<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/NCT03278678</url>
  </required_header>
  <id_info>
    <org_study_id>SanjuanS</org_study_id>
    <nct_id>NCT03278678</nct_id>
  </id_info>
  <brief_title>Nutritional Screening in Older Individuals</brief_title>
  <official_title>Nutritional Screening in Community Living Older Individuals at High Risk of Hospital Admission.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sanjuan, Silvia Forcano, M.D.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministerio de Sanidad, Servicios Sociales e Igualdad</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Sanjuan, Silvia Forcano, M.D.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hospital-based case management programs and home hospitalization services following the risk&#xD;
      stratification model of Kaiser Permanente and Kings Fund select an estimated 5% of older&#xD;
      individuals living in the community who are at high risk of hospitalization and adverse&#xD;
      outcomes. The objective of these services is to avoid deterioration and hospital admissions&#xD;
      or visits to the emergency services by regular follow-up, proactive home visits and support&#xD;
      of self-care . The prevalence of malnutrition in patients selected using this model of care&#xD;
      is unknown.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this study was to estimate the prevalence of malnutrition, using the MNA, in this&#xD;
      high-risk community living population, and to explore risk factors that could identify&#xD;
      subgroups of individuals at higher risk.&#xD;
&#xD;
      This study was performed in individuals included in a Case Management (CM) Program lead by&#xD;
      the Telemedicine Unit of a tertiary university hospital in Valencia. Patients admitted to the&#xD;
      hospital with two or more hospital admissions for medical reasons in the previous year are&#xD;
      detected by a computerized system and included in the program, an integrated care&#xD;
      intervention developed for patients with complex multimorbidity using patient-centred&#xD;
      education activities and integrated care interventions, with the support of a Hospital at&#xD;
      Home Unit (HHU). Telephone follow-ups by case manager nurses are focused on identifying&#xD;
      problems and detecting disease exacerbations. The main aim of this program is to avoid&#xD;
      hospital admissions and reduce the number of visits to emergency services&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2016</start_date>
  <completion_date type="Actual">June 30, 2016</completion_date>
  <primary_completion_date type="Actual">June 30, 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>prevalence of malnutrition</measure>
    <time_frame>2 months</time_frame>
    <description>prevalence of malnutrition by using MNA-SF</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>sexBMI</measure>
    <time_frame>2 months</time_frame>
    <description>male or female, average age, BMI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>age</measure>
    <time_frame>2 months</time_frame>
    <description>average age in years</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BMI</measure>
    <time_frame>2 months</time_frame>
    <description>body mass index in Kg / m^2</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Risk factors of malnutrition</measure>
    <time_frame>2 months</time_frame>
    <description>feeding route, use of dental prosthesis, dysphagia, consistency of foods, specific diets, oral nutritional supplements, patient group, polypharmacy, history of falls, dementia, presence of musculoskeletal, cerebrovascular, gastrointestinal or oncological disease, multimorbidity</description>
  </other_outcome>
  <enrollment type="Actual">791</enrollment>
  <condition>Malnourished</condition>
  <eligibility>
    <study_pop>
      <textblock>
        The final sample size was of 791 subjects.&#xD;
&#xD;
        The baseline characteristics were:&#xD;
&#xD;
        Mean age (years): 79.9 +/- 10.86 Female : 397 (50.2%) Mean Body Mass Index : 27.6 +/- 5.75&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients included at Case Management Program for complex chronic condition&#xD;
&#xD;
          -  Must be able to answer questions on the telephone&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with no telephone,&#xD;
&#xD;
          -  Subjects unable to determine their usual weight&#xD;
&#xD;
          -  End-of-life clinical situation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>105 Years</maximum_age>
  </eligibility>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 6, 2017</study_first_submitted>
  <study_first_submitted_qc>September 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <last_update_submitted>September 11, 2017</last_update_submitted>
  <last_update_submitted_qc>September 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sanjuan, Silvia Forcano, M.D.</investigator_affiliation>
    <investigator_full_name>Silvia Forcano Sanjuan</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Nutritional screening MNA-SF malnutrition Case Management</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Malnutrition</mesh_term>
  </condition_browse>
  <!-- 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/NCT03278678
org study id: SanjuanS
nct id: NCT03278678
lead sponsor: 
collaborator: 
has dmc: Yes
Hospital-based case management programs and home hospitalization services following the risk
      stratification model of Kaiser Permanente and Kings Fund select an estimated 5% of older
      individuals living in the community who are at high risk of hospitalization and adverse
      outcomes. The objective of these services is to avoid deterioration and hospital admissions
      or visits to the emergency services by regular follow-up, proactive home visits and support
      of self-care . The prevalence of malnutrition in patients selected using this model of care
      is unknown.
The aim of this study was to estimate the prevalence of malnutrition, using the MNA, in this
      high-risk community living population, and to explore risk factors that could identify
      subgroups of individuals at higher risk.

      This study was performed in individuals included in a Case Management (CM) Program lead by
      the Telemedicine Unit of a tertiary university hospital in Valencia. Patients admitted to the
      hospital with two or more hospital admissions for medical reasons in the previous year are
      detected by a computerized system and included in the program, an integrated care
      intervention developed for patients with complex multimorbidity using patient-centred
      education activities and integrated care interventions, with the support of a Hospital at
      Home Unit (HHU). Telephone follow-ups by case manager nurses are focused on identifying
      problems and detecting disease exacerbations. The main aim of this program is to avoid
      hospital admissions and reduce the number of visits to emergency services
observational model: Other
time perspective: Prospective
measure: prevalence of malnutrition
time frame: 2 months
description: prevalence of malnutrition by using MNA-SF
measure: sexBMI
time frame: 2 months
description: male or female, average age, BMI
measure: age
time frame: 2 months
description: average age in years
measure: BMI
time frame: 2 months
description: body mass index in Kg / m^2
measure: Risk factors of malnutrition
time frame: 2 months
description: feeding route, use of dental prosthesis, dysphagia, consistency of foods, specific diets, oral nutritional supplements, patient group, polypharmacy, history of falls, dementia, presence of musculoskeletal, cerebrovascular, gastrointestinal or oncological disease, multimorbidity
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 65 Years
maximum age: 105 Years
responsible party type: Principal Investigator
investigator affiliation: Sanjuan, Silvia Forcano, M.D.
investigator full name: Silvia Forcano Sanjuan
investigator title: Principal Investigator
mesh term: Malnutrition