<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/NCT01721239</url>
  </required_header>
  <id_info>
    <org_study_id>HIH-01863-2012-011</org_study_id>
    <nct_id>NCT01721239</nct_id>
  </id_info>
  <brief_title>Recovery and Aftercare in Post Intensive Care Therapy Patients - RAPIT Study</brief_title>
  <acronym>RAPIT</acronym>
  <official_title>Recovery and Aftercare in Post Intensive Care Therapy Patients - The RAPIT Study. The Effectiveness and Experiences of a Follow-up Program for Danish Mechanically Ventilated ICU Patients: A Pragmatic Randomized Controlled Multicentre Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hillerod Hospital, Denmark</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Herlev Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Rigshospitalet, Denmark</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Nykøbing Falster County Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Odense University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sonderborg Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Region of Southern Denmark</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Regionshospitalet Horsens</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Naestved Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hillerod Hospital, Denmark</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In 2010 alone were admitted 33,361 patients for treatment in Danish intensive care units.&#xD;
      There is evidence to former intensive care patients have a significant symptom burden that&#xD;
      affect recovery, function and activity for up to several years after admission to the&#xD;
      intensive care unit. For the individual patient involves the low quality of life, delayed&#xD;
      recovery, prolonged illness and healing process, and increased mortality. It requires that&#xD;
      health professionals should provide support so patients quicker return to their usual life.&#xD;
      Follow-up interviews with the staff after hospitalization in ICU have been shown to support&#xD;
      the patient and identify individual needs and symptoms that can lead to more realistic&#xD;
      expectations and increased well-being after admission in ICU. Follow-up in Denmark is being&#xD;
      inconsistent in both the number of hospitals that offer this service, and in the offered type&#xD;
      of service. Follow-up interviews with and without diaries suggest to improve physical and&#xD;
      mental well-being and health, with limited scientific evidence of the efficacy of these&#xD;
      interventions. We will investigate the effect of a standardized follow-up program after&#xD;
      admission to the intensive care unit, consisting of written information, patient photos taken&#xD;
      during hospitalization and three follow-up calls compared with standard care (discharge&#xD;
      without follow-up).&#xD;
&#xD;
      During a clinical study conducted in several intensive care units in Denmark examined whether&#xD;
      follow-up calls can improve patients' well-being and health, as well as the meaning of the&#xD;
      follow-up program has on the patient's everyday life in the first year after hospitalization&#xD;
      in the ICU.&#xD;
&#xD;
      The investigation contribute knowledge to the international research by revealing symptom&#xD;
      burden and efficacy of a follow-up program for up to 1 year after admission to the ICU in&#xD;
      order to be able to target rehabilitation efforts and improved the quality of life. It will&#xD;
      be innovative to use the results from a clinical study as a foundation for a database, and&#xD;
      the method can serve as a precedent for evidence-based introduction of guidelines, database&#xD;
      registration and create the groundwork for future research in intensive care. This study is&#xD;
      expected to be profitable to society by preventing frequent readmissions, reduce medication&#xD;
      costs and fewer referrals to specialists and have a positive effect on retention to the labor&#xD;
      market. This will provide overall better use of society's expenses.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2012</start_date>
  <completion_date type="Actual">October 2016</completion_date>
  <primary_completion_date type="Actual">February 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>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Quality of Life</measure>
    <time_frame>12 months</time_frame>
    <description>Changes over time in patients in the intervention and control group measured with instruments used and register data, corresponding to quality of life, on the mental component of the instrument, SF-36 Intension-to-treat analysis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Symptom Scores</measure>
    <time_frame>12 months</time_frame>
    <description>Changes in score regarding symptoms scores in control and intervention groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Baseline data</measure>
    <time_frame>At randomization</time_frame>
    <description>baseline data concerning patient's demographic and clinical data</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptom score</measure>
    <time_frame>12 months</time_frame>
    <description>Changes over time in patients in the intervention and control group measured with instruments used and register data, corresponding to symptom scores.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression</measure>
    <time_frame>12 months</time_frame>
    <description>Changes in score regarding depression in control and intervention groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sense of Coherence</measure>
    <time_frame>12 months</time_frame>
    <description>Changes over time in patients in the intervention and control group measured with instruments used and register data, corresponding to sense of coherence</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Post traumatic stress</measure>
    <time_frame>12 months</time_frame>
    <description>Changes in score regarding post traumatic stress in control and intervention groups.</description>
  </other_outcome>
  <other_outcome>
    <measure>Anxiety</measure>
    <time_frame>12months</time_frame>
    <description>Changes in score regarding anxiety in control and intervention groups.</description>
  </other_outcome>
  <other_outcome>
    <measure>Register data</measure>
    <time_frame>12 months</time_frame>
    <description>Changes in score regarding register data concerning:&#xD;
Mortality&#xD;
The number of readmissions&#xD;
Outpatient visits&#xD;
Referrals to specialists, physical and occupational therapy, including in control and intervention groups</description>
  </other_outcome>
  <other_outcome>
    <measure>Non-respondent</measure>
    <time_frame>12 months</time_frame>
    <description>A non-respondent analysis. The number of participants who dropout of the study will be separated, analyzed in control and intervention groups regarding demographic and clinical data collected during ICU stay. Investigate if there is difference in dropout in the interventiongroup versus the controlgruop.&#xD;
Intension-to-treat analysis of participants recieving the first consultation.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">340</enrollment>
  <condition>Intensive Care (ICU) Patients</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standardized Followup program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Standardized written information, patient photos and three follow-up consultations.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standardized Followup program</intervention_name>
    <description>Standardized written information, patient photos and three followup consultations.</description>
    <arm_group_label>Standardized Followup program</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  Non-invasive or invasive ventilation ≥ 48 hours (Non-invasive ventilation (NIV) from&#xD;
             current guidelines).&#xD;
&#xD;
          -  APACHE II score ≥ 12 ≤ 29&#xD;
&#xD;
          -  Unrecognized dementia diagnosis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Delirium at randomization (Positive CAM-ICU score)&#xD;
&#xD;
          -  Participation in scientific projects which include patient interviews&#xD;
&#xD;
          -  Not Speak and understand Danish&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Janet F Jensen, PhD-student</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hillerod Hospital, department of Anaesthesiology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Anaestesiology</name>
      <address>
        <city>Hillerod</city>
        <zip>3400</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <link>
    <url>http://posticu.wordpress.com</url>
    <description>Homepage for project collaborators, this requires departmental access and password</description>
  </link>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>October 31, 2012</study_first_submitted>
  <study_first_submitted_qc>November 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 4, 2012</study_first_posted>
  <last_update_submitted>April 3, 2018</last_update_submitted>
  <last_update_submitted_qc>April 3, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 4, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hillerod Hospital, Denmark</investigator_affiliation>
    <investigator_full_name>Janet Froulund Jensen</investigator_full_name>
    <investigator_title>PHD, MSc Health Science, RN.</investigator_title>
  </responsible_party>
  <keyword>ICU</keyword>
  <keyword>Follow-up consultations</keyword>
  <keyword>Quality of life</keyword>
  <keyword>Sense Of Coherence</keyword>
  <keyword>RCT multicenter study</keyword>
  <pending_results>
    <submitted>April 3, 2018</submitted>
    <returned>November 2, 2018</returned>
  </pending_results>
  <!-- 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/NCT01721239
org study id: HIH-01863-2012-011
nct id: NCT01721239
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
In 2010 alone were admitted 33,361 patients for treatment in Danish intensive care units.
      There is evidence to former intensive care patients have a significant symptom burden that
      affect recovery, function and activity for up to several years after admission to the
      intensive care unit. For the individual patient involves the low quality of life, delayed
      recovery, prolonged illness and healing process, and increased mortality. It requires that
      health professionals should provide support so patients quicker return to their usual life.
      Follow-up interviews with the staff after hospitalization in ICU have been shown to support
      the patient and identify individual needs and symptoms that can lead to more realistic
      expectations and increased well-being after admission in ICU. Follow-up in Denmark is being
      inconsistent in both the number of hospitals that offer this service, and in the offered type
      of service. Follow-up interviews with and without diaries suggest to improve physical and
      mental well-being and health, with limited scientific evidence of the efficacy of these
      interventions. We will investigate the effect of a standardized follow-up program after
      admission to the intensive care unit, consisting of written information, patient photos taken
      during hospitalization and three follow-up calls compared with standard care (discharge
      without follow-up).

      During a clinical study conducted in several intensive care units in Denmark examined whether
      follow-up calls can improve patients' well-being and health, as well as the meaning of the
      follow-up program has on the patient's everyday life in the first year after hospitalization
      in the ICU.

      The investigation contribute knowledge to the international research by revealing symptom
      burden and efficacy of a follow-up program for up to 1 year after admission to the ICU in
      order to be able to target rehabilitation efforts and improved the quality of life. It will
      be innovative to use the results from a clinical study as a foundation for a database, and
      the method can serve as a precedent for evidence-based introduction of guidelines, database
      registration and create the groundwork for future research in intensive care. This study is
      expected to be profitable to society by preventing frequent readmissions, reduce medication
      costs and fewer referrals to specialists and have a positive effect on retention to the labor
      market. This will provide overall better use of society's expenses.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
measure: Quality of Life
time frame: 12 months
description: Changes over time in patients in the intervention and control group measured with instruments used and register data, corresponding to quality of life, on the mental component of the instrument, SF-36 Intension-to-treat analysis
measure: Symptom Scores
time frame: 12 months
description: Changes in score regarding symptoms scores in control and intervention groups.
measure: Baseline data
time frame: At randomization
description: baseline data concerning patient's demographic and clinical data
measure: Symptom score
time frame: 12 months
description: Changes over time in patients in the intervention and control group measured with instruments used and register data, corresponding to symptom scores.
measure: Depression
time frame: 12 months
description: Changes in score regarding depression in control and intervention groups
measure: Sense of Coherence
time frame: 12 months
description: Changes over time in patients in the intervention and control group measured with instruments used and register data, corresponding to sense of coherence
measure: Post traumatic stress
time frame: 12 months
description: Changes in score regarding post traumatic stress in control and intervention groups.
measure: Anxiety
time frame: 12months
description: Changes in score regarding anxiety in control and intervention groups.
measure: Register data
time frame: 12 months
description: Changes in score regarding register data concerning:
Mortality
The number of readmissions
Outpatient visits
Referrals to specialists, physical and occupational therapy, including in control and intervention groups
measure: Non-respondent
time frame: 12 months
description: A non-respondent analysis. The number of participants who dropout of the study will be separated, analyzed in control and intervention groups regarding demographic and clinical data collected during ICU stay. Investigate if there is difference in dropout in the interventiongroup versus the controlgruop.
Intension-to-treat analysis of participants recieving the first consultation.
arm group label: Control group
arm group type: No Intervention
description: No intervention
arm group label: Standardized Followup program
arm group type: Experimental
description: Standardized written information, patient photos and three follow-up consultations.
intervention type: Other
intervention name: Standardized Followup program
description: Standardized written information, patient photos and three followup consultations.
arm group label: Standardized Followup program
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Janet F Jensen, PhD-student
role: Principal Investigator
affiliation: Hillerod Hospital, department of Anaesthesiology
facility: 
country: Denmark
url: http://posticu.wordpress.com
description: Homepage for project collaborators, this requires departmental access and password
responsible party type: Principal Investigator
investigator affiliation: Hillerod Hospital, Denmark
investigator full name: Janet Froulund Jensen
investigator title: PHD, MSc Health Science, RN.
submitted: April 3, 2018
returned: November 2, 2018