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
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
Treatments tested in this trial
- Personal health planning and nutritional coaching
- Prescription Produce
Treatment groups
900 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov