Eat Well Heart Failure

Duke University

Status: Enrolling

Conditions: Congestive Heart Failure Chronic

Treatments: Behavioral: Personal health planning and nutritional coaching; Other: Prescription Produce

Study type: Interventional

Funder types: Other

Identifiers

NCT07101289

PRO00117602

Details and patient eligibility

About

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.

Enrollment: 900 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18 or older
• Diagnosis of CHF regardless of ejection fraction AND
• Hospitalization or ED visit within the past 12 months AND
• At risk of food insecurity as defined by one of the following:

screened positive for financial instability (medium risk and up) or food insecurity in the past 12 months minimum OR a Medicaid or dual eligible enrollee

• English as preferred language
• Valid email address (for virtual health coaching intervention)
• NC mailing address

Exclusion criteria

• History of dialysis or end stage renal disease OR
• History of LVAD or heart transplant.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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900 participants in 3 patient groups

Usual Care

No Intervention group

Description:

Patients will continue to receive their usual care as well as educational materials

Prescription Produce program with low behavioral support

Active Comparator group

Description:

Patients will receive the Eat Well Prescription Produce benefit card ($100/month for 12 months) with low behavioral support provided by Reinvestment Partners

Treatment:

Other: Prescription Produce

Prescription Produce program with high behavioral support

Active Comparator group

Description:

Patients will receive the Eat Well Prescription produce benefit card ($100/month for 12 months) with high behavioral support provided by Reinvestment Partners and ZealCare

Treatment:

Other: Prescription Produce

Behavioral: Personal health planning and nutritional coaching