<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/NCT01681641</url>
  </required_header>
  <id_info>
    <org_study_id>AUHN-0211-AH</org_study_id>
    <nct_id>NCT01681641</nct_id>
  </id_info>
  <brief_title>Managing Changes in Life After Deep Brain Stimulation for Parkinson's Disease</brief_title>
  <official_title>Managing Changes in Life After Deep Brain Stimulation for Parkinson's Disease - Designing and Developing a Targeted Nursing Program to Patients and Spouses.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Aarhus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Aarhus University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Aarhus</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Parkinson's disease is a chronic progressive neurological disorder. Symptoms are tremor,&#xD;
      slowness in movement, rigidity and postural instability. As the disease progresses and&#xD;
      treatment with L-dopa is no longer sufficient, some patients may be treated with deep brain&#xD;
      stimulation.&#xD;
&#xD;
      When treated with deep brain stimulation, electrodes are inserted in the affected area of the&#xD;
      brain and through stimulation, motor symptoms of Parkinson's disease are significantly&#xD;
      reduced.&#xD;
&#xD;
      During the first year of DBS treatment patients and spouses may experience changes in&#xD;
      everyday life and illness trajectory posing new opportunities as well as new challenges.&#xD;
&#xD;
      The purpose of the study is to develop an individualised and targeted nursing program to&#xD;
      support patients and relatives manage changes and challenges in life the first three months&#xD;
      after Deep Brain Stimulation. The intervention is expected to generate important knowledge&#xD;
      that will serve as a foundation for the further development of a future nursing program.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The intervention is designed as a psychosocial intervention, targeted both patients and&#xD;
      spouses.&#xD;
&#xD;
      The intervention consists of individually targeted meetings with a specialized DBS nurse&#xD;
      several times during the first six months og DBS. Patients and spouses likewise have to fill&#xD;
      out a diary for use in the meetings.&#xD;
&#xD;
      All meetings have specific topics, addressing aspects of challenges in adjusting to DBS, and&#xD;
      the aim is to off patients and spouses a tailored intervention, supporting each individual&#xD;
      based on an individual assessment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2011</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in sense of Coherence in intervention group compared to control group</measure>
    <time_frame>Baseline, 6 months, 12 months</time_frame>
    <description>Questionnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>Baseline, 6 months, 12 months</time_frame>
    <description>PDQ 39 or PDQ Carer</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Qualitative interviews</measure>
    <time_frame>12 months</time_frame>
    <description>Patients and spouses experience of participating in the intervention. Perceived use of knowledge gained</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Parkinson's Disease</condition>
  <arm_group>
    <arm_group_label>Lifestyle counseling</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients and spouses in the intervention group are offered 3 targeted meetings with the DBS nurse, focusing on goal setting for each individual, following DBS, based on patients and spouses own expectations, challenges and goals for everyday life after DBS.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients and spouses enrolled in a control group</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>A psycho-social intervention</intervention_name>
    <arm_group_label>Lifestyle counseling</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  eligible and offered treatment with DBS for PD&#xD;
&#xD;
          -  married or cohabitant&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  living alone&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anita Haahr, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Neurology, Aarhus University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Neurology, Aarhus University Hospital</name>
      <address>
        <city>Aarhus</city>
        <state>Jutland</state>
        <zip>8000 C</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Neurology , Aarhus University Hospital</name>
      <address>
        <city>Aarhus</city>
        <zip>8000 C</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bispebjerg Hospital</name>
      <address>
        <city>København</city>
        <zip>2300</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>August 13, 2012</study_first_submitted>
  <study_first_submitted_qc>September 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2012</study_first_posted>
  <last_update_submitted>May 28, 2017</last_update_submitted>
  <last_update_submitted_qc>May 28, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 31, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Patients</keyword>
  <keyword>Nursing</keyword>
  <keyword>Parkinsons disease</keyword>
  <keyword>Deep Brain Stimulation</keyword>
  <keyword>Spouses</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</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/NCT01681641
org study id: AUHN-0211-AH
nct id: NCT01681641
lead sponsor: 
collaborator: 
has dmc: No
Parkinson's disease is a chronic progressive neurological disorder. Symptoms are tremor,
      slowness in movement, rigidity and postural instability. As the disease progresses and
      treatment with L-dopa is no longer sufficient, some patients may be treated with deep brain
      stimulation.

      When treated with deep brain stimulation, electrodes are inserted in the affected area of the
      brain and through stimulation, motor symptoms of Parkinson's disease are significantly
      reduced.

      During the first year of DBS treatment patients and spouses may experience changes in
      everyday life and illness trajectory posing new opportunities as well as new challenges.

      The purpose of the study is to develop an individualised and targeted nursing program to
      support patients and relatives manage changes and challenges in life the first three months
      after Deep Brain Stimulation. The intervention is expected to generate important knowledge
      that will serve as a foundation for the further development of a future nursing program.
The intervention is designed as a psychosocial intervention, targeted both patients and
      spouses.

      The intervention consists of individually targeted meetings with a specialized DBS nurse
      several times during the first six months og DBS. Patients and spouses likewise have to fill
      out a diary for use in the meetings.

      All meetings have specific topics, addressing aspects of challenges in adjusting to DBS, and
      the aim is to off patients and spouses a tailored intervention, supporting each individual
      based on an individual assessment.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Change in sense of Coherence in intervention group compared to control group
time frame: Baseline, 6 months, 12 months
description: Questionnaire
measure: Quality of life
time frame: Baseline, 6 months, 12 months
description: PDQ 39 or PDQ Carer
measure: Qualitative interviews
time frame: 12 months
description: Patients and spouses experience of participating in the intervention. Perceived use of knowledge gained
arm group label: Lifestyle counseling
arm group type: Experimental
description: Patients and spouses in the intervention group are offered 3 targeted meetings with the DBS nurse, focusing on goal setting for each individual, following DBS, based on patients and spouses own expectations, challenges and goals for everyday life after DBS.
arm group label: Control group
arm group type: No Intervention
description: Patients and spouses enrolled in a control group
intervention type: Other
intervention name: A psycho-social intervention
arm group label: Lifestyle counseling
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Anita Haahr, PHD
role: Principal Investigator
affiliation: Department of Neurology, Aarhus University Hospital
facility: 
facility: 
facility: 
country: Denmark
responsible party type: Sponsor
mesh term: Parkinson Disease
sharing ipd: No