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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
900
Behavioral support will be offed by ZealCare, an evidence-based, virtual coaching behavioral support program for patients with chronic conditions.
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.
Duke Health
Durham, North Carolina, United States
RECRUITINGComposite of incidence rates of ED visits, hospitalizations, and all-cause mortality at 12 months
The primary outcome of interest will be a composite endpoint of: ED visits, hospitalizations, and all-cause mortality at 12 months.
Time frame: 12 months
All cause hospitalizations
The total number of admissions to a hospital for any reason
Time frame: 12 months
All cause ED visits
The total number of visits to the Emergency Department for any reason
Time frame: 12 months
Outpatient utilization
The number of outpatient visits
Time frame: 12 months
Change in Blood pressure
Change in Blood Pressure from baseline to visit closest to end of study assessed by both systolic and diastolic blood pressure
Time frame: 12 months
Change in Body Mass Index
Change in Body Mass Index from baseline to visit closest to end of study
Time frame: 12 months
Heart Failure Specific Hospitalization
Hospitalization related to heart failure.
Time frame: 12 months
Heart Failure specific Emergency Department use
Visits to the emergency department related to heart failure
Time frame: 12 months
Kansas City Cardiomyopathy Questionnaire 12-item version (KCCQ-12)
The Kansas City Cardiomyopathy Questionnaire 12-item version (KCCQ-12) is a validated, self-administered health status measure for patients with heart failure. It is designed to quantify the patient's perception of their health status related to heart failure over the past two weeks. Scoring Range: Each domain score and the overall/clinical summary scores are transformed to a standardized range of 0 to 100. Interpretation: Higher scores indicate better health status and outcomes, while lower scores indicate worse health status and more severe limitations. 0-24: Very poor to poor health 25-49: Poor to fair health 50-74: Fair to good health 75-100: Good to excellent health
Time frame: Baseline, 6 months, and 12 months
USDA 6-item Food Security Survey Module (FSSM)
The USDA 6-item Food Security Survey Module (FSSM) is a short form of the larger 18-item survey, designed to efficiently assess and categorize a household's food security status. The scale is based on the number of affirmative (food-insecure) responses, with a raw score range of 0 to 6. A higher score indicates a worse outcome (greater food insecurity/less food security), while a lower score indicates a better outcome (higher food security).
Time frame: Baseline, 6 months, and 12 months
Dietary Screener Questionnaire (DSQ)
The 10-item DSQ assesses the frequency of fruit and vegetable intake. Higher scores on beneficial foods (like fruits and vegetables) mean a better outcome (healthier diet). Higher scores on less healthy items (like added sugars or red/processed meat) would mean a worse outcome.
Time frame: Baseline, 6 months, and 12 months.
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