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

NCT ID: NCT04394754

Last Updated: 2023-05-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 182 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-21
• Study Completion Date: 2021-12-01

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.

Conditions

Congestive Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Control

Patients will receive usual care and no digital health device.

Group Type: NO_INTERVENTION

No interventions assigned to this group

BodyPort

Patients will receive the BodyPort device.

Group Type: EXPERIMENTAL

BodyPort

Intervention Type: DEVICE

Patients will receive BodyPort, a smart scale that provides advanced cardiac monitoring.

Noom

Patients will receive a subscription to the Noom platform.

Group Type: EXPERIMENTAL

Noom

Intervention Type: OTHER

Patients will receive a subscription to use Noom, a personalized diet and weight management application.

Conversa

Patients will receive a subscription to the Conversa platform.

Group Type: EXPERIMENTAL

Conversa

Intervention Type: OTHER

patients will receive a subscription to use Conversa, a personalized automated coaching and motivational application.

Interventions

BodyPort

Patients will receive BodyPort, a smart scale that provides advanced cardiac monitoring.

Intervention Type: DEVICE

Noom

Patients will receive a subscription to use Noom, a personalized diet and weight management application.

Intervention Type: OTHER

Conversa

patients will receive a subscription to use Conversa, a personalized automated coaching and motivational application.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: collaborator

ZS

INDUSTRY

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Francis P Wilson, MD MSCE

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale New Haven Hospital

New Haven, Connecticut, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 37943227 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2000027325

Identifier Type: -

Identifier Source: org_study_id