who Complete on Boarding and Baseline Assessments
timeFrame: Within one week of consent
measure: Number of Subjects Who Complete Digital Health Product Set up
timeFrame: 90 days post enrollment
measure: Number of Weekly Interactions With the Device
timeFrame: 90 days post enrollment
measure: Number of Weekly Interactions With the Device
timeFrame: 180 days post enrollment
measure: Average Number of Daily Interactions With the Device
timeFrame: 90 days post enrollment
measure: Average Number of Daily Interactions With the Device
timeFrame: 180 days post enrollment
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
Study officials:
affiliation: Yale University
name: Francis P Wilson, MD MSCE
role: PRINCIPAL_INVESTIGATOR
References: