<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/NCT03812458</url>
  </required_header>
  <id_info>
    <org_study_id>acute stress,anxiety</org_study_id>
    <nct_id>NCT03812458</nct_id>
  </id_info>
  <brief_title>GASA-CIR Trail (Guidance and the Symptoms of Acute Stress and Anxiety in Critically Ill Patients Relatives in Intensive Care Unit)</brief_title>
  <acronym>GASA-CIR</acronym>
  <official_title>Impact of the Guidance, Through Website and Brochure, in the Symptoms of Acute Stress and Anxiety in Relatives of Critically Ill Paciente in Intensive Care Unit: Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federal University of Rio Grande do Sul</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hospital Moinhos de Vento</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ministry of Health, Brazil</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Federal University of Rio Grande do Sul</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>
      A randomized clinical trial 1:1 among relatives of patients admitted to an intensive care&#xD;
      unit, the intervention group will be composed by family members who receive a printed&#xD;
      brochure and will be encouraged to visit a website detailed information and plain language&#xD;
      about the ICU environment and the critically ill patient characteristics. The primary outcome&#xD;
      will be the impact of orientations on symptoms of post-traumatic stress, assessed by the&#xD;
      IES-R scale. Secondary outcome measures will include symptoms of anxiety and depression at&#xD;
      the end of 7 days and after 3 months of follow-up by the HADS scales, the degree of&#xD;
      satisfaction of the relatives, through the FS-ICU scale, as well as the association of&#xD;
      resilience, through the CD-RISC scale, with the symptoms of anxiety and depression.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The hospitalization of one family member may be responsible for the generation of anxiety and&#xD;
      depression, especially if the patient environment for the intensive care unit (ICU). The&#xD;
      orientation of family members, through website and brochure, seems to have effect of reducing&#xD;
      these symptoms, however, there is a shortage of studies capable of such conduct. The focus of&#xD;
      this study will be to evaluate the impact of family guidance in reducing symptoms of&#xD;
      depression, acute stress and anxiety displayed by them, in addition to verifying the&#xD;
      association between resilience.&#xD;
&#xD;
      A randomized clinical trial 1:1 among relatives of patients admitted to an intensive care&#xD;
      unit, the randomization will be in blocks of different sizes and stratified according to the&#xD;
      educational level of the familiar. Intervention group will be composed by family members who&#xD;
      receive a printed brochure and will be encouraged to visit a website detailed information and&#xD;
      plain language about the ICU environment (treatments, care, alarms, multidisciplinary team)&#xD;
      and the critically ill patient characteristics (organic dysfunction, prognosis, palliative&#xD;
      care, organ dysfunction). The family, of the control group, will not receive the printed&#xD;
      brochure and are not encouraged to visit the website. After hospitalization of the patient in&#xD;
      the ICU, the research team will have up to 48 hrs to evaluate the eligibility criteria of the&#xD;
      next of kin of this patient. Primary outcome will be the impact of orientations on symptoms&#xD;
      of post-traumatic stress, assessed by the IES-R scale. Secondary outcome measures will&#xD;
      include symptoms of anxiety and depression at the end of 7 days and after 3 months of&#xD;
      follow-up by the HADS scale, the degree of satisfaction of the relatives, through the FS-ICU&#xD;
      scale, as well as the association of resilience, through the CD-RISC scale, with the symptoms&#xD;
      of anxiety and depression The study will occur with families of patients admitted to the ICUs&#xD;
      of Hospital Moinhos de Vento and Hospital Ernesto Dornelles. We will collect characteristics&#xD;
      related to demographic, social, educational features, levels of resilience, religiosity and&#xD;
      prior history of mood disorder, anxiety disorder or post-traumatic stress disorder, length of&#xD;
      ICU stay, SAPS III, and ICU and hospital outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 10, 2019</start_date>
  <completion_date type="Anticipated">December 10, 2020</completion_date>
  <primary_completion_date type="Anticipated">March 2, 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>Parallel multicentric randomized clinical trial</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Acute stress in critically ill relatives.</measure>
    <time_frame>After 7 days from enrollment in ICU.</time_frame>
    <description>Using the Impact of Events Scale-Revised. The scale contains 22 questions. It evaluates the subjective distress caused by traumatic events. Items are rated on a 5-point scale, ranging from 0 (nothing) to 4 (extremely). The total score ranges from 0 to 88. A score greater than 33 identifies individuals with symptoms of acute stress disorder.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Satisfaction of the relatives of patients admitted to the ICU: FS-ICU scale</measure>
    <time_frame>After 7 days from enrollment in ICU.</time_frame>
    <description>Using the FS-ICU scale. The Family Satisfaction in the Intensive Care Unit (FS-ICU) questionnaire measures family satisfaction with care in the intensive care unit. The score ranges 0-100, with higher scores indicating greater satisfaction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptoms of post-traumatic stress.</measure>
    <time_frame>3 months from enrollment in ICU.</time_frame>
    <description>Assessed by the Impact of Events Scale-Revised (IES-R). The scale contains 22 questions. It evaluates the subjective distress caused by traumatic events. Items are rated on a 5-point scale, ranging from 0 (nothing) to 4 (extremely). The total score ranges from 0 to 88. A score greater than 33 identifies individuals with symptoms of acute stress disorder.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptoms of anxiety and depression</measure>
    <time_frame>3 months from enrollment in ICU.</time_frame>
    <description>Using the HADS scale. The questionnaire is composed of 14 questions. The total score ranges from 0 to 42. Score greater than 8 in subgroup, or a total score greater than 16, identify patients with anxiety and depression symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptoms of anxiety and depression</measure>
    <time_frame>After 7 days from enrollment in ICU.</time_frame>
    <description>Using the HADS scale. The questionnaire is composed of 14 questions. The total score ranges from 0 to 42. Score greater than 8 in subgroup, or a total score greater than 16, identify patients with anxiety and depression symptoms.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">190</enrollment>
  <condition>Acute Stress Disorder</condition>
  <condition>Anxiety</condition>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>Guidance</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention group will consist of the relatives who will receive a printed brochure and are encouraged to visit a website with detailed information and with simple language regarding the ICU environment (treatments, care, alarms, multidisciplinary team) and the characteristics of critically ill patients (organ dysfunction, prognosis, palliative care, organ dysfunction).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The families who will not receive the brochure and are not encouraged to visit the website.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>website and brochure</intervention_name>
    <description>website and brochure</description>
    <arm_group_label>Guidance</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  For patient, with more than 18 years old, who ICU admission exceeding 48 hours;&#xD;
&#xD;
          -  For Patient's Family Members: familiar close to a patient hospitalized in the ICU&#xD;
             (spouse, father, mother, son, daughter, grandmother, brother, sister, uncle, aunt,&#xD;
             cousin);&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - For Patient's Family Members: communication difficulty (illiteracy, not speaking&#xD;
        Portuguese, deafness or mutism). Some other family member of the patient has already been&#xD;
        included in the study. Refusal to sign the term of free and clarified consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Vitória Homem Machado</last_name>
    <phone>55 51 991022093</phone>
    <email>vitoriahomemmachado@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Hospital Moinhos de Vento - ICU</last_name>
    <phone>55 51 33143434</phone>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hospital Moinhos de Vento</name>
      <address>
        <city>Porto Alegre</city>
        <state>Rio Grande Do Sul</state>
        <zip>90035902</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vitoria Machado</last_name>
      <email>vitoriahomemmachado@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>November 5, 2018</study_first_submitted>
  <study_first_submitted_qc>January 22, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>January 9, 2020</last_update_submitted>
  <last_update_submitted_qc>January 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Federal University of Rio Grande do Sul</investigator_affiliation>
    <investigator_full_name>Vitória Homem Machado</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>resilience</keyword>
  <keyword>anxiety</keyword>
  <keyword>acute stress</keyword>
  <keyword>relatives</keyword>
  <keyword>critical ill patients</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anxiety Disorders</mesh_term>
    <mesh_term>Stress Disorders, Traumatic, Acute</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/NCT03812458
org study id: acute stress,anxiety
nct id: NCT03812458
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A randomized clinical trial 1:1 among relatives of patients admitted to an intensive care
      unit, the intervention group will be composed by family members who receive a printed
      brochure and will be encouraged to visit a website detailed information and plain language
      about the ICU environment and the critically ill patient characteristics. The primary outcome
      will be the impact of orientations on symptoms of post-traumatic stress, assessed by the
      IES-R scale. Secondary outcome measures will include symptoms of anxiety and depression at
      the end of 7 days and after 3 months of follow-up by the HADS scales, the degree of
      satisfaction of the relatives, through the FS-ICU scale, as well as the association of
      resilience, through the CD-RISC scale, with the symptoms of anxiety and depression.
The hospitalization of one family member may be responsible for the generation of anxiety and
      depression, especially if the patient environment for the intensive care unit (ICU). The
      orientation of family members, through website and brochure, seems to have effect of reducing
      these symptoms, however, there is a shortage of studies capable of such conduct. The focus of
      this study will be to evaluate the impact of family guidance in reducing symptoms of
      depression, acute stress and anxiety displayed by them, in addition to verifying the
      association between resilience.

      A randomized clinical trial 1:1 among relatives of patients admitted to an intensive care
      unit, the randomization will be in blocks of different sizes and stratified according to the
      educational level of the familiar. Intervention group will be composed by family members who
      receive a printed brochure and will be encouraged to visit a website detailed information and
      plain language about the ICU environment (treatments, care, alarms, multidisciplinary team)
      and the critically ill patient characteristics (organic dysfunction, prognosis, palliative
      care, organ dysfunction). The family, of the control group, will not receive the printed
      brochure and are not encouraged to visit the website. After hospitalization of the patient in
      the ICU, the research team will have up to 48 hrs to evaluate the eligibility criteria of the
      next of kin of this patient. Primary outcome will be the impact of orientations on symptoms
      of post-traumatic stress, assessed by the IES-R scale. Secondary outcome measures will
      include symptoms of anxiety and depression at the end of 7 days and after 3 months of
      follow-up by the HADS scale, the degree of satisfaction of the relatives, through the FS-ICU
      scale, as well as the association of resilience, through the CD-RISC scale, with the symptoms
      of anxiety and depression The study will occur with families of patients admitted to the ICUs
      of Hospital Moinhos de Vento and Hospital Ernesto Dornelles. We will collect characteristics
      related to demographic, social, educational features, levels of resilience, religiosity and
      prior history of mood disorder, anxiety disorder or post-traumatic stress disorder, length of
      ICU stay, SAPS III, and ICU and hospital outcomes.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Parallel multicentric randomized clinical trial
primary purpose: Prevention
masking: None (Open Label)
measure: Acute stress in critically ill relatives.
time frame: After 7 days from enrollment in ICU.
description: Using the Impact of Events Scale-Revised. The scale contains 22 questions. It evaluates the subjective distress caused by traumatic events. Items are rated on a 5-point scale, ranging from 0 (nothing) to 4 (extremely). The total score ranges from 0 to 88. A score greater than 33 identifies individuals with symptoms of acute stress disorder.
measure: Satisfaction of the relatives of patients admitted to the ICU: FS-ICU scale
time frame: After 7 days from enrollment in ICU.
description: Using the FS-ICU scale. The Family Satisfaction in the Intensive Care Unit (FS-ICU) questionnaire measures family satisfaction with care in the intensive care unit. The score ranges 0-100, with higher scores indicating greater satisfaction.
measure: Symptoms of post-traumatic stress.
time frame: 3 months from enrollment in ICU.
description: Assessed by the Impact of Events Scale-Revised (IES-R). The scale contains 22 questions. It evaluates the subjective distress caused by traumatic events. Items are rated on a 5-point scale, ranging from 0 (nothing) to 4 (extremely). The total score ranges from 0 to 88. A score greater than 33 identifies individuals with symptoms of acute stress disorder.
measure: Symptoms of anxiety and depression
time frame: 3 months from enrollment in ICU.
description: Using the HADS scale. The questionnaire is composed of 14 questions. The total score ranges from 0 to 42. Score greater than 8 in subgroup, or a total score greater than 16, identify patients with anxiety and depression symptoms.
measure: Symptoms of anxiety and depression
time frame: After 7 days from enrollment in ICU.
description: Using the HADS scale. The questionnaire is composed of 14 questions. The total score ranges from 0 to 42. Score greater than 8 in subgroup, or a total score greater than 16, identify patients with anxiety and depression symptoms.
arm group label: Guidance
arm group type: Experimental
description: The intervention group will consist of the relatives who will receive a printed brochure and are encouraged to visit a website with detailed information and with simple language regarding the ICU environment (treatments, care, alarms, multidisciplinary team) and the characteristics of critically ill patients (organ dysfunction, prognosis, palliative care, organ dysfunction).
arm group label: Control
arm group type: No Intervention
description: The families who will not receive the brochure and are not encouraged to visit the website.
intervention type: Behavioral
intervention name: website and brochure
description: website and brochure
arm group label: Guidance
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Vitória Homem Machado
phone: 55 51 991022093
email: vitoriahomemmachado@gmail.com
last name: Hospital Moinhos de Vento - ICU
phone: 55 51 33143434
facility: 
status: Recruiting
contact: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Federal University of Rio Grande do Sul
investigator full name: Vitória Homem Machado
investigator title: Principal Investigator
mesh term: Anxiety Disorders
mesh term: Stress Disorders, Traumatic, Acute
sharing ipd: No