Eat Well Heart Failure
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Personal health planning and nutritional coaching, Prescription Produce.
- Who it may be relevant to
- Registry conditions: Congestive Heart Failure Chronic. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Eat Well Produce Prescription for Duke Health Patients With Congestive Heart Failure
Overview
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.
Interventions
- Behavioral Personal health planning and nutritional coaching
Behavioral support will be offed by ZealCare, an evidence-based, virtual coaching behavioral support program for patients with chronic conditions. - Other Prescription Produce
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.
Primary outcome measures
- Composite of incidence rates of ED visits, hospitalizations, and all-cause mortality at 12 months [Time frame: 12 months]
Secondary outcome measures (10)
- All cause hospitalizations [Time frame: 12 months]
- All cause ED visits [Time frame: 12 months]
- Outpatient utilization [Time frame: 12 months]
- Change in Blood pressure [Time frame: 12 months]
- Change in Body Mass Index [Time frame: 12 months]
- Heart Failure Specific Hospitalization [Time frame: 12 months]
- Heart Failure specific Emergency Department use [Time frame: 12 months]
- Kansas City Cardiomyopathy Questionnaire 12-item version (KCCQ-12) [Time frame: Baseline, 6 months, and 12 months]
- USDA 6-item Food Security Survey Module (FSSM) [Time frame: Baseline, 6 months, and 12 months]
- Dietary Screener Questionnaire (DSQ) [Time frame: Baseline, 6 months, and 12 months.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Duke Health — Durham
Identifiers
NCT: NCT07101289 · PRO00117602