Health TrialsbyHealthPanel

Eat Well Heart Failure

ConditionCongestive Heart Failure Chronic
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDuke University

About this trial

The purpose of this parallel pragmatic randomized controlled trial (RCT) is to evaluate the impact of Eat Well (an evidence-based 'Food is Medicine' produce prescription program) with varying levels of behavioral support on health outcomes and care utilization patterns of Duke Health patients diagnosed with congestive heart failure (CHF). Objectives of this three arm trial include testing the effectiveness of Eat Well alone with minimal behavioral support and Eat Well with intensified behavioral support based on an evidence based approach to improve CHF patients' health outcomes, estimating health care cost savings between the intervention and control arms, and identifying barriers, facilitators, and potential strategies to enhance Eat Well effectiveness and implementation.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 or older

Diagnosis of CHF regardless of ejection fraction AND

Hospitalization or ED visit within the past 12 months AND

English as preferred language

Disqualifiers

History of dialysis or end stage renal disease OR

History of LVAD or heart transplant.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Personal health planning and nutritional coaching

    Behavioral

    Behavioral support will be offed by ZealCare, an evidence-based, virtual coaching behavioral support program for patients with chronic conditions.

  • Prescription Produce

    Other intervention

    Eat Well is a prescription produce program that provides a reloadable, restricted use debit card to participants to purchase fresh, frozen, or canned fruits, vegetables, and legumes at grocery stores.

Treatment groups

900 Participants
are divided into 3 treatment groups
Group A: Usual CareNo intervention 0 interventions
Group B: Prescription Produce program with low behavioral supportActive comparator 1 intervention
Group C: Prescription Produce program with high behavioral supportActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Composite of incidence rates of ED visits, hospitalizations, and all-cause mortality at 12 months

The primary outcome of interest will be a composite endpoint of: ED visits, hospitalizations, and all-cause mortality at 12 months.

Time frame
12 months

Secondary outcomes

1

All cause hospitalizations

The total number of admissions to a hospital for any reason

Time frame
12 months
2

All cause ED visits

The total number of visits to the Emergency Department for any reason

Time frame
12 months
3

Outpatient utilization

The number of outpatient visits

Time frame
12 months
4

Change in Blood pressure

Change in Blood Pressure from baseline to visit closest to end of study assessed by both systolic and diastolic blood pressure

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Duke University

Lead sponsor

Reinvestment Partners

Collaborator

ZealCare

Collaborator

Source ClinicalTrials.gov
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