Clinical Trial Radar

Composite 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.

12 months

All cause hospitalizations

The total number of admissions to a hospital for any reason

12 months

All cause ED visits

The total number of visits to the Emergency Department for any reason

12 months

Outpatient utilization

The number of outpatient visits

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

12 months

Change in Body Mass Index

Change in Body Mass Index from baseline to visit closest to end of study

12 months

Heart Failure Specific Hospitalization

Hospitalization related to heart failure.

12 months

Heart Failure specific Emergency Department use

Visits to the emergency department related to heart failure

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

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).

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.

Baseline, 6 months, and 12 months.