Duke Health
Durham, North Carolina, 27701, United States
Location status: Recruiting
NCT Number: NCT07101289
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Durham, North Carolina, 27701, United States
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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
Exclusion criteria
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.
Other names: Eat Well
Time frame: 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
The total number of admissions to a hospital for any reason
Time frame: 12 months
The total number of visits to the Emergency Department for any reason
Time frame: 12 months
The number of outpatient visits
Time frame: 12 months
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 from baseline to visit closest to end of study
Time frame: 12 months
Hospitalization related to heart failure.
Time frame: 12 months
Visits to the emergency department related to heart failure
Time frame: Baseline, 6 months, and 12 months
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
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.
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.
Contact information is provided by the study sponsor or research team.
Cierra Buckman, MHS
CONTACT
Connor Drake, PhD
CONTACT
Duke University
Other
Eat Well Produce Prescription for Duke Health Patients With Congestive Heart Failure
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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