<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/NCT03814876</url>
  </required_header>
  <id_info>
    <org_study_id>2018_0004</org_study_id>
    <nct_id>NCT03814876</nct_id>
  </id_info>
  <brief_title>Family Intervention Following Traumatic Injury</brief_title>
  <acronym>FITS</acronym>
  <official_title>Effect of a Manualized Family Intervention Following Brain Injury or Spinal Cord Injury</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rigshospitalet, Denmark</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Danish Victims Fund</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Association of Eastern Founders</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Rigshospitalet, Denmark</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>
      The purpose of this study is to investigate the effectiveness of a manualized intervention&#xD;
      (FITS) to families living with brain injury or spinal cord injury. The intervention will be&#xD;
      provided by a trained neuropsychologist and consists of 8 structured sessions of 90 minutes&#xD;
      duration. The intervention group will be compared to a control group receiving treatment as&#xD;
      usual, one psycho-educational group session of a 2 hour duration.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 1, 2018</start_date>
  <completion_date type="Anticipated">April 2023</completion_date>
  <primary_completion_date type="Anticipated">April 2023</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>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Disease specific quality of life</measure>
    <time_frame>Change from day 0 to week 8, follow up at six months</time_frame>
    <description>Measured by Qolibri for patients with traumatic brain injury. The QOLIBRI consists of six novel items that assess overall satisfaction with facets of life relevant to people with TBI. Areas covered by the questionnaire include physical condition, cognition, emotions, function in daily life, personal and social life, and current situation and future prospects. Responses to each item are scored 1 ('Not at all') to 5 ('Very'), and the sum of all items was converted arithmetically to a percentage scale, with 0 representing the lowest possible HRQoL on the questionnaire and 100 the best possible HRQoL.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Generic quality of life</measure>
    <time_frame>Change from day 0 to week 8, follow up at six months</time_frame>
    <description>Short Form-36 (SF-36) completed by all participants. SF-36, a measure of self-reported HRQoL. The questionnaire comprises 36 items addressing eight dimensions of health: vitality physical functioning bodily pain general health perceptions physical role functioning emotional role functioning social role functioning mental health. The original summative scoring algorithm will be used, and raw scores will be converted into standard SF-36 scores ranging from 0-100 by calculating the product 100∗(actual sum score / highest possible score), with higher scores indicating better health. The scores will be evaluated according to Danish norms provided by Bjorner, Damsga°rd, Watt, and Bech (1997). This normative study showed high Cronbach's alpha coefficients on all the sub-scales ranging from .75-.85 (Bjorner et al., 1997).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Disease specific quality of life</measure>
    <time_frame>Change from day 0 to week 8, follow up at six months</time_frame>
    <description>QoL basic data elements for spinal cord injury for patients with spinal cord injury. The QoL Basic Data Set consists of three items on satisfaction with life as a whole, satisfaction with physical health and satisfaction with psychological health during the past 4 weeks. Each item is answered on a 0-10 numerical rating scale with markers 'complete dissatisfaction' and 'complete satisfaction'.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Caregiver burden</measure>
    <time_frame>Change from day 0 to week 8, follow up at six months</time_frame>
    <description>Caregiver burden questionnaire. The burden of the caregivers will be assessed using the 22-item scale Caregiver Burden (CB). The scale consists of five sub-scales: General Strain, Isolation, Disappointment, Emotional Involvement and Environment. A Total Burden index is given by calculating the mean of all 22 items. Each of the 22-items is scored 1-4 (Not at all, Seldom, Sometimes, Often) and the items cover aspects such as caregiver health, psychological well-being, relationship, social network, physical workload and environmental aspects.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Self-perceived burden</measure>
    <time_frame>Change from day 0 to week 8, follow up at six months</time_frame>
    <description>Burden perceived by the patient (SPB). The patients' SPB was measured with the Danish version of Self-Perceived Burden Scale (SPBS), which contains 10 items and scores range from 0-50. The 10 items were selected based on one single, general burden factor (Cousineau et al. 2003). Higher scores indicate high SPB. To estimate how severe self-perceived burden did patients feel, SPBS scores can be categorised into four stages: none to little (≤ 19), mild to moderate (20-29),moderate to severe (30-39) and severe (≥40).</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">400</enrollment>
  <condition>Acquired Brain Injury</condition>
  <condition>Spinal Cord Injuries</condition>
  <arm_group>
    <arm_group_label>SCI intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Spinal cord injury intervention group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SCI control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Spinal cord injury control</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TBI intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Traumatic brain injury intervention group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TBI control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Traumatic brain injury control group</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Group session psycho-education</intervention_name>
    <description>Active comparator - control group</description>
    <arm_group_label>SCI control</arm_group_label>
    <arm_group_label>TBI control</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>FITS</intervention_name>
    <description>Manualized family intervention</description>
    <arm_group_label>SCI intervention</arm_group_label>
    <arm_group_label>TBI intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Acquired brain injury or spinal cord injury&#xD;
&#xD;
          -  Talk and read Danish&#xD;
&#xD;
          -  Minimum 6 months to 2 years since discharge&#xD;
&#xD;
          -  Family members must be actively involved in the patient's rehabilitation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe aphasia&#xD;
&#xD;
          -  Families, where other family members require a substantial amount of care&#xD;
&#xD;
          -  Prior psychiatric or neurological disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pernille Langer Soendergaard, MSc</last_name>
    <role>Study Chair</role>
    <affiliation>Rigshospitalet, Denmark</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Anne Norup, PhD</last_name>
    <phone>+4524853396</phone>
    <email>anne.norup@regionh.dk</email>
  </overall_contact>
  <location>
    <facility>
      <name>Rigshospitalet</name>
      <address>
        <city>Hvidovre</city>
        <zip>2650</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anne Norup, PhD</last_name>
      <phone>+38622456</phone>
    </contact>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <results_reference>
    <citation>Stevens LF, Lehan T, Duran MAS, Plaza SLO, Arango-Lasprilla JC. Pilot Study of a Newly Developed Intervention for Families Facing Serious Injury. Top Spinal Cord Inj Rehabil. 2016 Winter;22(1):49-59. doi: 10.1310/sci2201-49.</citation>
    <PMID>29398893</PMID>
  </results_reference>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>January 15, 2019</study_first_submitted>
  <study_first_submitted_qc>January 23, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 24, 2019</study_first_posted>
  <last_update_submitted>January 31, 2023</last_update_submitted>
  <last_update_submitted_qc>January 31, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 2, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rigshospitalet, Denmark</investigator_affiliation>
    <investigator_full_name>Anne Norup</investigator_full_name>
    <investigator_title>Principle investigator, neuropsychologist</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Injuries</mesh_term>
    <mesh_term>Spinal Cord Injuries</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03814876
org study id: 2018_0004
nct id: NCT03814876
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to investigate the effectiveness of a manualized intervention
      (FITS) to families living with brain injury or spinal cord injury. The intervention will be
      provided by a trained neuropsychologist and consists of 8 structured sessions of 90 minutes
      duration. The intervention group will be compared to a control group receiving treatment as
      usual, one psycho-educational group session of a 2 hour duration.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Disease specific quality of life
time frame: Change from day 0 to week 8, follow up at six months
description: Measured by Qolibri for patients with traumatic brain injury. The QOLIBRI consists of six novel items that assess overall satisfaction with facets of life relevant to people with TBI. Areas covered by the questionnaire include physical condition, cognition, emotions, function in daily life, personal and social life, and current situation and future prospects. Responses to each item are scored 1 ('Not at all') to 5 ('Very'), and the sum of all items was converted arithmetically to a percentage scale, with 0 representing the lowest possible HRQoL on the questionnaire and 100 the best possible HRQoL.
measure: Generic quality of life
time frame: Change from day 0 to week 8, follow up at six months
description: Short Form-36 (SF-36) completed by all participants. SF-36, a measure of self-reported HRQoL. The questionnaire comprises 36 items addressing eight dimensions of health: vitality physical functioning bodily pain general health perceptions physical role functioning emotional role functioning social role functioning mental health. The original summative scoring algorithm will be used, and raw scores will be converted into standard SF-36 scores ranging from 0-100 by calculating the product 100∗(actual sum score / highest possible score), with higher scores indicating better health. The scores will be evaluated according to Danish norms provided by Bjorner, Damsga°rd, Watt, and Bech (1997). This normative study showed high Cronbach's alpha coefficients on all the sub-scales ranging from .75-.85 (Bjorner et al., 1997).
measure: Disease specific quality of life
time frame: Change from day 0 to week 8, follow up at six months
description: QoL basic data elements for spinal cord injury for patients with spinal cord injury. The QoL Basic Data Set consists of three items on satisfaction with life as a whole, satisfaction with physical health and satisfaction with psychological health during the past 4 weeks. Each item is answered on a 0-10 numerical rating scale with markers 'complete dissatisfaction' and 'complete satisfaction'.
measure: Caregiver burden
time frame: Change from day 0 to week 8, follow up at six months
description: Caregiver burden questionnaire. The burden of the caregivers will be assessed using the 22-item scale Caregiver Burden (CB). The scale consists of five sub-scales: General Strain, Isolation, Disappointment, Emotional Involvement and Environment. A Total Burden index is given by calculating the mean of all 22 items. Each of the 22-items is scored 1-4 (Not at all, Seldom, Sometimes, Often) and the items cover aspects such as caregiver health, psychological well-being, relationship, social network, physical workload and environmental aspects.
measure: Self-perceived burden
time frame: Change from day 0 to week 8, follow up at six months
description: Burden perceived by the patient (SPB). The patients' SPB was measured with the Danish version of Self-Perceived Burden Scale (SPBS), which contains 10 items and scores range from 0-50. The 10 items were selected based on one single, general burden factor (Cousineau et al. 2003). Higher scores indicate high SPB. To estimate how severe self-perceived burden did patients feel, SPBS scores can be categorised into four stages: none to little (≤ 19), mild to moderate (20-29),moderate to severe (30-39) and severe (≥40).
arm group label: SCI intervention
arm group type: Experimental
description: Spinal cord injury intervention group
arm group label: SCI control
arm group type: Active Comparator
description: Spinal cord injury control
arm group label: TBI intervention
arm group type: Experimental
description: Traumatic brain injury intervention group
arm group label: TBI control
arm group type: Active Comparator
description: Traumatic brain injury control group
intervention type: Behavioral
intervention name: Group session psycho-education
description: Active comparator - control group
arm group label: SCI control
arm group label: TBI control
intervention type: Behavioral
intervention name: FITS
description: Manualized family intervention
arm group label: SCI intervention
arm group label: TBI intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Pernille Langer Soendergaard, MSc
role: Study Chair
affiliation: Rigshospitalet, Denmark
last name: Anne Norup, PhD
phone: +4524853396
email: anne.norup@regionh.dk
facility: 
status: Recruiting
contact: 
country: Denmark
citation: Stevens LF, Lehan T, Duran MAS, Plaza SLO, Arango-Lasprilla JC. Pilot Study of a Newly Developed Intervention for Families Facing Serious Injury. Top Spinal Cord Inj Rehabil. 2016 Winter;22(1):49-59. doi: 10.1310/sci2201-49.
PMID: 29398893
responsible party type: Principal Investigator
investigator affiliation: Rigshospitalet, Denmark
investigator full name: Anne Norup
investigator title: Principle investigator, neuropsychologist
mesh term: Brain Injuries
mesh term: Spinal Cord Injuries
mesh term: Wounds and Injuries
sharing ipd: Undecided