Cardiac Recovery Through Dietary Support

NCT03759925 | Completed

• 1 other identifier: 16-20742
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (6)

• Change in the overall Kansas City Cardiomyopathy Questionnaire (KCCQ) scores from baseline to one month by study arm

  The Kansas City Cardiomyopathy Questionnaire is a 23-item instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. An overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.The change in the overall score from baseline to one month will be reported.

  Baseline and one month

• Change in the overall Kansas City Cardiomyopathy Questionnaire (KCCQ) scores from baseline to five months by study arm

  The Kansas City Cardiomyopathy Questionnaire is a 23-item instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. An overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. The change in the overall score from baseline to five months will be reported.

  Baseline and five months

• Change in the clinical summary Kansas City Cardiomyopathy Questionnaire (KCCQ) scores from baseline to one month by study arm

  The Kansas City Cardiomyopathy Questionnaire is a 23-item instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. A clinical summary score can be obtained from the symptom frequency and burden domains and the physical limitation domain. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.The change in the clinical summary score from baseline to one month will be reported by study arm.

  Baseline and one month

• Change in the clinical summary Kansas City Cardiomyopathy Questionnaire (KCCQ) scores from baseline to five months by study arm

  The Kansas City Cardiomyopathy Questionnaire is a 23-item instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. A clinical summary score can be obtained from the symptom frequency and burden domains and the physical limitation domain. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.The change in the clinical summary score from baseline to five months will be reported by study arm.

  Baseline and five months

• Change in the physical domain Kansas City Cardiomyopathy Questionnaire (KCCQ) scores from baseline to one month by study arm

  The Kansas City Cardiomyopathy Questionnaire is a 23-item instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. Scores from the physical domain can be transformed to 0 to 100 , in which higher scores reflects better health status.The change in the physical domain score from baseline to one month will be reported by study arm.

  Baseline and one month

• Change in the physical domain Kansas City Cardiomyopathy Questionnaire (KCCQ) scores from baseline to five months by study arm

  The Kansas City Cardiomyopathy Questionnaire is a 23-item instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. Scores from the physical domain can be transformed to 0 to 100 , in which higher scores reflects better health status.The change in the physical domain score from baseline to five months will be reported by study arm.

  Baseline and five months

Secondary Outcomes (11)

• Hospital admissions from baseline to 1 month, by study arm

  Baseline and 1 month

• Hospital admissions from baseline to 5 month, by study arm

  Baseline and 5 months

• Emergency room utilization at any hospital from baseline to 1 month, by study arm.

  Baseline and 1 month

• Emergency room utilization at any hospital from baseline to 5 month, by study arm.

  Baseline and 5 months

• Change in overall health-related quality of life from baseline to five months, by study arm

  Baseline and five months

Other Outcomes (2)

• Hospital admissions to Zuckerberg San Francisco General Hospital from baseline to nine months, by study arm

  Baseline and nine months

• Emergency room utilization utilization at Zuckerberg San Francisco General Hospital from baseline to nine months by study arm

  Baseline and nine months

Study Arms (2)

Nutritional Support

EXPERIMENTAL

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.

Other: Nutritional Support

Standard of Care

NO INTERVENTION

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

Interventions

Nutritional Support 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

Nutritional Support

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 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).

Sponsors & Collaborators

• University of California, San Francisco: lead
• San Francisco Department of Public Health: collaborator
• San Francisco General Hospital: collaborator
• Project Open Hand: collaborator

Study Sites (1)

Zuckerberg San Francisco General

San Francisco, California, 94110, United States

Location

Related Publications (7)

• 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.

  PMID: 26106985 BACKGROUND

• 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.

  PMID: 24309090 BACKGROUND

• 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.

  PMID: 23799677 BACKGROUND

• 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.

  PMID: 22210570 BACKGROUND

• 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.

  PMID: 26526255 BACKGROUND

• 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.

  PMID: 22903407 BACKGROUND

• 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

  BACKGROUND

MeSH Terms

Conditions

Heart Failure

Interventions

Nutritional Support

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• Rita Nguyen, MD

  San Francisco Department of Public Health, UCSF

  PRINCIPAL INVESTIGATOR

• Sheri Weiser, MD, MPH, MA

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Kartika Palar, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Binh An Phan, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The principal investigators will be masked to whether participants were in the intervention or control arm.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 180 participants will be randomized to the intervention (n=90) or control (n=90) groups, stratified by health care utilization (\<3 vs. \>=3 hospital admissions at ZSFGH) and food security ( zero affirmative answers vs. at least one affirmative answers on the US Department of Agriculture (USDA) 12-question food security screener). The intervention consists of providing home delivery of medically-appropriate food support and individual nutritional counseling over five months to patients at Zuckerberg San Francisco General admitted to the hospital with acute decompensated heart failure.

Study Record Dates

• First Submitted: November 29, 2018
• First Posted: November 30, 2018
• Study Start: April 5, 2017
• Primary Completion: September 28, 2020
• Study Completion: July 6, 2021
• Last Updated: April 5, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)