<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03759925</url>
  </required_header>
  <id_info>
    <org_study_id>16-20742</org_study_id>
    <nct_id>NCT03759925</nct_id>
  </id_info>
  <brief_title>Cardiac Recovery Through Dietary Support</brief_title>
  <acronym>CaRDS</acronym>
  <official_title>Food as Medicine: Providing Medically Appropriate Meals to Patients After Discharge for Congestive Heart Failure Exacerbation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>San Francisco Department of Public Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>San Francisco General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Project Open Hand</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, San Francisco</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective, randomized, wait-list controlled study examining the impact of&#xD;
      providing medically appropriate meals to patients discharged from Zuckerberg San Francisco&#xD;
      General Hospital after acute decompensated heart failure. Upon discharge, patients will be&#xD;
      randomized to either the intervention or wait list control arm. The intervention is the&#xD;
      delivery of medically appropriate meals and groceries to patients' homes in a tapered manner&#xD;
      over five months (the equivalent of three meals a day for 60 days, then the equivalent of two&#xD;
      meals a day for 30 days, then the equivalent of one meal a day for 60 days) and monthly&#xD;
      assessments with a registered dietician (RD). All food and RD assessments are administered&#xD;
      via a community partner, Project Open Hand, as a modification of current offerings for&#xD;
      clients at Project Open Hand. Subjects randomized into the wait list control arm will receive&#xD;
      the food intervention five months after discharge. The study's primary aim is to examine the&#xD;
      impact of nutritional support on the Kansas City Cardiomyopathy Questionnaire scores. In&#xD;
      addition, the study aims to examine the impact of nutritional support on healthcare&#xD;
      utilization (particularly readmission rates and emergency room utilization), dietary change,&#xD;
      medication adherence, and quality of life.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The San Francisco Department of Public Health, University of California at San Francisco&#xD;
      (UCSF), and Project Open Hand (POH), a community based organization in San Francisco which&#xD;
      provides meals and groceries to chronically ill clients in the Bay Area, have partnered to&#xD;
      conduct a prospective, randomized, wait-list controlled study examining the impact of&#xD;
      providing medically appropriate meals and registered dietician (RD) support to patients&#xD;
      discharged from Zuckerberg San Francisco General Hospital after acute decompensated heart&#xD;
      failure. Before discharge, patients will be randomized to either the intervention or wait&#xD;
      list control arm. The intervention consists of the delivery of medically appropriate meals&#xD;
      and/or groceries to participants' homes in a tapered manner over five months (the equivalent&#xD;
      of three meals a day for 60 days, then the equivalent of two meals a day for 30 days, then&#xD;
      the equivalent of one meal a day for 60 days) and monthly nutrition education with a&#xD;
      registered dietician (RD). All food and nutritional education are administered by POH staff&#xD;
      and RDs. Participants randomized into the wait list control arm will receive the food&#xD;
      intervention five months after discharge. The study's primary aim is to examine the impact of&#xD;
      nutritional support on the Kansas City Cardiomyopathy Questionnaire scores. In addition, the&#xD;
      study aims to examine the impact of nutritional support on healthcare utilization&#xD;
      (particularly readmission rates and emergency room utilization), dietary change, medication&#xD;
      adherence, and quality of life. The investigators will assess outcomes at baseline while&#xD;
      patients are hospitalized, 1 month after discharge, and 5 months after discharge using&#xD;
      quantitative surveys. The investigators will call participants at 3 months and 4 months after&#xD;
      discharge with a shorter quantitative survey assessing a subset of outcome measures. In&#xD;
      addition, the investigators will conduct a qualitative interview near the conclusion of the&#xD;
      intervention in a subset of participants to understand perceived impacts of the intervention&#xD;
      as well as barriers and facilitators to heart failure care.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 5, 2017</start_date>
  <completion_date type="Actual">July 6, 2021</completion_date>
  <primary_completion_date type="Actual">September 28, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>180 participants will be randomized to the intervention (n=90) or control (n=90) groups, stratified by health care utilization (&lt;3 vs. &gt;=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.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Investigator)</masking>
    <masking_description>The principal investigators will be masked to whether participants were in the intervention or control arm.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in the overall Kansas City Cardiomyopathy Questionnaire (KCCQ) scores from baseline to one month by study arm</measure>
    <time_frame>Baseline and one month</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in the overall Kansas City Cardiomyopathy Questionnaire (KCCQ) scores from baseline to five months by study arm</measure>
    <time_frame>Baseline and five months</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in the clinical summary Kansas City Cardiomyopathy Questionnaire (KCCQ) scores from baseline to one month by study arm</measure>
    <time_frame>Baseline and one month</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in the clinical summary Kansas City Cardiomyopathy Questionnaire (KCCQ) scores from baseline to five months by study arm</measure>
    <time_frame>Baseline and five months</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in the physical domain Kansas City Cardiomyopathy Questionnaire (KCCQ) scores from baseline to one month by study arm</measure>
    <time_frame>Baseline and one month</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in the physical domain Kansas City Cardiomyopathy Questionnaire (KCCQ) scores from baseline to five months by study arm</measure>
    <time_frame>Baseline and five months</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hospital admissions from baseline to 1 month, by study arm</measure>
    <time_frame>Baseline and 1 month</time_frame>
    <description>Number of admissions to hospitals that is a composite of: 1) At baseline, participants will self-report ER visits to hospitals OTHER than Zuckerberg San Francisco General Hospital in the past three months, and 2) the number of admissions to Zuckerberg San Francisco General will be determined by medical records. The number of hospital admissions from baseline to 1 month after discharge, by study arm will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital admissions from baseline to 5 month, by study arm</measure>
    <time_frame>Baseline and 5 months</time_frame>
    <description>Number of admissions to hospitals that is a composite of:1) At baseline, participants will self-report ER visits to hospitals OTHER than Zuckerberg San Francisco General Hospital in the past three months, and 2) the number of admissions to Zuckerberg San Francisco General will be determined by medical records. The number of hospital admissions from baseline to five month after discharge, by study arm will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Emergency room utilization at any hospital from baseline to 1 month, by study arm.</measure>
    <time_frame>Baseline and 1 month</time_frame>
    <description>Number of emergency room visits that is a composite of: 1) At baseline, participants will self-report emergency room visits to hospitals OTHER than Zuckerberg San Francisco General Hospital in the past three months, and 2) the number of emergency room visits at Zuckerberg San Francisco General will be determined by medical records.The number of emergency room visits will be reported from baseline to 1 month after discharge, by study arm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Emergency room utilization at any hospital from baseline to 5 month, by study arm.</measure>
    <time_frame>Baseline and 5 months</time_frame>
    <description>Number of ER visits that is a composite of: 1) At baseline, participants will self-report emergency room visits to hospitals OTHER than Zuckerberg San Francisco General Hospital in the past three months, and 2) the number of emergency room visits at Zuckerberg San Francisco General will be determined by medical records.The number of emergency room visits admissions will be reported from baseline to 1 month after discharge, by study arm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in overall health-related quality of life from baseline to five months, by study arm</measure>
    <time_frame>Baseline and five months</time_frame>
    <description>Health-related quality of life will be measured using the 4-item Healthy Days Core Module of the Center for Disease Control and Prevention's (CDC) Health-Related Quality of Life survey. This module asks the number of days in the past 30 days the person felt physically or mentally unwell. The summary index then estimates the number of healthy days subtracting the number of unhealthy days from 30 days. The change in healthy days from baseline to five months by study arm will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in food insecurity severity from baseline to one month by study arm</measure>
    <time_frame>Baseline and 1 month</time_frame>
    <description>The 10-item adult version of the US household food security survey module from the US Department of Agriculture (USDA) will be used to assess the change in the food security scores from baseline to one month. The score ranges from 0 to 18 in households with children, and 0 to 10 in households without children. Higher score indicates higher severity of food insecurity. The change in the food insecurity scores from baseline to one month by study arm will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in food insecurity severity from baseline to five months by study arm</measure>
    <time_frame>Baseline and 5 months</time_frame>
    <description>The 10-item adult version of the US household food security survey module from the US Department of Agriculture (USDA) will be used to assess the change in the food security scores from baseline to five months. The score ranges from 0 to 18 in households with children, and 0 to 10 in households without children. Higher score indicates higher severity of food insecurity. The change in the food insecurity scores from baseline to five months by study arm will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in consumption of food high in sodium from baseline to five months by study arm.</measure>
    <time_frame>Baseline and five moths</time_frame>
    <description>Food consumption was collected using food frequency questionnaire that assess the frequency of intake of 32 food items in the prior month. A change in the consumption (servings/day) of food high in sodium from baseline to five months will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in consumption of food high in saturated fat consumption from baseline to five months by study arm.</measure>
    <time_frame>Baseline and five months</time_frame>
    <description>Food consumption was collected using food frequency questionnaire that assess the frequency of intake of 32 food items in the prior month. A change in the consumption (servings/day) of food high in saturated fat from baseline to five months will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in medication adherence from baseline to five months, by study arm</measure>
    <time_frame>Baseline and five months</time_frame>
    <description>A Single-Item Rating Visual Analogue Scale (range 0-100) for medication adherence will estimate the percentage of medications taken in the past month and is reliable and valid, including in low-literacy populations. A higher value indicates higher adherence. The change in medication adherence (percentage points) from baseline to five months between intervention and control arms will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in depressive symptoms from baseline to five months, by study arm</measure>
    <time_frame>Baseline and five months</time_frame>
    <description>Change in depressive symptoms, using the 9 items Patient Health Questionnaire (PHQ-9), with scores ranging from 0 to 27, with higher scores indicating higher levels of depression. The change in PHQ-9 scores from baseline to one month, and from baseline to five months among by study arms will be reported.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Hospital admissions to Zuckerberg San Francisco General Hospital from baseline to nine months, by study arm</measure>
    <time_frame>Baseline and nine months</time_frame>
    <description>Number of admissions to Zuckerberg San Francisco General Hospital as determined by the medical records from baseline to one month, by study arm will be reported.</description>
  </other_outcome>
  <other_outcome>
    <measure>Emergency room utilization utilization at Zuckerberg San Francisco General Hospital from baseline to nine months by study arm</measure>
    <time_frame>Baseline and nine months</time_frame>
    <description>Number of Emergency Room visits at Zuckerberg San Francisco General Hospital as determined by the medical records will be reported by study arm from baseline to nine months.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">192</enrollment>
  <condition>Heart Failure</condition>
  <arm_group>
    <arm_group_label>Nutritional Support</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The control group will receive standard of care follow up care after their hospitalization for acute decompensated heart failure.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Nutritional Support</intervention_name>
    <description>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</description>
    <arm_group_label>Nutritional Support</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults hospitalized at Zuckerberg San Francisco General Hospital (ZSFG) with acute&#xD;
             decompensated heart failure/congestive heart failure exacerbation&#xD;
&#xD;
          -  Adults with their primary residence within San Francisco&#xD;
&#xD;
          -  Age: &gt;18 years old&#xD;
&#xD;
          -  Languages: English or Spanish&#xD;
&#xD;
          -  Housed at a location where they would be able to securely receive, store and reheat&#xD;
             food&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with severe or critical aortic stenosis.&#xD;
&#xD;
          -  Patients with six or more hospital admissions within the last twelve months&#xD;
&#xD;
          -  Patients who are being discharged to a living facility that provides meals to&#xD;
             residents.&#xD;
&#xD;
          -  Patients who anticipate moving from their current housing situation to one that does&#xD;
             not meet our inclusion criteria within six months of enrollment.&#xD;
&#xD;
          -  Patients who are part of meal provision program that provides more than 7 meals a week&#xD;
             to the patient.&#xD;
&#xD;
          -  Patients who are unable to feed themselves and do not have adequate support to help&#xD;
             them with feeding.&#xD;
&#xD;
          -  Patients with limited physical, cognitive, or behavioral abilities that would&#xD;
             interfere with their ability to follow-up with a study as determined by their ability&#xD;
             to receive the Project Open Hand services and follow up with survey interviews&#xD;
&#xD;
          -  Patients with anticipated life expectancy of less than a year.&#xD;
&#xD;
          -  Patients who lack capacity to consent to a research study.&#xD;
&#xD;
          -  Patients currently requiring dialysis or determined to be in need of dialysis in the&#xD;
             next 6 months.&#xD;
&#xD;
          -  Patients with severe allergies to eggs, soy, wheat, nuts, seeds, seed oils, pineapple,&#xD;
             raisins, or certain vegetables such as onions (allergies are considered on a&#xD;
             case-by-case basis in consultation with Project Open Hand).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rita Nguyen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>San Francisco Department of Public Health, UCSF</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sheri Weiser, MD, MPH, MA</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Francisco</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kartika Palar, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Francisco</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Binh An Phan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Francisco</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Zuckerberg San Francisco General</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>26106985</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>24309090</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>23799677</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>22210570</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>26526255</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>22903407</PMID>
  </reference>
  <reference>
    <citation>Zilak, J.P. &amp; 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</citation>
  </reference>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>November 29, 2018</study_first_submitted>
  <study_first_submitted_qc>November 29, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 30, 2018</study_first_posted>
  <last_update_submitted>March 23, 2022</last_update_submitted>
  <last_update_submitted_qc>March 23, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 5, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 10, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/25/NCT03759925/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03759925
org study id: 16-20742
nct id: NCT03759925
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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, 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.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: 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.
primary purpose: Other
masking: Single (Investigator)
masking description: The principal investigators will be masked to whether participants were in the intervention or control arm.
measure: Change in the overall Kansas City Cardiomyopathy Questionnaire (KCCQ) scores from baseline to one month by study arm
time frame: Baseline and one month
description: 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.
measure: Change in the overall Kansas City Cardiomyopathy Questionnaire (KCCQ) scores from baseline to five months by study arm
time frame: Baseline and five months
description: 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.
measure: Change in the clinical summary Kansas City Cardiomyopathy Questionnaire (KCCQ) scores from baseline to one month by study arm
time frame: Baseline and one month
description: 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.
measure: Change in the clinical summary Kansas City Cardiomyopathy Questionnaire (KCCQ) scores from baseline to five months by study arm
time frame: Baseline and five months
description: 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.
measure: Change in the physical domain Kansas City Cardiomyopathy Questionnaire (KCCQ) scores from baseline to one month by study arm
time frame: Baseline and one month
description: 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.
measure: Change in the physical domain Kansas City Cardiomyopathy Questionnaire (KCCQ) scores from baseline to five months by study arm
time frame: Baseline and five months
description: 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.
measure: Hospital admissions from baseline to 1 month, by study arm
time frame: Baseline and 1 month
description: Number of admissions to hospitals that is a composite of: 1) At baseline, participants will self-report ER visits to hospitals OTHER than Zuckerberg San Francisco General Hospital in the past three months, and 2) the number of admissions to Zuckerberg San Francisco General will be determined by medical records. The number of hospital admissions from baseline to 1 month after discharge, by study arm will be reported.
measure: Hospital admissions from baseline to 5 month, by study arm
time frame: Baseline and 5 months
description: Number of admissions to hospitals that is a composite of:1) At baseline, participants will self-report ER visits to hospitals OTHER than Zuckerberg San Francisco General Hospital in the past three months, and 2) the number of admissions to Zuckerberg San Francisco General will be determined by medical records. The number of hospital admissions from baseline to five month after discharge, by study arm will be reported.
measure: Emergency room utilization at any hospital from baseline to 1 month, by study arm.
time frame: Baseline and 1 month
description: Number of emergency room visits that is a composite of: 1) At baseline, participants will self-report emergency room visits to hospitals OTHER than Zuckerberg San Francisco General Hospital in the past three months, and 2) the number of emergency room visits at Zuckerberg San Francisco General will be determined by medical records.The number of emergency room visits will be reported from baseline to 1 month after discharge, by study arm.
measure: Emergency room utilization at any hospital from baseline to 5 month, by study arm.
time frame: Baseline and 5 months
description: Number of ER visits that is a composite of: 1) At baseline, participants will self-report emergency room visits to hospitals OTHER than Zuckerberg San Francisco General Hospital in the past three months, and 2) the number of emergency room visits at Zuckerberg San Francisco General will be determined by medical records.The number of emergency room visits admissions will be reported from baseline to 1 month after discharge, by study arm.
measure: Change in overall health-related quality of life from baseline to five months, by study arm
time frame: Baseline and five months
description: Health-related quality of life will be measured using the 4-item Healthy Days Core Module of the Center for Disease Control and Prevention's (CDC) Health-Related Quality of Life survey. This module asks the number of days in the past 30 days the person felt physically or mentally unwell. The summary index then estimates the number of healthy days subtracting the number of unhealthy days from 30 days. The change in healthy days from baseline to five months by study arm will be reported.
measure: Change in food insecurity severity from baseline to one month by study arm
time frame: Baseline and 1 month
description: The 10-item adult version of the US household food security survey module from the US Department of Agriculture (USDA) will be used to assess the change in the food security scores from baseline to one month. The score ranges from 0 to 18 in households with children, and 0 to 10 in households without children. Higher score indicates higher severity of food insecurity. The change in the food insecurity scores from baseline to one month by study arm will be reported.
measure: Change in food insecurity severity from baseline to five months by study arm
time frame: Baseline and 5 months
description: The 10-item adult version of the US household food security survey module from the US Department of Agriculture (USDA) will be used to assess the change in the food security scores from baseline to five months. The score ranges from 0 to 18 in households with children, and 0 to 10 in households without children. Higher score indicates higher severity of food insecurity. The change in the food insecurity scores from baseline to five months by study arm will be reported.
measure: Change in consumption of food high in sodium from baseline to five months by study arm.
time frame: Baseline and five moths
description: Food consumption was collected using food frequency questionnaire that assess the frequency of intake of 32 food items in the prior month. A change in the consumption (servings/day) of food high in sodium from baseline to five months will be reported.
measure: Change in consumption of food high in saturated fat consumption from baseline to five months by study arm.
time frame: Baseline and five months
description: Food consumption was collected using food frequency questionnaire that assess the frequency of intake of 32 food items in the prior month. A change in the consumption (servings/day) of food high in saturated fat from baseline to five months will be reported.
measure: Change in medication adherence from baseline to five months, by study arm
time frame: Baseline and five months
description: A Single-Item Rating Visual Analogue Scale (range 0-100) for medication adherence will estimate the percentage of medications taken in the past month and is reliable and valid, including in low-literacy populations. A higher value indicates higher adherence. The change in medication adherence (percentage points) from baseline to five months between intervention and control arms will be reported.
measure: Change in depressive symptoms from baseline to five months, by study arm
time frame: Baseline and five months
description: Change in depressive symptoms, using the 9 items Patient Health Questionnaire (PHQ-9), with scores ranging from 0 to 27, with higher scores indicating higher levels of depression. The change in PHQ-9 scores from baseline to one month, and from baseline to five months among by study arms will be reported.
measure: Hospital admissions to Zuckerberg San Francisco General Hospital from baseline to nine months, by study arm
time frame: Baseline and nine months
description: Number of admissions to Zuckerberg San Francisco General Hospital as determined by the medical records from baseline to one month, by study arm will be reported.
measure: Emergency room utilization utilization at Zuckerberg San Francisco General Hospital from baseline to nine months by study arm
time frame: Baseline and nine months
description: Number of Emergency Room visits at Zuckerberg San Francisco General Hospital as determined by the medical records will be reported by study arm from baseline to nine months.
arm group label: Nutritional Support
arm group type: Experimental
description: 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.
arm group label: Standard of Care
arm group type: No Intervention
description: The control group will receive standard of care follow up care after their hospitalization for acute decompensated heart failure.
intervention type: Other
intervention name: Nutritional Support
description: 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
arm group label: Nutritional Support
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Rita Nguyen, MD
role: Principal Investigator
affiliation: San Francisco Department of Public Health, UCSF
last name: Sheri Weiser, MD, MPH, MA
role: Principal Investigator
affiliation: University of California, San Francisco
last name: Kartika Palar, PhD
role: Principal Investigator
affiliation: University of California, San Francisco
last name: Binh An Phan, MD
role: Principal Investigator
affiliation: University of California, San Francisco
facility: 
country: United States
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PMID: 26106985
citation: 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
citation: 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
citation: 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
citation: 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
citation: 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
citation: 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
responsible party type: Sponsor
mesh term: Heart Failure
sharing ipd: No
provided document: 