NCT04394754

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 182 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Congestive Heart Failure

Interventions

Type	Name	Description
DEVICE	BodyPort	Patients will receive BodyPort, a smart scale that provides advanced cardiac monitoring.
OTHER	Noom	Patients will receive a subscription to use Noom, a personalized diet and weight management application.
OTHER	Conversa	patients will receive a subscription to use Conversa, a personalized automated coaching and motivational application.

Timeline

• Start date: 2020-09-21
• Primary completion: 2021-09-20
• Completion: 2021-12-01
• First posted: 2020-05-19
• Last updated: 2023-05-18
• Results posted: 2022-12-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study