<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/NCT03264365</url>
  </required_header>
  <id_info>
    <org_study_id>01863 HIH-2012-011</org_study_id>
    <secondary_id>NCT-01721239</secondary_id>
    <nct_id>NCT03264365</nct_id>
  </id_info>
  <brief_title>The Effectiveness of a Post-ICU Recovery Program on Relatives</brief_title>
  <acronym>RAPIT-II</acronym>
  <official_title>The Effectiveness of a Post-ICU Recovery Program on Relatives to Patients Receiving Mechanically Ventilatory Support: Data Linked to RAPIT-I Investigation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Holbaek Sygehus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Nordsjaellands Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Herlev Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Horsens Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Nykøbing Falster County Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Naestved Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Rigshospitalet, Denmark</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Aabenraa Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sonderborg Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital of South West Jutland</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Svendborg Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Holbaek Sygehus</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Relatives of intensive care patients are at risk of developing symptoms of anxiety,&#xD;
      depression and post-traumatic stress disorder resulting in impaired health-related quality of&#xD;
      life (HRQOL). Recovery programs have been tested, but its effectiveness is sparse. The&#xD;
      hypothesis is that relatives to former intensive care patients will improve their HRQOL one&#xD;
      year after intensive care. We want to determine whether relatives to former intensive care&#xD;
      patient's benefits from a recovery programme with improved HRQOL, Sense Of Coherence (SOC)&#xD;
      and symptoms of anxiety, depression and PTSD compared to standard care one year after&#xD;
      intensive care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Relatives of intensive care patients are affected of critical illness with symptoms of&#xD;
      anxiety, depression and post-traumatic stress disorder resulting in impaired mental health.&#xD;
      Recovery programs aimed at patients after a stay at the intensive care unit (ICU) have been&#xD;
      tested and implemented, but the effectiveness is inconclusive, and on relatives sparse. The&#xD;
      aim is to determine whether relatives to former intensive care patients benefits from a&#xD;
      recovery programme with improved health-related quality of life (HRQOL), Sense Of Coherence&#xD;
      (SOC), and symptoms of anxiety, depression, and PTSD compared to standard care during the&#xD;
      first year after ICU discharge.&#xD;
&#xD;
      This was a sub-study of the &quot;Recovery and Aftercare in Post-Intensive care Therapy patients&quot;&#xD;
      (RAPIT) trial; a pragmatic, non-blinded, multicentre, parallel-group, randomized controlled&#xD;
      trial. We recruited patients and relatives concurrently during the RAPIT-trial study-period,&#xD;
      and now we are doing analysis on relatives. We wants to include adult relatives defined by&#xD;
      the patients from 10 Danish ICUs.&#xD;
&#xD;
      The study was powered to detect an effect size of a 5-point increase in the Medical Health&#xD;
      Survey Short-Form 36 (SF-36) on the mental component score (MCS) in the intervention group at&#xD;
      12 months post-ICU. Power calculation was based on an expected distribution of MCS from a&#xD;
      matched population with a mean of 36.7 (SD 11.7) from a similar study. With a statistical&#xD;
      power of 80% and significance level of 0.05, we estimated that 86 relatives were needed in&#xD;
      each group to complete follow-up.&#xD;
&#xD;
      The statistical analysis plan was based on intention-to-treat (ITT) as was per protocol (PP)&#xD;
      analysis and investigating difference between intervention and controls. Relatives were&#xD;
      considered to have received the intervention if the patient attended at least one of the&#xD;
      three consultations, which accounted for the PP analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 15, 2012</start_date>
  <completion_date type="Actual">March 6, 2018</completion_date>
  <primary_completion_date type="Actual">December 31, 2015</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>Pragmatic, non-blinded, multicenter, parallel-group randomized controlled trial</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Data analyses</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Mental Component Score</measure>
    <time_frame>12 months after ICU</time_frame>
    <description>Health-related Quality of life using Short-form-36 questionnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mental Component Score</measure>
    <time_frame>3 months after ICU</time_frame>
    <description>Health-related Quality of life using Short-form-36 questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Component Score</measure>
    <time_frame>3 months after ICU</time_frame>
    <description>Health-related Quality of life using Short-form-36 questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Component Score</measure>
    <time_frame>12 months after ICU</time_frame>
    <description>Health-related Quality of life using Short-form-36 questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety</measure>
    <time_frame>3 months after ICU</time_frame>
    <description>Anxiety measured by Hospital Anxiety and Depression Scale (HADS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety</measure>
    <time_frame>12 months after ICU</time_frame>
    <description>Anxiety measured by Hospital Anxiety and Depression Scale (HADS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression</measure>
    <time_frame>3 months after ICU</time_frame>
    <description>Depression measured by Hospital Anxiety and Depression Scale (HADS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression</measure>
    <time_frame>12 months after ICU</time_frame>
    <description>Depression measured by Hospital Anxiety and Depression Scale (HADS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-traumatic stress Disorders</measure>
    <time_frame>3 months after ICU</time_frame>
    <description>Post-traumatic stress measured by the Harvard trauma Quesionnaire, ver. IV</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-traumatic stress Disorders</measure>
    <time_frame>12 months after ICU</time_frame>
    <description>Post-traumatic stress measured by the Harvard trauma Quesionnaire, ver. IV</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sense of coherence</measure>
    <time_frame>3 months after ICU</time_frame>
    <description>Sense Of Coherence measured by the 13-item Orientation to Life questionnaire Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sense of coherence</measure>
    <time_frame>12 months after ICU</time_frame>
    <description>Sense Of Coherence measured by the 13-item Orientation to Life questionnaire Questionnaire</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">181</enrollment>
  <condition>Intensive Care Unit Syndrome</condition>
  <condition>Relatives</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Relatives participated actively in the one out of three consultation conducted by trained study nurses at two months after intensive care superimposed on standard care.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Relatives to former ICU patients, who had received standard care (SC) completed a questionnaire package at 3 and 12 months after the patient was discharged from intensive care. After enrollment were all contract handled by primary investigator.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Intervention</intervention_name>
    <description>Intervention (plus standard care)&#xD;
Patients photographs during the ICU-stay,&#xD;
Written information about life after ICU&#xD;
First consultation face-to-face in hospital setting at three months after ICU&#xD;
Visit ICU and photographs given&#xD;
Consultations as needed</description>
    <arm_group_label>Intervention</arm_group_label>
    <other_name>Standard care</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age or older&#xD;
&#xD;
          -  Defined by the patients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  If the patients dropped out or died during the study period&#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>RAPIT Steering Committee</last_name>
    <role>Study Chair</role>
    <affiliation>Region of Copenhagen Capital and Region of Zealand</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Holbæk Hospital</name>
      <address>
        <city>Holbæk</city>
        <state>Sjælland</state>
        <zip>4300</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <reference>
    <citation>Jensen JF, Egerod I, Bestle MH, Christensen DF, Elklit A, Hansen RL, Knudsen H, Grode LB, Overgaard D. A recovery program to improve quality of life, sense of coherence and psychological health in ICU survivors: a multicenter randomized controlled trial, the RAPIT study. Intensive Care Med. 2016 Nov;42(11):1733-1743. doi: 10.1007/s00134-016-4522-1. Epub 2016 Sep 30.</citation>
    <PMID>27695894</PMID>
  </reference>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>August 22, 2017</study_first_submitted>
  <study_first_submitted_qc>August 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>March 6, 2018</last_update_submitted>
  <last_update_submitted_qc>March 6, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 7, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Holbaek Sygehus</investigator_affiliation>
    <investigator_full_name>Janet Froulund Jensen</investigator_full_name>
    <investigator_title>PHD</investigator_title>
  </responsible_party>
  <keyword>Health-related quality of life</keyword>
  <keyword>Anxiety</keyword>
  <keyword>Depression</keyword>
  <keyword>Post-traumatic stress disorder</keyword>
  <keyword>Recovery programme</keyword>
  <keyword>Rehabilitation</keyword>
  <keyword>Follow-up programme</keyword>
  <keyword>Aftercare</keyword>
  <keyword>Randomized controlled Trial</keyword>
  <keyword>Multicentre</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Agreement of collaboration between sites have determinated that abstracts should be evaluated by the RAPIT-steering committee prior data are shared with other researchers.</ipd_description>
  </patient_data>
  <pending_results>
    <submitted>April 12, 2019</submitted>
    <returned>July 2, 2019</returned>
    <submitted>August 6, 2019</submitted>
    <returned>September 11, 2019</returned>
    <submitted>September 25, 2019</submitted>
    <returned>October 18, 2019</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/NCT03264365
org study id: 01863 HIH-2012-011
secondary id: NCT-01721239
nct id: NCT03264365
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Relatives of intensive care patients are at risk of developing symptoms of anxiety,
      depression and post-traumatic stress disorder resulting in impaired health-related quality of
      life (HRQOL). Recovery programs have been tested, but its effectiveness is sparse. The
      hypothesis is that relatives to former intensive care patients will improve their HRQOL one
      year after intensive care. We want to determine whether relatives to former intensive care
      patient's benefits from a recovery programme with improved HRQOL, Sense Of Coherence (SOC)
      and symptoms of anxiety, depression and PTSD compared to standard care one year after
      intensive care.
Relatives of intensive care patients are affected of critical illness with symptoms of
      anxiety, depression and post-traumatic stress disorder resulting in impaired mental health.
      Recovery programs aimed at patients after a stay at the intensive care unit (ICU) have been
      tested and implemented, but the effectiveness is inconclusive, and on relatives sparse. The
      aim is to determine whether relatives to former intensive care patients benefits from a
      recovery programme with improved health-related quality of life (HRQOL), Sense Of Coherence
      (SOC), and symptoms of anxiety, depression, and PTSD compared to standard care during the
      first year after ICU discharge.

      This was a sub-study of the "Recovery and Aftercare in Post-Intensive care Therapy patients"
      (RAPIT) trial; a pragmatic, non-blinded, multicentre, parallel-group, randomized controlled
      trial. We recruited patients and relatives concurrently during the RAPIT-trial study-period,
      and now we are doing analysis on relatives. We wants to include adult relatives defined by
      the patients from 10 Danish ICUs.

      The study was powered to detect an effect size of a 5-point increase in the Medical Health
      Survey Short-Form 36 (SF-36) on the mental component score (MCS) in the intervention group at
      12 months post-ICU. Power calculation was based on an expected distribution of MCS from a
      matched population with a mean of 36.7 (SD 11.7) from a similar study. With a statistical
      power of 80% and significance level of 0.05, we estimated that 86 relatives were needed in
      each group to complete follow-up.

      The statistical analysis plan was based on intention-to-treat (ITT) as was per protocol (PP)
      analysis and investigating difference between intervention and controls. Relatives were
      considered to have received the intervention if the patient attended at least one of the
      three consultations, which accounted for the PP analysis.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Pragmatic, non-blinded, multicenter, parallel-group randomized controlled trial
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
masking description: Data analyses
measure: Mental Component Score
time frame: 12 months after ICU
description: Health-related Quality of life using Short-form-36 questionnaire
measure: Mental Component Score
time frame: 3 months after ICU
description: Health-related Quality of life using Short-form-36 questionnaire
measure: Physical Component Score
time frame: 3 months after ICU
description: Health-related Quality of life using Short-form-36 questionnaire
measure: Physical Component Score
time frame: 12 months after ICU
description: Health-related Quality of life using Short-form-36 questionnaire
measure: Anxiety
time frame: 3 months after ICU
description: Anxiety measured by Hospital Anxiety and Depression Scale (HADS)
measure: Anxiety
time frame: 12 months after ICU
description: Anxiety measured by Hospital Anxiety and Depression Scale (HADS)
measure: Depression
time frame: 3 months after ICU
description: Depression measured by Hospital Anxiety and Depression Scale (HADS)
measure: Depression
time frame: 12 months after ICU
description: Depression measured by Hospital Anxiety and Depression Scale (HADS)
measure: Post-traumatic stress Disorders
time frame: 3 months after ICU
description: Post-traumatic stress measured by the Harvard trauma Quesionnaire, ver. IV
measure: Post-traumatic stress Disorders
time frame: 12 months after ICU
description: Post-traumatic stress measured by the Harvard trauma Quesionnaire, ver. IV
measure: Sense of coherence
time frame: 3 months after ICU
description: Sense Of Coherence measured by the 13-item Orientation to Life questionnaire Questionnaire
measure: Sense of coherence
time frame: 12 months after ICU
description: Sense Of Coherence measured by the 13-item Orientation to Life questionnaire Questionnaire
arm group label: Intervention
arm group type: Experimental
description: Relatives participated actively in the one out of three consultation conducted by trained study nurses at two months after intensive care superimposed on standard care.
arm group label: Standard care
arm group type: No Intervention
description: Relatives to former ICU patients, who had received standard care (SC) completed a questionnaire package at 3 and 12 months after the patient was discharged from intensive care. After enrollment were all contract handled by primary investigator.
intervention type: Behavioral
intervention name: Intervention
description: Intervention (plus standard care)
Patients photographs during the ICU-stay,
Written information about life after ICU
First consultation face-to-face in hospital setting at three months after ICU
Visit ICU and photographs given
Consultations as needed
arm group label: Intervention
other name: Standard care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: RAPIT Steering Committee
role: Study Chair
affiliation: Region of Copenhagen Capital and Region of Zealand
facility: 
country: Denmark
citation: Jensen JF, Egerod I, Bestle MH, Christensen DF, Elklit A, Hansen RL, Knudsen H, Grode LB, Overgaard D. A recovery program to improve quality of life, sense of coherence and psychological health in ICU survivors: a multicenter randomized controlled trial, the RAPIT study. Intensive Care Med. 2016 Nov;42(11):1733-1743. doi: 10.1007/s00134-016-4522-1. Epub 2016 Sep 30.
PMID: 27695894
responsible party type: Principal Investigator
investigator affiliation: Holbaek Sygehus
investigator full name: Janet Froulund Jensen
investigator title: PHD
sharing ipd: Undecided
ipd description: Agreement of collaboration between sites have determinated that abstracts should be evaluated by the RAPIT-steering committee prior data are shared with other researchers.
submitted: April 12, 2019
returned: July 2, 2019
submitted: August 6, 2019
returned: September 11, 2019
submitted: September 25, 2019
returned: October 18, 2019