<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/NCT03265691</url>
  </required_header>
  <id_info>
    <org_study_id>V01_Enf</org_study_id>
    <nct_id>NCT03265691</nct_id>
  </id_info>
  <brief_title>Hyponatremia in the Prevention of Hospitalized Patients Falls</brief_title>
  <acronym>PRECAHI</acronym>
  <official_title>Effectiveness of Early Intervention in the Diagnosis and Treatment of Hyponatremia in the Prevention of Hospitalized Patients Falls</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mª del Carmen Lobo Rodríguez</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fundación Mutua Madrileña</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hospital General Universitario Gregorio Marañon</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cross ecological quasi-experimental study to assess effectiveness of early intervention in&#xD;
      the diagnosis and treatment of hyponatremia in the prevention of hospitalized patients´&#xD;
      falls.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Effectiveness of early intervention in the diagnosis and treatment of hyponatremia in the&#xD;
      prevention of hospitalized patients´ falls.&#xD;
&#xD;
      Aims:&#xD;
&#xD;
        1. To assess the effectiveness of corrective activity of hyponatremia in falls reducing&#xD;
           incidence.&#xD;
&#xD;
        2. To assess the cost-effectiveness ratio of the two proposed strategies: conventional&#xD;
           treatment versus early intervention.&#xD;
&#xD;
      Cross ecological quasi-experimental study. The project will take place in Gregorio Marañón&#xD;
      Hospital (Madrid, Spain) in the following inpatient adult Units: Neurology, Rehabilitation 1,&#xD;
      Geriatrics, Internal Medicine (Group A), Cardiology, Rehabilitation 2, Gastroenterology,&#xD;
      Neurosurgery and Oncology (Group B).&#xD;
&#xD;
      The estimated sample size for a confidence level of 95% (α = 0.05) and power of 90% (β =&#xD;
      0.010), taking into account a decrease in the incidence of falls of 20% restocking losses, is&#xD;
      124 patients per group (ie, the 124 patients receiving regular performance ** and 124&#xD;
      patients receiving the experimental intervention *, if necessary, by participant Unit).&#xD;
&#xD;
      Data collection: In each of the study participants Units both interventions will be held.&#xD;
      First the participants Units have been randomized in two groups (Group A: Neurology,&#xD;
      Rehabilitation 1, Geriatrics, Internal Medicine; Group B: Cardiology, Rehabilitation 2,&#xD;
      Gastroenterology, Neurosurgery and Oncology). All patients hospitalized in these Units will&#xD;
      be potentially included. First of all, collaborators will give them an informed consent to&#xD;
      ask for their participation.&#xD;
&#xD;
      The interventions are:&#xD;
&#xD;
        -  Experimental intervention: early diagnosis, treatment of hyponatremia until resolution&#xD;
           and valuation according to the Dynamic Gait Index test. Duration: 6 months&#xD;
&#xD;
        -  Habitual action: the usual pattern of work will be performed in all patients who enter.&#xD;
           Duration: 6 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2014</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">December 2016</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>Crossover Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To evaluate the effectiveness of treatment of hyponatremia in reducing the incidence of falls.</measure>
    <time_frame>1 year</time_frame>
    <description>The effectiveness will be measured in terms of less incidence of falls</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To evaluate the cost-effectiveness of the 2 strategies proposed: conventional treatment vs early intervention.</measure>
    <time_frame>1 year</time_frame>
    <description>The cost-effectiveness will be indirectly measured using Average cost per inpatient day</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">124</enrollment>
  <condition>Hyponatremia</condition>
  <condition>Accidental Falls</condition>
  <arm_group>
    <arm_group_label>Early hyponatremia diagnosis and treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The early diagnosis of hiponatremia is not a stándar procedure. In the experimental arm, hyponatremia will be diagnosed and treated early.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No intervention</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Usual pattern of work will be performed in all patients who enter in Hospital. Duration: 6 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Early detection and treatment of hyponatremia</intervention_name>
    <description>In the experimental group, hyponatremia will be diagnosed and treated early. Therefore, the researchers will review the patients' sodium levels at admission and throughout their stay.</description>
    <arm_group_label>Early hyponatremia diagnosis and treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No Intervention (SOC)</intervention_name>
    <description>Usual pattern of work will be performed in all patients who enter in Hospital.</description>
    <arm_group_label>Early hyponatremia diagnosis and treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt;65 years&#xD;
&#xD;
          -  Admitted to a participating study unit&#xD;
&#xD;
          -  Wish to participate in the study and signature of informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Transfer of the patient to a unit not included in the study&#xD;
&#xD;
          -  Deterioration of the patient's condition to severe or extremely painful&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Carmen Lobo-Rodriguez, pHd</last_name>
    <role>Principal Investigator</role>
    <affiliation>carmen.lobo@salud.madrid.org</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital General Universitario Gregorio Marañón</name>
      <address>
        <city>Madrid</city>
        <zip>28007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>May 10, 2016</study_first_submitted>
  <study_first_submitted_qc>August 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>August 28, 2017</last_update_submitted>
  <last_update_submitted_qc>August 28, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 29, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Hospital General Universitario Gregorio Marañon</investigator_affiliation>
    <investigator_full_name>Mª del Carmen Lobo Rodríguez</investigator_full_name>
    <investigator_title>Msc Nurse Research</investigator_title>
  </responsible_party>
  <keyword>Accidental Falls</keyword>
  <keyword>Hyponatremia</keyword>
  <keyword>Elderly</keyword>
  <keyword>Risk factors</keyword>
  <keyword>Nurse</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyponatremia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03265691
org study id: V01_Enf
nct id: NCT03265691
lead sponsor: 
collaborator: 
has dmc: No
Cross ecological quasi-experimental study to assess effectiveness of early intervention in
      the diagnosis and treatment of hyponatremia in the prevention of hospitalized patients´
      falls.
Effectiveness of early intervention in the diagnosis and treatment of hyponatremia in the
      prevention of hospitalized patients´ falls.

      Aims:

        1. To assess the effectiveness of corrective activity of hyponatremia in falls reducing
           incidence.

        2. To assess the cost-effectiveness ratio of the two proposed strategies: conventional
           treatment versus early intervention.

      Cross ecological quasi-experimental study. The project will take place in Gregorio Marañón
      Hospital (Madrid, Spain) in the following inpatient adult Units: Neurology, Rehabilitation 1,
      Geriatrics, Internal Medicine (Group A), Cardiology, Rehabilitation 2, Gastroenterology,
      Neurosurgery and Oncology (Group B).

      The estimated sample size for a confidence level of 95% (α = 0.05) and power of 90% (β =
      0.010), taking into account a decrease in the incidence of falls of 20% restocking losses, is
      124 patients per group (ie, the 124 patients receiving regular performance ** and 124
      patients receiving the experimental intervention *, if necessary, by participant Unit).

      Data collection: In each of the study participants Units both interventions will be held.
      First the participants Units have been randomized in two groups (Group A: Neurology,
      Rehabilitation 1, Geriatrics, Internal Medicine; Group B: Cardiology, Rehabilitation 2,
      Gastroenterology, Neurosurgery and Oncology). All patients hospitalized in these Units will
      be potentially included. First of all, collaborators will give them an informed consent to
      ask for their participation.

      The interventions are:

        -  Experimental intervention: early diagnosis, treatment of hyponatremia until resolution
           and valuation according to the Dynamic Gait Index test. Duration: 6 months

        -  Habitual action: the usual pattern of work will be performed in all patients who enter.
           Duration: 6 months.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: To evaluate the effectiveness of treatment of hyponatremia in reducing the incidence of falls.
time frame: 1 year
description: The effectiveness will be measured in terms of less incidence of falls
measure: To evaluate the cost-effectiveness of the 2 strategies proposed: conventional treatment vs early intervention.
time frame: 1 year
description: The cost-effectiveness will be indirectly measured using Average cost per inpatient day
arm group label: Early hyponatremia diagnosis and treatment
arm group type: Experimental
description: The early diagnosis of hiponatremia is not a stándar procedure. In the experimental arm, hyponatremia will be diagnosed and treated early.
arm group label: No intervention
arm group type: No Intervention
description: Usual pattern of work will be performed in all patients who enter in Hospital. Duration: 6 months.
intervention type: Other
intervention name: Early detection and treatment of hyponatremia
description: In the experimental group, hyponatremia will be diagnosed and treated early. Therefore, the researchers will review the patients' sodium levels at admission and throughout their stay.
arm group label: Early hyponatremia diagnosis and treatment
intervention type: Other
intervention name: No Intervention (SOC)
description: Usual pattern of work will be performed in all patients who enter in Hospital.
arm group label: Early hyponatremia diagnosis and treatment
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Carmen Lobo-Rodriguez, pHd
role: Principal Investigator
affiliation: carmen.lobo@salud.madrid.org
facility: 
country: Spain
responsible party type: Sponsor-Investigator
investigator affiliation: Hospital General Universitario Gregorio Marañon
investigator full name: Mª del Carmen Lobo Rodríguez
investigator title: Msc Nurse Research
mesh term: Hyponatremia
sharing ipd: No