Cardiac Recovery Through Dietary Support

Summary

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.

Conditions

• Heart Failure

Interventions

OTHER

Nutritional Support

Weekly nutritional components: Month 1: equivalent of 3 meals/day in the form of 14 frozen meals, and breakfast bag with items to prepare 7 breakfast meals. Month 2: equivalent of 3 meals a day in the form of 7 frozen meals, grocery bags, and breakfast bags with items to prepare 7 breakfast meals. Month 3: the equivalent of 2 meals a day in the form of 7 frozen meals and grocery bags. Month 4: Participant choice to receive either 7 frozen meals or grocery bag with equivalent food for 1 meal a day. Month 5: Grocery bag with equivalent food for 1 meal a day Nutritional counseling component: Individual counseling with Registered Dietician monthly

Sponsors & Collaborators

• San Francisco Department of Public Health

  collaborator OTHER_GOV

• San Francisco General Hospital

  collaborator OTHER

• Project Open Hand

  collaborator OTHER

• University of California, San Francisco

  lead OTHER

Principal Investigators

• Rita Nguyen, MD · San Francisco Department of Public Health, UCSF

• Sheri Weiser, MD, MPH, MA · University of California, San Francisco

• Kartika Palar, PhD · University of California, San Francisco

• Binh An Phan, MD · University of California, San Francisco

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-04-05

Primary Completion

2020-09-28

Completion

2021-07-06

Countries

• United States

Study Locations