Cardiac Recovery Through Dietary Support

NCT ID: NCT03759925

Last Updated: 2022-04-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 192 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-05
• Study Completion Date: 2021-07-06

Brief 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.

Detailed 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.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Nutritional Support

The intervention consists of home delivery of medically-appropriate food support (DASH and diabetic diet compliant) in the form of prepared meals and/or groceries and monthly individual nutritional counseling with a Registered Dietician.

Group Type: EXPERIMENTAL

Nutritional Support

Intervention Type: OTHER

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

Standard of Care

The control group will receive standard of care follow up care after their hospitalization for acute decompensated heart failure.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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

• 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).

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

San Francisco Department of Public Health

OTHER_GOV

Sponsor Role: collaborator

San Francisco General Hospital

OTHER

Sponsor Role: collaborator

Project Open Hand

OTHER

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rita Nguyen, MD

Role: PRINCIPAL_INVESTIGATOR

San Francisco Department of Public Health, UCSF

Sheri Weiser, MD, MPH, MA

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Kartika Palar, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Binh An Phan, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

Zuckerberg San Francisco General

San Francisco, California, United States

Countries

United States

References

Campbell AD, Godfryd A, Buys DR, Locher JL. Does Participation in Home-Delivered Meals Programs Improve Outcomes for Older Adults? Results of a Systematic Review. J Nutr Gerontol Geriatr. 2015;34(2):124-67. doi: 10.1080/21551197.2015.1038463.

Reference Type: BACKGROUND

PMID: 26106985 (View on PubMed)

Ford ES. Food security and cardiovascular disease risk among adults in the United States: findings from the National Health and Nutrition Examination Survey, 2003-2008. Prev Chronic Dis. 2013 Dec 5;10:E202. doi: 10.5888/pcd10.130244.

Reference Type: BACKGROUND

PMID: 24309090 (View on PubMed)

Gurvey J, Rand K, Daugherty S, Dinger C, Schmeling J, Laverty N. Examining health care costs among MANNA clients and a comparison group. J Prim Care Community Health. 2013 Oct;4(4):311-7. doi: 10.1177/2150131913490737. Epub 2013 Jun 3.

Reference Type: BACKGROUND

PMID: 23799677 (View on PubMed)

Seligman HK, Jacobs EA, Lopez A, Tschann J, Fernandez A. Food insecurity and glycemic control among low-income patients with type 2 diabetes. Diabetes Care. 2012 Feb;35(2):233-8. doi: 10.2337/dc11-1627. Epub 2011 Dec 30.

Reference Type: BACKGROUND

PMID: 22210570 (View on PubMed)

Seligman HK, Lyles C, Marshall MB, Prendergast K, Smith MC, Headings A, Bradshaw G, Rosenmoss S, Waxman E. A Pilot Food Bank Intervention Featuring Diabetes-Appropriate Food Improved Glycemic Control Among Clients In Three States. Health Aff (Millwood). 2015 Nov;34(11):1956-63. doi: 10.1377/hlthaff.2015.0641.

Reference Type: BACKGROUND

PMID: 26526255 (View on PubMed)

Weiser SD, Hatcher A, Frongillo EA, Guzman D, Riley ED, Bangsberg DR, Kushel MB. Food insecurity is associated with greater acute care utilization among HIV-infected homeless and marginally housed individuals in San Francisco. J Gen Intern Med. 2013 Jan;28(1):91-8. doi: 10.1007/s11606-012-2176-4. Epub 2012 Aug 18.

Reference Type: BACKGROUND

PMID: 22903407 (View on PubMed)

Zilak, J.P. & Gunderson, C. (2014). The health consequences of senior hunger in the United States: Evidence from the 1999-2010 NHANES. Retrieved from: http://www.humsenior.org/dmdocuments/Senior%20Hunger_article.pdf?lbisphpreq=1

Reference Type: BACKGROUND

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

16-20742

Identifier Type: -

Identifier Source: org_study_id