Evaluating Efficacy of Digital Health Technology in the Treatment of Congestive Heart Failure
Condition: Congestive Heart Failure
MeSH terms: Heart Failure
Study type: Interventional

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.
    

Intervention name(s): BodyPort; Noom; Conversa
Intervention type(s): Device; Other; Other
Intervention description(s): Patients will receive BodyPort, a smart scale that provides advanced cardiac monitoring.; Patients will receive a subscription to use Noom, a personalized diet and weight management application.; patients will receive a subscription to use Conversa, a personalized automated coaching and motivational application.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Digital Health