<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/NCT03275649</url>
  </required_header>
  <id_info>
    <org_study_id>CityULondon_PDHelp</org_study_id>
    <nct_id>NCT03275649</nct_id>
  </id_info>
  <brief_title>Help-seeking for Health Problems in People With Parkinson's</brief_title>
  <acronym>PDHelp</acronym>
  <official_title>Development of an Intervention to Increase Help-seeking for Non-motor Symptoms in People With Parkinson's</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>City, University of London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>King's College London</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>King's College Hospital NHS Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>City, University of London</source>
  <oversight_info>
    <has_dmc>No</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>
      Non-motor symptoms (NMS) are common in Parkinson's disease (PD) and cause significant&#xD;
      distress and decreased quality of life. A high rate of non-declaration of NMS by patients&#xD;
      means that many NMS remain unrecognized and untreated, even in specialist clinical services.&#xD;
      In phase one of this research qualitative interviews (phase 1) were guided by the Theoretical&#xD;
      Domains Framework and used to identify the barriers for help-seeking. A quantitative&#xD;
      questionnaire survey (phase 2) examined the significance of these barriers to help seeking.&#xD;
      The present study aims to develop (phase 3) and test the feasibility (phase 4) of a targeted&#xD;
      behavioural intervention of barriers which were identified in phases 1 and 2 which prevent&#xD;
      help-seeking for NMS in patients with PD. As with phases 1 and 2, the feasibility trial will&#xD;
      include people with unreported burdensome NMS, who have not reported them to their PD&#xD;
      consultant or nurse. The intervention has been co-designed by people affected by Parkinson's&#xD;
      and targets the barriers identified in the previous phases of the research. In phase three of&#xD;
      the research, 'think-aloud' interviews will be used to further develop the intervention so&#xD;
      that it is acceptable and easy to use. In the final phase, a feasibility trial will be&#xD;
      conducted to examine efficacy of the intervention for increasing help-seeking for undeclared&#xD;
      NMS. The study has implications for using a theoretically driven behavioural intervention to&#xD;
      promote help-seeking for NMS and ultimately increase receipt of clinical care for NMS among&#xD;
      patients with PD.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 21, 2017</start_date>
  <completion_date type="Actual">January 1, 2018</completion_date>
  <primary_completion_date type="Actual">January 1, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of patients help-seeking post-intervention</measure>
    <time_frame>1 week</time_frame>
    <description>after intervention</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of eligible patients completing the study</measure>
    <time_frame>1 week</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">35</enrollment>
  <condition>Parkinson Disease</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Help-seeking for non-motor symptoms</intervention_name>
    <description>Brief, self-paced, online individually tailored intervention using LifeGuide software. Includes information, videos and exercises.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        -Participants diagnosed with idiopathic PD will be recruited through outpatient neurology&#xD;
        clinics and via the Parkinson's UK research network. Participants experiencing burdensome&#xD;
        undisclosed non-motor symptoms will be recruited into the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of idiopathic Parkinson's&#xD;
&#xD;
          -  Access to a computer and internet connection&#xD;
&#xD;
          -  Experiencing at least one unreported non-motor symptom&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of sensory loss or communication difficulty (including inadequate command of&#xD;
             English) sufficient to interfere with the assessments.&#xD;
&#xD;
          -  Severe cognitive impairment that would make participation in the intervention&#xD;
             problematic or distressing. This will be assessed using the Telephone Interview for&#xD;
             Cognitive Status-Modified (TICS-M, Brandt et al., 1993). People with a score of less&#xD;
             than 20 will be excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>City, University of London</name>
      <address>
        <city>London</city>
        <zip>EC1V 0HB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>August 29, 2017</study_first_submitted>
  <study_first_submitted_qc>September 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 7, 2017</study_first_posted>
  <last_update_submitted>January 29, 2018</last_update_submitted>
  <last_update_submitted_qc>January 29, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 30, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>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/NCT03275649
org study id: CityULondon_PDHelp
nct id: NCT03275649
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Non-motor symptoms (NMS) are common in Parkinson's disease (PD) and cause significant
      distress and decreased quality of life. A high rate of non-declaration of NMS by patients
      means that many NMS remain unrecognized and untreated, even in specialist clinical services.
      In phase one of this research qualitative interviews (phase 1) were guided by the Theoretical
      Domains Framework and used to identify the barriers for help-seeking. A quantitative
      questionnaire survey (phase 2) examined the significance of these barriers to help seeking.
      The present study aims to develop (phase 3) and test the feasibility (phase 4) of a targeted
      behavioural intervention of barriers which were identified in phases 1 and 2 which prevent
      help-seeking for NMS in patients with PD. As with phases 1 and 2, the feasibility trial will
      include people with unreported burdensome NMS, who have not reported them to their PD
      consultant or nurse. The intervention has been co-designed by people affected by Parkinson's
      and targets the barriers identified in the previous phases of the research. In phase three of
      the research, 'think-aloud' interviews will be used to further develop the intervention so
      that it is acceptable and easy to use. In the final phase, a feasibility trial will be
      conducted to examine efficacy of the intervention for increasing help-seeking for undeclared
      NMS. The study has implications for using a theoretically driven behavioural intervention to
      promote help-seeking for NMS and ultimately increase receipt of clinical care for NMS among
      patients with PD.
observational model: Other
time perspective: Prospective
measure: Proportion of patients help-seeking post-intervention
time frame: 1 week
description: after intervention
measure: Number of eligible patients completing the study
time frame: 1 week
intervention type: Other
intervention name: Help-seeking for non-motor symptoms
description: Brief, self-paced, online individually tailored intervention using LifeGuide software. Includes information, videos and exercises.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Parkinson Disease
sharing ipd: Undecided