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

NCT04394754 | Completed Results FDA Device

• 1 other identifier: 2000027325
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 1

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.

Conditions

Congestive Heart Failure

Keywords

Digital Health

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (28)

• Change in Quality of Life at 180 Days Post Enrollment

  180 days post enrollment

• Number of Participants With Hospital Admission at 90 Days Post Enrollment

  90 days post enrollment

• Number of Participants With Hospital Admission at 180 Days Post Enrollment

  180 days post enrollment

• Prescribing of Guideline-directed Medical Therapy

  90 days post enrollment

• Prescribing of Guideline-directed Medical Therapy

  180 days post enrollment

Study Arms (4)

Control

NO INTERVENTION

Patients will receive usual care and no digital health device.

BodyPort

EXPERIMENTAL

Patients will receive the BodyPort device.

Device: BodyPort

Noom

EXPERIMENTAL

Patients will receive a subscription to the Noom platform.

Other: Noom

Conversa

EXPERIMENTAL

Patients will receive a subscription to the Conversa platform.

Other: Conversa

Interventions

BodyPort DEVICE

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

BodyPort

Noom OTHER

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

Noom

Conversa OTHER

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

Conversa

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• Boehringer Ingelheim: collaborator
• ZS: collaborator

Study Sites (1)

Yale New Haven Hospital

New Haven, Connecticut, 06520, United States

Location

Related Publications (1)

• 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.

  PMID: 37943227 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Limitations and Caveats

* Exclusion of patients over 80 years of age, which could intrinsically bias the trial towards those with more digital literacy. * A proportion of participants randomized to each of the groups that decided not to use the technology during their follow-up period. Our intention to treat analysis sought to evaluate real-world use and applicability. * The study was conducted across eleven outpatient HF clinics within a large health system in CT, USA, which could limit generalizability.

Results Point of Contact

• Title: Francis Perry Wilson
• Organization: Yale University

francis.p.wilson@yale.edu

203-737-1704

Study Officials

• Francis P Wilson, MD MSCE

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2020
• First Posted: May 19, 2020
• Study Start: September 21, 2020
• Primary Completion: September 20, 2021
• Study Completion: December 1, 2021
• Last Updated: May 18, 2023
• Results First Posted: December 23, 2022

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Upon publication; indefinitely

Locations

US (1)