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Cardiac Recovery Through Dietary Support (CaRDS)

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ClinicalTrials.gov Identifier: NCT03759925
Recruitment Status : Active, not recruiting
First Posted : November 30, 2018
Last Update Posted : October 6, 2020
Sponsor:
Collaborators:
San Francisco Department of Public Health
San Francisco General Hospital
Project Open Hand
Information provided by (Responsible Party):
University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
Heart Failure Other: Nutritional Support Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: We aim to randomize 180 participants to the intervention (n=90) or control (n=90) groups. 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.
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: The analyst(s) and investigator(s) conducting the analyses of the data will be masked to whether participants were in the intervention or control arm.
Primary Purpose: Other
Official Title: Food as Medicine: Providing Medically Appropriate Meals to Patients After Discharge for Congestive Heart Failure Exacerbation
Actual Study Start Date : April 5, 2017
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
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

No Intervention: Standard of Care
The control group will receive standard of care follow up care after their hospitalization for acute decompensated heart failure.



Primary Outcome Measures :
  1. Change in the Kansas City Cardiomyopathy Questionnaire (KCCQ) scores [ Time Frame: Assessed at time of enrollment and 1 and 5 months after hospital discharge. A subset of questions are asked at 3 and 4 months post discharge. ]
    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.


Secondary Outcome Measures :
  1. Admissions to Zuckerberg San Francisco General Hospital [ Time Frame: 3 months prior to randomization into study. Also assessed the following time periods after discharge: 30 days, 60 days, 90 days, 5 months, 6 months, and 9 months ]
    Number of admissions to Zuckerberg San Francisco General Hospital as determined by EHR

  2. Admissions to hospitals [ Time Frame: 3 months prior to randomization into study, 1 month after discharge, and 5 months after discharge ]
    Number of admissions to hospitals that is a composite of: participants' self-reporting of admission to hospitals OTHER than Zuckerberg San Francisco General Hospital and number of admissions to Zuckerberg San Francisco General as determined by EHR

  3. Emergency room utilization at Zuckerberg San Francisco General Hospital [ Time Frame: 3 months prior to randomization into study. Also assessed the following time periods after discharge: 30 days, 60 days, 90 days, 5 months, 6 months, and 9 months ]
    Number of ER visits at Zuckerberg San Francisco General Hospital as determined by EHR

  4. Emergency room utilization [ Time Frame: 3 months prior to randomization into study, 1 month after discharge, and 5 months after discharge ]
    Number of ER visits that is a composite of: participants' self-reporting of ER visits to hospitals OTHER than Zuckerberg San Francisco General Hospital and number of ER visits at Zuckerberg San Francisco General as determined by EHR

  5. Dietary behavior [ Time Frame: Assessed at time of enrollment as well as 1 month and 5 months after discharge ]
    Modified NCI Multifactor food frequency questionnaire that asks for self reported frequency of consumption of a number of food items in the prior month. Data can be scored to assess for percent energy from fat and fiber as well as servings of fruits and vegetables.

  6. Medication adherence by Visual Analog Scale [ Time Frame: Assessed at time of enrollment as well as 1 month and 5 months after discharge ]
    Self reported medication adherence in the month prior using a Visual Analog Scale that asks respondents to indicate a percentage to indicate how often they took their medications as the doctor prescribed. Respondent chooses on scale from 0% to 100% to indicate how often they took their medications in the last month.

  7. Medication adherence by MMAS-4 [ Time Frame: Assessed at time of enrollment as well as 1 month and 5 months after discharge ]
    Scores on the 4-item Morisky Medication Adherence Scale that scores responses into 3 categories: High, Medium, and Low Adherence

  8. Measure of Quality of life [ Time Frame: Assessed at time of enrollment as well as 1 month, 3 months, 4 months, and 5 months after discharge ]
    Self reported quality of life using the 4-item Healthy Days Core Module of the CDC's Health-Related Quality of Life survey which asks a general assessment of health on a 5-point Likert scale as well as 3 questions quantifying the number of days in the past 30 days participants felt their health was not good.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03759925


Locations
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United States, California
Zuckerberg San Francisco General
San Francisco, California, United States, 94110
Sponsors and Collaborators
University of California, San Francisco
San Francisco Department of Public Health
San Francisco General Hospital
Project Open Hand
Investigators
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Principal Investigator: 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
Publications:
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

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03759925    
Other Study ID Numbers: 16-20742
First Posted: November 30, 2018    Key Record Dates
Last Update Posted: October 6, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases