<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/NCT01715506</url>
  </required_header>
  <id_info>
    <org_study_id>2012/304</org_study_id>
    <nct_id>NCT01715506</nct_id>
  </id_info>
  <brief_title>Continuing Education in Nursing Home Dementia Care</brief_title>
  <acronym>MEDCED</acronym>
  <official_title>Modeling and Evaluating Evidence Based Continuing Education in Nursing Home Dementia Care</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bergen University College</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Research Council of Norway</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Bergen University College</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a single-blinded controlled cluster-randomized intervention trial recruiting staff&#xD;
      from 24 NHs in three counties in the region of Western Norway, randomly selected from the&#xD;
      total NH population in the region. A cluster is defined as a working ward of a larger NH,&#xD;
      without shared facilities or staff. The 24 NHs are randomized into two groups, for&#xD;
      intervention (12) and control (12). One department in each is selected for intervention and&#xD;
      data collection will take place also in one department in each of the NHs in the control&#xD;
      group. Hence the analyzed units (clusters) are NH departments. The educational intervention&#xD;
      (EI), Relation Related Care (RRC), consists of a two-day seminar and one hour monthly&#xD;
      guidance for six months. A seven-month educational intervention will be performed, and due to&#xD;
      ethical issues the control group will receive the same intervention after the second&#xD;
      follow-up. Effects will be measured on resident and care staff level at baseline before&#xD;
      randomization, after the intervention (7 months) and at follow-up (7 months later) of the&#xD;
      intervention group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Purpose:&#xD;
&#xD;
      Dementia is a major challenge for our society. In Norway, around 40 % of persons suffering&#xD;
      from dementia live in nursing homes (NH), and the majority experiences severe functional&#xD;
      impairments and complex needs including associated behavioral changes. International studies&#xD;
      indicate that NH residents with cognitive impairment and high dependency are most likely to&#xD;
      be restrained physically. There is evidence of various adverse effects such as injuries,&#xD;
      reduced psychological well-being or decreased mobility related to the use of physical&#xD;
      restraint. Moreover, in addition to ethical and professional arguments, there is evidence&#xD;
      supporting that user-involvement and shared decision-making have positive effects for both&#xD;
      residents and staff. The aim of the present study (MEDCED) is to carry out an educational&#xD;
      intervention in care staff to test its potential effect on use of restraint in NH residents&#xD;
      with dementia and increase job-satisfaction in care staff.&#xD;
&#xD;
      Description:&#xD;
&#xD;
      This is a single-blinded controlled cluster-randomized intervention trial recruiting staff&#xD;
      from 24 NHs in three counties in the region of Western Norway, randomly selected from the&#xD;
      total NH population in the region. A cluster is defined as a working ward of a larger NH,&#xD;
      without shared facilities or staff. The 24 NHs are randomized into two groups, for&#xD;
      intervention (12) and control (12). One department in each is selected for intervention and&#xD;
      data collection will take place also in one department in each of the NHs in the control&#xD;
      group. Hence the analyzed units (clusters) are NH departments. The educational intervention&#xD;
      (EI), Relation Related Care (RRC), consists of a two-day seminar and one hour monthly&#xD;
      guidance for six months. A seven-month educational intervention will be performed, and due to&#xD;
      ethical issues the control group will receive the same intervention after the second&#xD;
      follow-up. Effects will be measured on resident and care staff level at baseline before&#xD;
      randomization, after the intervention (7 months) and at follow-up (7 months later) of the&#xD;
      intervention group.&#xD;
&#xD;
      An analysis of how many units needs to be included are based on 12+12 clusters. Two&#xD;
      calculations have been performed. The first calculation is based on how big is the reduction&#xD;
      in use of restraints. We assume in our model that there will be a 60 % reduction in use of&#xD;
      restraints in the intervention group and 33 % reduction in the control group (Hawthorne&#xD;
      effect). For this reason we need to include averagely 13 patients in each department/unit in&#xD;
      order to achieve a statistical power of 0,8.&#xD;
&#xD;
      Measures on resident will be collected by a skilled research nurse blind to the study. Care&#xD;
      staff measures will be collected through a questionnaire distributed directly to the care&#xD;
      staff, provided with a stamped envelope to return the questionnaire directly to the research&#xD;
      group. In addition, department characteristics (like type of department, staff coverage,&#xD;
      architecture) will be registered.&#xD;
&#xD;
      A research team will lead the EI, and four facilitator teams each consisting of one nurse and&#xD;
      one assistant professor from a nursing schools will be responsible for the EI of the&#xD;
      decision-making model in the NHs. The Educational intervention will be carried out in two&#xD;
      steps, firstly from researchers to the educators (EI 1) and secondly from the educators to&#xD;
      the NH staff (EI 2)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2011</start_date>
  <completion_date type="Actual">August 2015</completion_date>
  <primary_completion_date type="Actual">August 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Restraint change</measure>
    <time_frame>Assessment in 6-8 months, publication in approximately 18-20 months</time_frame>
    <description>Use of restraint be assessed by a trained research assistant, employing a form specifically developed for this project, assessing use of restraint.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Psychotropic drug change</measure>
    <time_frame>Assessment in 6-8 months, publication in approximately 18-20 months</time_frame>
    <description>Use of psychotropic drugs will be assessed by a trained research assistant, registering the total medication of the patients from the patient chart.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">274</enrollment>
  <condition>Dementia</condition>
  <condition>Agitation</condition>
  <arm_group>
    <arm_group_label>Educational intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Educational intervention with two days of lecture/course for the whole staff in the selected department in each nursing home and six monthly sessions of counselling in smaller groups</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Educational intervention</intervention_name>
    <description>The educational intervention (EI), Relation Related Care (RRC), consists of a two-day seminar and one hour monthly guidance for six months. Course material, a book particularly designed for this intervention and dealing with person centered care and use of restraint, is distributed ahead of the course part of the intervention to all participants.</description>
    <arm_group_label>Educational intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Dementia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  non-dementia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>105 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Frode F Jacobsen, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Bergen University College</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Flora Omsorgssenter</name>
      <address>
        <city>Florø</city>
        <state>Flora</state>
        <zip>6900</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Furuhaugane Omsorgssenter</name>
      <address>
        <city>Florø</city>
        <state>Flora</state>
        <zip>6900</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Solas bo- og rehabiliteringssenter</name>
      <address>
        <city>Ålgård</city>
        <state>Gjesdal</state>
        <zip>4330</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Husnestunet</name>
      <address>
        <city>Rosendal</city>
        <state>Kvinnherad</state>
        <zip>5470</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rosendalstunet</name>
      <address>
        <city>Rosendal</city>
        <state>Kvinnherad</state>
        <zip>5470</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kvitsoy kombisenter</name>
      <address>
        <city>Stavanger</city>
        <state>Kvitsoy</state>
        <zip>4180</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Luster Sjukeheimsteneste, avd. Gaupne</name>
      <address>
        <city>Sogndal</city>
        <state>Luster</state>
        <zip>6868</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Samnangerheimen</name>
      <address>
        <city>Bergen</city>
        <state>Samnanger</state>
        <zip>5650</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ask bo- og omsorgssenter</name>
      <address>
        <city>Askoy</city>
        <zip>5307</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stiftelsen Nykirkehjemmet</name>
      <address>
        <city>Bergen</city>
        <zip>5005</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Landaas Meninghets Eldresenter</name>
      <address>
        <city>Bergen</city>
        <zip>5097</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Midtbygda sykehjem</name>
      <address>
        <city>Bergen</city>
        <zip>5873</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teiglandshagen bufellesskap</name>
      <address>
        <city>Bomlo</city>
        <zip>5440</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bygdaheimen</name>
      <address>
        <city>Eidfjord</city>
        <zip>5783</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gulen Sjukeheim</name>
      <address>
        <city>Gulen</city>
        <zip>5966</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Laerdal Alders- og Sjukeheim</name>
      <address>
        <city>Laerdal</city>
        <zip>6887</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Roldal pleie og omsorgstjeneste</name>
      <address>
        <city>Odda</city>
        <zip>5760</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Byhagen Bo og Aktivitetssenter</name>
      <address>
        <city>Sandnes</city>
        <zip>4307</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sogndal Omsorgssenter</name>
      <address>
        <city>Sogndal</city>
        <zip>6856</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bergåstjern Sykehjem</name>
      <address>
        <city>Stavanger</city>
        <zip>4016</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boganes Bokollektiv</name>
      <address>
        <city>Stavanger</city>
        <zip>4032</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oyane Sykehjem</name>
      <address>
        <city>Stavanger</city>
        <zip>4085</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tysnes Sjukeheim</name>
      <address>
        <city>Tysnes</city>
        <zip>5685</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tysvaertunet</name>
      <address>
        <city>Tysvaer</city>
        <zip>5575</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>July 2016</verification_date>
  <study_first_submitted>October 25, 2012</study_first_submitted>
  <study_first_submitted_qc>October 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 29, 2012</study_first_posted>
  <last_update_submitted>July 22, 2016</last_update_submitted>
  <last_update_submitted_qc>July 22, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 25, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Bergen University College</investigator_affiliation>
    <investigator_full_name>Frode F. Jacobsen</investigator_full_name>
    <investigator_title>Professor, Director</investigator_title>
  </responsible_party>
  <keyword>Dementia</keyword>
  <keyword>Resident</keyword>
  <keyword>Nursinghome</keyword>
  <keyword>Use of restraint</keyword>
  <keyword>Agitation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dementia</mesh_term>
    <mesh_term>Psychomotor Agitation</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/NCT01715506
org study id: 2012/304
nct id: NCT01715506
lead sponsor: 
collaborator: 
has dmc: Yes
This is a single-blinded controlled cluster-randomized intervention trial recruiting staff
      from 24 NHs in three counties in the region of Western Norway, randomly selected from the
      total NH population in the region. A cluster is defined as a working ward of a larger NH,
      without shared facilities or staff. The 24 NHs are randomized into two groups, for
      intervention (12) and control (12). One department in each is selected for intervention and
      data collection will take place also in one department in each of the NHs in the control
      group. Hence the analyzed units (clusters) are NH departments. The educational intervention
      (EI), Relation Related Care (RRC), consists of a two-day seminar and one hour monthly
      guidance for six months. A seven-month educational intervention will be performed, and due to
      ethical issues the control group will receive the same intervention after the second
      follow-up. Effects will be measured on resident and care staff level at baseline before
      randomization, after the intervention (7 months) and at follow-up (7 months later) of the
      intervention group.
Purpose:

      Dementia is a major challenge for our society. In Norway, around 40 % of persons suffering
      from dementia live in nursing homes (NH), and the majority experiences severe functional
      impairments and complex needs including associated behavioral changes. International studies
      indicate that NH residents with cognitive impairment and high dependency are most likely to
      be restrained physically. There is evidence of various adverse effects such as injuries,
      reduced psychological well-being or decreased mobility related to the use of physical
      restraint. Moreover, in addition to ethical and professional arguments, there is evidence
      supporting that user-involvement and shared decision-making have positive effects for both
      residents and staff. The aim of the present study (MEDCED) is to carry out an educational
      intervention in care staff to test its potential effect on use of restraint in NH residents
      with dementia and increase job-satisfaction in care staff.

      Description:

      This is a single-blinded controlled cluster-randomized intervention trial recruiting staff
      from 24 NHs in three counties in the region of Western Norway, randomly selected from the
      total NH population in the region. A cluster is defined as a working ward of a larger NH,
      without shared facilities or staff. The 24 NHs are randomized into two groups, for
      intervention (12) and control (12). One department in each is selected for intervention and
      data collection will take place also in one department in each of the NHs in the control
      group. Hence the analyzed units (clusters) are NH departments. The educational intervention
      (EI), Relation Related Care (RRC), consists of a two-day seminar and one hour monthly
      guidance for six months. A seven-month educational intervention will be performed, and due to
      ethical issues the control group will receive the same intervention after the second
      follow-up. Effects will be measured on resident and care staff level at baseline before
      randomization, after the intervention (7 months) and at follow-up (7 months later) of the
      intervention group.

      An analysis of how many units needs to be included are based on 12+12 clusters. Two
      calculations have been performed. The first calculation is based on how big is the reduction
      in use of restraints. We assume in our model that there will be a 60 % reduction in use of
      restraints in the intervention group and 33 % reduction in the control group (Hawthorne
      effect). For this reason we need to include averagely 13 patients in each department/unit in
      order to achieve a statistical power of 0,8.

      Measures on resident will be collected by a skilled research nurse blind to the study. Care
      staff measures will be collected through a questionnaire distributed directly to the care
      staff, provided with a stamped envelope to return the questionnaire directly to the research
      group. In addition, department characteristics (like type of department, staff coverage,
      architecture) will be registered.

      A research team will lead the EI, and four facilitator teams each consisting of one nurse and
      one assistant professor from a nursing schools will be responsible for the EI of the
      decision-making model in the NHs. The Educational intervention will be carried out in two
      steps, firstly from researchers to the educators (EI 1) and secondly from the educators to
      the NH staff (EI 2)
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: Single (Participant)
measure: Restraint change
time frame: Assessment in 6-8 months, publication in approximately 18-20 months
description: Use of restraint be assessed by a trained research assistant, employing a form specifically developed for this project, assessing use of restraint.
measure: Psychotropic drug change
time frame: Assessment in 6-8 months, publication in approximately 18-20 months
description: Use of psychotropic drugs will be assessed by a trained research assistant, registering the total medication of the patients from the patient chart.
arm group label: Educational intervention
arm group type: Experimental
description: Educational intervention with two days of lecture/course for the whole staff in the selected department in each nursing home and six monthly sessions of counselling in smaller groups
intervention type: Behavioral
intervention name: Educational intervention
description: The educational intervention (EI), Relation Related Care (RRC), consists of a two-day seminar and one hour monthly guidance for six months. Course material, a book particularly designed for this intervention and dealing with person centered care and use of restraint, is distributed ahead of the course part of the intervention to all participants.
arm group label: Educational intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: 105 Years
healthy volunteers: No
last name: Frode F Jacobsen, PhD
role: Study Director
affiliation: Bergen University College
facility: 
facility: 
facility: 
facility: 
facility: 
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facility: 
facility: 
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facility: 
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country: Norway
responsible party type: Principal Investigator
investigator affiliation: Bergen University College
investigator full name: Frode F. Jacobsen
investigator title: Professor, Director
mesh term: Dementia
mesh term: Psychomotor Agitation