<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/NCT03011918</url>
  </required_header>
  <id_info>
    <org_study_id>13009-H06</org_study_id>
    <nct_id>NCT03011918</nct_id>
  </id_info>
  <brief_title>Malnutrition's Role in Fall Risk</brief_title>
  <official_title>Eat Well, Fall Less</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Louis Stokes VA Medical Center</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Louis Stokes VA Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Falls and falls related injuries are considered one of the most adverse events that a patient&#xD;
      can experience. Several assessment instruments to assess and mitigate risks for falls have&#xD;
      been developed. However, these instruments have not addressed nutritional risk factors.&#xD;
&#xD;
      Weight loss and low hemoglobin levels are key components of Malnutrition. Malnutrition in the&#xD;
      hospital setting is a significant concern and may play a role as a fall risk factor.&#xD;
&#xD;
      The World Health Organization (WHO) maintains a global anemia database. WHO has identified&#xD;
      iron deficiency anemia, based on hemoglobin value alone as the most common, wide-spread&#xD;
      nutritional deficiency worldwide. Anemia is present in 30% of the worlds population including&#xD;
      industrialized nations.&#xD;
&#xD;
      The consensus statement of the Academy of Nutrition and Dietetics / American Society of&#xD;
      Parenteral and Enteral Nutrition simply defines adult under-nutrition as a continuum of&#xD;
      inadequate intake along with a multitude of other factors. Weight loss occurs at multiple&#xD;
      points along this continuum.&#xD;
&#xD;
      this multiphase retrospective descriptive analysis hypothesizes that degree of weight loss&#xD;
      and degree of Hgb decline may be fall risk factors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Eat Well, Fall Less is a multiphase retrospective descriptive analysis of single event&#xD;
      fallers and repeat fallers. Data source: Documented falls occurring between October 1, 2010&#xD;
      and October 31, 2012.&#xD;
&#xD;
      Chart Review data on weight loss and decline in Hemoglobin levels were collected 12 months, 6&#xD;
      months and 3months and 1 month prior to the first fall along as the most recent value prior&#xD;
      to the event. Additional data on vitamin D levels and C-reactive Protein values will be&#xD;
      collected at the 12 month, 6month, and 1 month prior to the first fall&#xD;
&#xD;
      Statistical Analysis using SAS version 9.1. a two tailed t-test was performed to evaluate&#xD;
      differences in HGB characteristics between single and frequent fallers. One way ANOVA&#xD;
      evaluated changes in Hgb, c-Reactive Protein, vitamin D values and weight over time are being&#xD;
      collected.&#xD;
&#xD;
      Two constellations of fallers emerged. Those with and those without dementia. The two groups&#xD;
      appeared to have different nutrition risk factors. All statistical analysis was done using&#xD;
      JMP Pro (version 10.0.0, SAS Institute, Inc, Cary, NC). Statistical significance was set at p&#xD;
      &lt; 0.05&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>April 2013</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Actual">December 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Eat Well, Fall Less</measure>
    <time_frame>4 year</time_frame>
    <description>Multiphase descriptive analysis</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">485</enrollment>
  <condition>Falling Injury</condition>
  <condition>Nutrition Disorder</condition>
  <arm_group>
    <arm_group_label>Observational Single Event Faller</arm_group_label>
    <description>one documented fall as an in-patient. It is hypothesized that the nutrition factors present prior to the first fall may be related to fall frequency. Data on exposure to nutrition supplementation will be collected for future analysis. Subpopulation alalysis of individuals with dementia will also be conducted</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Observational Multiple event faller</arm_group_label>
    <description>multiple falls documented during in-patient stay It is hypothesized that frequent fallers will demonstrate statistically greater weight decline, Hgb decline, Vitamin D deficiency and Higher C-Reactive Protein values prior to the first fall. Data on exposure to nutrition supplementation will be collected for future analysis.. Subpopulation analysis of individuals with dementia will also be conducted.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Data Collection prior to first fall for all fallers</intervention_name>
    <description>Weight history. Descriptive analysis of weight history in single event fallers compared to multiple event fallers. Information on use of any nutrition supplementation exposure will also be collected</description>
    <arm_group_label>Observational Multiple event faller</arm_group_label>
    <arm_group_label>Observational Single Event Faller</arm_group_label>
    <other_name>percent weight loss</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Hgb value</intervention_name>
    <description>Hgb decline. Descriptive analysis of single event fallers compared to multiple event fallers will be analyzed. Use of nutrition supplement exposure will be collected</description>
    <arm_group_label>Observational Multiple event faller</arm_group_label>
    <arm_group_label>Observational Single Event Faller</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Vitamin D</intervention_name>
    <description>Descriptive analysis of vitamin D status of single event fallers compared to multiple event fallers will be analyzed. Use of nutrition supplement exposure will be collected..</description>
    <arm_group_label>Observational Multiple event faller</arm_group_label>
    <arm_group_label>Observational Single Event Faller</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>C-Reactive Protein</intervention_name>
    <description>Descriptive analysis of C-RP value status of single event fallers as compared to multiple event fallers will be analyzed. Use of nutrition supplement exposure data will be collected.</description>
    <arm_group_label>Observational Multiple event faller</arm_group_label>
    <arm_group_label>Observational Single Event Faller</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Hospitalized veterans having experiencced a fall between october 31, 2010 nad October 31,&#xD;
        2012&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Veteran experienced a fall during a hospitalization between October 1, 2010 and&#xD;
             October 31, 2012&#xD;
&#xD;
          -  Veteran must have at least one documented weight a minimum of 24 months prior to&#xD;
             admission&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Adults who suffer from neurological disease or stroke&#xD;
&#xD;
          -  Adults with documented orthopedic fracture in the past 12 months&#xD;
&#xD;
          -  Documented amputation of a lower limb in the past 24 months&#xD;
&#xD;
          -  Blindness&#xD;
&#xD;
          -  History of volume overload, renal, cardiovascular or other in nature&#xD;
&#xD;
          -  current alcoholic&#xD;
&#xD;
          -  It is felt that a co-morbidity exists which makes the individuals weight history&#xD;
             inaccurate, such as a recent prosthetic device alteration.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>LSCVAMed Center</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>August 31, 2015</study_first_submitted>
  <study_first_submitted_qc>January 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 6, 2017</study_first_posted>
  <last_update_submitted>January 5, 2017</last_update_submitted>
  <last_update_submitted_qc>January 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Louis Stokes VA Medical Center</investigator_affiliation>
    <investigator_full_name>Mary M. Julius, RD,CDE</investigator_full_name>
    <investigator_title>Research Dietitian Nutritionist</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nutrition Disorders</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamin D</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Data collected in this study will be made available to future dietitians and Geriatric researchers obtaining an IRB approved protocol for ad hoc analysis.</ipd_description>
  </patient_data>
  <!-- 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/NCT03011918
org study id: 13009-H06
nct id: NCT03011918
lead sponsor: 
has dmc: No
Falls and falls related injuries are considered one of the most adverse events that a patient
      can experience. Several assessment instruments to assess and mitigate risks for falls have
      been developed. However, these instruments have not addressed nutritional risk factors.

      Weight loss and low hemoglobin levels are key components of Malnutrition. Malnutrition in the
      hospital setting is a significant concern and may play a role as a fall risk factor.

      The World Health Organization (WHO) maintains a global anemia database. WHO has identified
      iron deficiency anemia, based on hemoglobin value alone as the most common, wide-spread
      nutritional deficiency worldwide. Anemia is present in 30% of the worlds population including
      industrialized nations.

      The consensus statement of the Academy of Nutrition and Dietetics / American Society of
      Parenteral and Enteral Nutrition simply defines adult under-nutrition as a continuum of
      inadequate intake along with a multitude of other factors. Weight loss occurs at multiple
      points along this continuum.

      this multiphase retrospective descriptive analysis hypothesizes that degree of weight loss
      and degree of Hgb decline may be fall risk factors.
Eat Well, Fall Less is a multiphase retrospective descriptive analysis of single event
      fallers and repeat fallers. Data source: Documented falls occurring between October 1, 2010
      and October 31, 2012.

      Chart Review data on weight loss and decline in Hemoglobin levels were collected 12 months, 6
      months and 3months and 1 month prior to the first fall along as the most recent value prior
      to the event. Additional data on vitamin D levels and C-reactive Protein values will be
      collected at the 12 month, 6month, and 1 month prior to the first fall

      Statistical Analysis using SAS version 9.1. a two tailed t-test was performed to evaluate
      differences in HGB characteristics between single and frequent fallers. One way ANOVA
      evaluated changes in Hgb, c-Reactive Protein, vitamin D values and weight over time are being
      collected.

      Two constellations of fallers emerged. Those with and those without dementia. The two groups
      appeared to have different nutrition risk factors. All statistical analysis was done using
      JMP Pro (version 10.0.0, SAS Institute, Inc, Cary, NC). Statistical significance was set at p
      < 0.05
observational model: Case-Only
time perspective: Retrospective
measure: Eat Well, Fall Less
time frame: 4 year
description: Multiphase descriptive analysis
arm group label: Observational Single Event Faller
description: one documented fall as an in-patient. It is hypothesized that the nutrition factors present prior to the first fall may be related to fall frequency. Data on exposure to nutrition supplementation will be collected for future analysis. Subpopulation alalysis of individuals with dementia will also be conducted
arm group label: Observational Multiple event faller
description: multiple falls documented during in-patient stay It is hypothesized that frequent fallers will demonstrate statistically greater weight decline, Hgb decline, Vitamin D deficiency and Higher C-Reactive Protein values prior to the first fall. Data on exposure to nutrition supplementation will be collected for future analysis.. Subpopulation analysis of individuals with dementia will also be conducted.
intervention type: Other
intervention name: Data Collection prior to first fall for all fallers
description: Weight history. Descriptive analysis of weight history in single event fallers compared to multiple event fallers. Information on use of any nutrition supplementation exposure will also be collected
arm group label: Observational Multiple event faller
arm group label: Observational Single Event Faller
other name: percent weight loss
intervention type: Other
intervention name: Hgb value
description: Hgb decline. Descriptive analysis of single event fallers compared to multiple event fallers will be analyzed. Use of nutrition supplement exposure will be collected
arm group label: Observational Multiple event faller
arm group label: Observational Single Event Faller
intervention type: Other
intervention name: Vitamin D
description: Descriptive analysis of vitamin D status of single event fallers compared to multiple event fallers will be analyzed. Use of nutrition supplement exposure will be collected..
arm group label: Observational Multiple event faller
arm group label: Observational Single Event Faller
intervention type: Other
intervention name: C-Reactive Protein
description: Descriptive analysis of C-RP value status of single event fallers as compared to multiple event fallers will be analyzed. Use of nutrition supplement exposure data will be collected.
arm group label: Observational Multiple event faller
arm group label: Observational Single Event Faller
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Louis Stokes VA Medical Center
investigator full name: Mary M. Julius, RD,CDE
investigator title: Research Dietitian Nutritionist
mesh term: Nutrition Disorders
mesh term: Vitamin D
sharing ipd: Yes
ipd description: Data collected in this study will be made available to future dietitians and Geriatric researchers obtaining an IRB approved protocol for ad hoc analysis.