N/A N=182 Randomized Single-blind Supportive Care

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

Congestive Heart Failure

Bottom Line

View on ClinicalTrials.gov: NCT04394754 ↗

Enrolled (actual)

182

Serious AEs

0.0%

Results posted

Dec 2022

Primary outcome: Primary: Change in Quality of Life at 90 Days Post Enrollment — -4.2; -4.2; 0; -4.2 Scores on a scale (difference)

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: BodyPort (Device); Noom (Other); Conversa (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Yale University
Primary completion: Sep 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Quality of Life at 90 Days Post Enrollment	-4.2; -4.2; 0; -4.2; 0; 0	—
SECONDARY Change in Quality of Life at 180 Days Post Enrollment	-4.2; -8.3; -2.1; -2.1; 0; 0	—
SECONDARY Number of Participants With Hospital Admission at 90 Days Post Enrollment	11; 16; 14; 17; 4; 6	—
SECONDARY Number of Participants With Hospital Admission at 180 Days Post Enrollment	10; 15; 15; 14; 3; 5	—
SECONDARY Prescribing of Guideline-directed Medical Therapy	—	—
SECONDARY Prescribing of Guideline-directed Medical Therapy	—	—
SECONDARY Number of Subjects Using Guideline-directed Medical Therapy at 90 Days Post Enrollment	42; 39; 41; 42; 32; 36	—
SECONDARY Number of Subjects Using Guideline-directed Medical Therapy at 180 Days Post Enrollment	40; 38; 40; 40; 34; 35	—
SECONDARY Number of Participants With Emergency Department (ED) Visits at 90 Days Post Enrollment	10; 12; 10; 14; 4; 3	—
SECONDARY Number of Participants With Emergency Department Visits at 180 Days Post Enrollment	8; 12; 13; 13; 4; 3	—
SECONDARY Number of Participants With Acute Kidney Injury (AKI) Development at 90 Days Post Enrollment	4; 6; 2; 6	—
SECONDARY Number of Participants With Acute Kidney Injury (AKI) Development at 180 Days Post Enrollment	3; 2; 3; 3	—
SECONDARY Mortality Rate at 90 Days Post Enrollment	0; 0; 0; 1	—
SECONDARY Mortality Rates at 180 Days Post Enrollment	1; 2; 0; 1	—
SECONDARY Number of Participants With at Least One Clinic No-show at 90 Days Post Enrollment	12; 12; 8; 10	—
SECONDARY Number of In-person and Remote Clinic Visits at 90 Days Post Enrollment	2; 2; 2; 2; 1; 1	—
SECONDARY Number of In-person and Remote Clinic Visits at 180 Days Post Enrollment	1; 0; 1; 0; 0; 0	—
SECONDARY Number of Remote Device Checks by Providers at 90 Days Post Enrollment	17; 1; 3; 6	—
SECONDARY Number of Remote Device Checks by Providers at 180 Days Post Enrollment	0; 0; 0; 0	—
SECONDARY Number of Phone Calls Between Provider and Participant at 90 Days Post Enrollment	1; 1; 1; 2; 2; 2	—
SECONDARY Number of Phone Calls Between Provider and Participant at 180 Days Post Enrollment	0; 0; 0; 0; 0; 0	—
SECONDARY Average Time Devoted by Provider to Patient Care	—	—
SECONDARY Average Time Devoted by Provider to Patient Care	—	—
SECONDARY Number of Subjects Who Complete on Boarding and Baseline Assessments	44; 46; 46; 46	—
SECONDARY Number of Subjects Who Complete Digital Health Product Set up	43; 23; 33	—
SECONDARY Number of Weekly Interactions With the Device	6; 6.5; 1; 6.9; 5.8; 1	—
SECONDARY Number of Weekly Interactions With the Device	6; 6.5; 1; 6.9; 5.8; 1	—
SECONDARY Average Number of Daily Interactions With the Device	.6; .9; .2	—
SECONDARY Average Number of Daily Interactions With the Device	.6; .9; .2	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04394754). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.