Eat Well for Heart Failure
Eat Well Produce Prescription for Duke Health Patients With Congestive Heart Failure
This trial tests whether providing produce prescriptions plus different levels of nutritional coaching helps Duke Health patients with congestive heart failure stay healthier and use less health care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 900 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Duke University Academic / other |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT07101289 on ClinicalTrials.gov |
What this trial studies
This is a pragmatic, parallel three-arm randomized trial conducted at Duke Health that compares a produce prescription program delivered with minimal behavioral support, the same program with intensified behavioral support, and usual care. Interventions include prescription produce distributions and personal health planning with virtual nutritional coaching. Participants are adults with congestive heart failure who had a hospitalization or ED visit in the past 12 months and are at risk of food insecurity or are Medicaid/dual eligible. Outcomes include patient health measures, health care utilization and costs, and identification of barriers and facilitators to implementing the program.
Who should consider this trial
Good fit: Adults (18+) with a diagnosis of congestive heart failure who had a hospitalization or emergency visit in the past 12 months and are at risk of food insecurity or are Medicaid/dual eligible, who prefer English, have a valid email, and an NC mailing address.
Not a fit: Patients receiving dialysis or with end-stage renal disease, those with an LVAD or heart transplant, people unable to participate in English or without a North Carolina mailing address or email are unlikely to benefit from this program.
Why it matters
Potential benefit: If successful, the program could improve nutrition, reduce hospital readmissions, and lower health care costs for patients with heart failure.
How similar studies have performed: Other 'Food is Medicine' produce prescription programs have improved diet and food security in prior studies, but evidence specifically showing improved heart failure outcomes is limited, so this application to CHF is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Durham, North Carolina
- Duke Health — Durham, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Connor Drake, PhD — Duke Health
- Study coordinator: Connor Drake, PhD
- Email: connor.drake@duke.edu
- Phone: 919-724-2129
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.