Cardiac Recovery Through Dietary Support



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:12/2/2018
Start Date:April 5, 2017
End Date:February 2020
Contact:Rita Nguyen, MD
Email:rita.nguyen@sfdph.org
Phone:415-437-6244

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Food as Medicine: Providing Medically Appropriate Meals to Patients After Discharge for Congestive Heart Failure Exacerbation

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.

The San Francisco Department of Public Health, 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, 2 months 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.

Inclusion Criteria:

- Adults hospitalized at 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).
We found this trial at
1
site
1001 Potrero Avenue
San Francisco, California 94110
Phone: 415-437-6244
?
mi
from
San Francisco, CA
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