Cardiac Recovery Through Dietary Support (CaRDS)
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About
This is a prospective, randomized, wait-list controlled study examining the impact of providing medically appropriate meals to patients discharged from Zuckerberg San Francisco General Hospital after acute decompensated heart failure. Upon discharge, patients will be randomized to either the intervention or wait list control arm. The intervention is the delivery of medically appropriate meals and groceries to patients' homes in a tapered manner over five months (the equivalent of three meals a day for 60 days, then the equivalent of two meals a day for 30 days, then the equivalent of one meal a day for 60 days) and monthly assessments with a registered dietician (RD). All food and RD assessments are administered via a community partner, Project Open Hand, as a modification of current offerings for clients at Project Open Hand. Subjects randomized into the wait list control arm will receive the food intervention five months after discharge. The study's primary aim is to examine the impact of nutritional support on the Kansas City Cardiomyopathy Questionnaire scores. In addition, the study aims to examine the impact of nutritional support on healthcare utilization (particularly readmission rates and emergency room utilization), dietary change, medication adherence, and quality of life.
Full description
The San Francisco Department of Public Health, University of California at San Francisco (UCSF), and Project Open Hand (POH), a community based organization in San Francisco which provides meals and groceries to chronically ill clients in the Bay Area, have partnered to conduct a prospective, randomized, wait-list controlled study examining the impact of providing medically appropriate meals and registered dietician (RD) support to patients discharged from Zuckerberg San Francisco General Hospital after acute decompensated heart failure. Before discharge, patients will be randomized to either the intervention or wait list control arm. The intervention consists of the delivery of medically appropriate meals and/or groceries to participants' homes in a tapered manner over five months (the equivalent of three meals a day for 60 days, then the equivalent of two meals a day for 30 days, then the equivalent of one meal a day for 60 days) and monthly nutrition education with a registered dietician (RD). All food and nutritional education are administered by POH staff and RDs. Participants randomized into the wait list control arm will receive the food intervention five months after discharge. The study's primary aim is to examine the impact of nutritional support on the Kansas City Cardiomyopathy Questionnaire scores. In addition, the study aims to examine the impact of nutritional support on healthcare utilization (particularly readmission rates and emergency room utilization), dietary change, medication adherence, and quality of life. The investigators will assess outcomes at baseline while patients are hospitalized, 1 month after discharge, and 5 months after discharge using quantitative surveys. The investigators will call participants at 3 months and 4 months after discharge with a shorter quantitative survey assessing a subset of outcome measures. In addition, the investigators will conduct a qualitative interview near the conclusion of the intervention in a subset of participants to understand perceived impacts of the intervention as well as barriers and facilitators to heart failure care.
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Inclusion criteria
- Adults hospitalized at Zuckerberg San Francisco General Hospital (ZSFG) with acute decompensated heart failure/congestive heart failure exacerbation
- Adults with their primary residence within San Francisco
- Age: >18 years old
- Languages: English or Spanish
- Housed at a location where they would be able to securely receive, store and reheat food
Exclusion criteria
- Patients with severe or critical aortic stenosis.
- Patients with six or more hospital admissions within the last twelve months
- Patients who are being discharged to a living facility that provides meals to residents.
- Patients who anticipate moving from their current housing situation to one that does not meet our inclusion criteria within six months of enrollment.
- Patients who are part of meal provision program that provides more than 7 meals a week to the patient.
- Patients who are unable to feed themselves and do not have adequate support to help them with feeding.
- Patients with limited physical, cognitive, or behavioral abilities that would interfere with their ability to follow-up with a study as determined by their ability to receive the Project Open Hand services and follow up with survey interviews
- Patients with anticipated life expectancy of less than a year.
- Patients who lack capacity to consent to a research study.
- Patients currently requiring dialysis or determined to be in need of dialysis in the next 6 months.
- Patients with severe allergies to eggs, soy, wheat, nuts, seeds, seed oils, pineapple, raisins, or certain vegetables such as onions (allergies are considered on a case-by-case basis in consultation with Project Open Hand).
Trial design
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Interventional model
Masking
192 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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