Eat Well Heart Failure
Recruiting · NCT07101289 · Interventional (participants receive a specific treatment) · Lead sponsor: Duke University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is 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.
Who can take part
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.
Where it is running
1 location listed across 1 US state.
- Duke Health - Durham, North Carolina, United States