<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/NCT01726244</url>
  </required_header>
  <id_info>
    <org_study_id>AC-01</org_study_id>
    <nct_id>NCT01726244</nct_id>
  </id_info>
  <brief_title>Self-care Program in the Prevention of Admissions of Patients</brief_title>
  <acronym>AUTOCUID</acronym>
  <official_title>Effectiveness of an Self-care Program in the Prevention of Admissions of Patients With Hospitalizations Potentially Avoidable: Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Basque Health Service</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Basque Health Service</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      One of the most cost effective intervention is to avoid unnecessary hospitalizations in the&#xD;
      national health system. These unnecessary admissions are increasing for several years,&#xD;
      reaching rates of over 30% in patients with chronic obstructive pulmonary disease (COPD) or&#xD;
      heart failure at two months of hospital discharge. There is scientific evidence suggesting&#xD;
      that a multidisciplinary intervention consisting in controling disease and stress associated&#xD;
      with disease, and modifying eating habits could reduce the number of hospitalizations due to&#xD;
      disease decompensation.&#xD;
&#xD;
      The main objective of the study is to assess the rate of readmissions at year of&#xD;
      multidisciplinary intervention in patients with COPD and / or heart failure.&#xD;
&#xD;
      We will select 144 patients who will be randomized to two groups (control and intervention&#xD;
      group) and they will be followed for 12 months through 4 visits (1 month, 3 months, 6 months&#xD;
      and 12 months of hospital discharge).&#xD;
&#xD;
      Patients assigned to the intervention group will be receive three educational sessions (one&#xD;
      of them will be imparted by nursing, another by the nutritionist and the last one by the&#xD;
      psychologist). In addition, patients with a BMI &lt;20 and / or&gt; 30 will receive a closer&#xD;
      monitoring by the nutritionist).&#xD;
&#xD;
      Patients assigned to the control group will receive usual care in clinical practice.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>December 2012</start_date>
  <completion_date type="Anticipated">March 2014</completion_date>
  <primary_completion_date type="Anticipated">March 2014</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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Readmission rate</measure>
    <time_frame>12 months</time_frame>
    <description>in the twelve months following the intervention, according to the electronic record of the hospital</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of admissions to emergency service or number of visits to general practitioner's office or number of visits to emergency service</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>time until the first admission to the hospital</measure>
    <time_frame>it wil be measured at 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>time until first visit to general practitioner's office</measure>
    <time_frame>it will be measured at 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>time until the first visit to emergency service</measure>
    <time_frame>it will be measured at 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health related quality of life through several questionnaires</measure>
    <time_frame>At month, 3, 6 and 12 months after discharge</time_frame>
    <description>COPD Assessment Test (CAT), self efficacy scale in COPD patients, SORT Form-36, Patient Health Questionnaire-9, Minnesota Living with Heart Failure Questionnaire (MLHFQ), Physical Activity Questionnaire (IPAQ), Barthel Index, European heart failure self-care behaviour scale.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>HbA1c</measure>
    <time_frame>at month, 3, 6 and 12 months</time_frame>
    <description>glycated hemoglobin</description>
  </other_outcome>
  <other_outcome>
    <measure>Type B natriuretic peptide (BNP), blood pressure</measure>
    <time_frame>At month, 3, 6 and 12 months of discharge</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>APACHE III INDEX, Functional Category of New York Heart Association (NYHA)</measure>
    <time_frame>1 day</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">144</enrollment>
  <condition>Pulmonary Disease, Chronic Obstructive</condition>
  <condition>Heart Failure</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Habitual Clinical Practice</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Multidisciplinary intervention consisting in controlling disease and stress associated to it, and modifying eating habits. A Nurse, nutritionist and a psychologist will be the responsible of these educational sessions. it will be three educational sessions. Patients with a BMI lower than 20 or bigger than 30 will be receive a closer follow up by nutritionist. In addition, patients with a score of 9 or more in the Patients Health Questionnaire-9 questionnaire will be also a closer follow up with the psychologist.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Multidisciplinary Intervention</intervention_name>
    <description>Health education sessions consisting in controlling disease and stress asociated to it, and modifying eating habits</description>
    <arm_group_label>Intervention Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  COPD&#xD;
&#xD;
          -  Heart failure: heart failure in clinically stable with ≥ II degree of NYHA . 1 or more&#xD;
             emergency admissions for the same diagnosis in the prior year&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Mental states that make difficult the self-care: Class 295, 296, 297, 298, 300, 301,&#xD;
             304 and 316 (schizophrenic disorders, episodic mood, delusional other nonorganic&#xD;
             psychosis, anxiety, dissociative and somatoform, personality, alcohol and drug&#xD;
             dependencies)&#xD;
&#xD;
          -  Congenital respiratory diseases or presence of other obstructive pulmonary diseases&#xD;
&#xD;
          -  Patients participating in other research studies.&#xD;
&#xD;
          -  Other diseases that can affect patients' medium-term survival&#xD;
&#xD;
          -  Moderate to severe cognitive impairment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Araba Universitary Hospital (Txagorritxu)</name>
      <address>
        <city>Vitoria-Gasteiz</city>
        <state>Alava</state>
        <zip>01009</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Naiara Parraza, PhD</last_name>
      <phone>945007413</phone>
      <email>naiara.parrazadiez@osakidetza.net</email>
    </contact>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 9, 2012</study_first_submitted>
  <study_first_submitted_qc>November 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 14, 2012</study_first_posted>
  <last_update_submitted>March 4, 2013</last_update_submitted>
  <last_update_submitted_qc>March 4, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 5, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Basque Health Service</investigator_affiliation>
    <investigator_full_name>Naiara Parraza Diez</investigator_full_name>
    <investigator_title>main researcher</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pulmonary Disease, Chronic Obstructive</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/NCT01726244
org study id: AC-01
nct id: NCT01726244
lead sponsor: 
has dmc: No
One of the most cost effective intervention is to avoid unnecessary hospitalizations in the
      national health system. These unnecessary admissions are increasing for several years,
      reaching rates of over 30% in patients with chronic obstructive pulmonary disease (COPD) or
      heart failure at two months of hospital discharge. There is scientific evidence suggesting
      that a multidisciplinary intervention consisting in controling disease and stress associated
      with disease, and modifying eating habits could reduce the number of hospitalizations due to
      disease decompensation.

      The main objective of the study is to assess the rate of readmissions at year of
      multidisciplinary intervention in patients with COPD and / or heart failure.

      We will select 144 patients who will be randomized to two groups (control and intervention
      group) and they will be followed for 12 months through 4 visits (1 month, 3 months, 6 months
      and 12 months of hospital discharge).

      Patients assigned to the intervention group will be receive three educational sessions (one
      of them will be imparted by nursing, another by the nutritionist and the last one by the
      psychologist). In addition, patients with a BMI <20 and / or> 30 will receive a closer
      monitoring by the nutritionist).

      Patients assigned to the control group will receive usual care in clinical practice.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Readmission rate
time frame: 12 months
description: in the twelve months following the intervention, according to the electronic record of the hospital
measure: Number of admissions to emergency service or number of visits to general practitioner's office or number of visits to emergency service
time frame: 12 months
measure: time until the first admission to the hospital
time frame: it wil be measured at 12 months
measure: time until first visit to general practitioner's office
time frame: it will be measured at 12 months
measure: time until the first visit to emergency service
time frame: it will be measured at 12 months
measure: Health related quality of life through several questionnaires
time frame: At month, 3, 6 and 12 months after discharge
description: COPD Assessment Test (CAT), self efficacy scale in COPD patients, SORT Form-36, Patient Health Questionnaire-9, Minnesota Living with Heart Failure Questionnaire (MLHFQ), Physical Activity Questionnaire (IPAQ), Barthel Index, European heart failure self-care behaviour scale.
measure: HbA1c
time frame: at month, 3, 6 and 12 months
description: glycated hemoglobin
measure: Type B natriuretic peptide (BNP), blood pressure
time frame: At month, 3, 6 and 12 months of discharge
measure: APACHE III INDEX, Functional Category of New York Heart Association (NYHA)
time frame: 1 day
arm group label: Control group
arm group type: No Intervention
description: Habitual Clinical Practice
arm group label: Intervention Group
arm group type: Experimental
description: Multidisciplinary intervention consisting in controlling disease and stress associated to it, and modifying eating habits. A Nurse, nutritionist and a psychologist will be the responsible of these educational sessions. it will be three educational sessions. Patients with a BMI lower than 20 or bigger than 30 will be receive a closer follow up by nutritionist. In addition, patients with a score of 9 or more in the Patients Health Questionnaire-9 questionnaire will be also a closer follow up with the psychologist.
intervention type: Behavioral
intervention name: Multidisciplinary Intervention
description: Health education sessions consisting in controlling disease and stress asociated to it, and modifying eating habits
arm group label: Intervention Group
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
status: Recruiting
contact: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Basque Health Service
investigator full name: Naiara Parraza Diez
investigator title: main researcher
mesh term: Pulmonary Disease, Chronic Obstructive