xml: <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/NCT06027034</url>
    </required_header>
    <id_info>
      <org_study_id>Psoriasis RCT 2023</org_study_id>
      <nct_id>NCT06027034</nct_id>
    </id_info>
    <brief_title>Effectiveness of a Digital Health Application for Psoriasis</brief_title>
    <official_title>Effectiveness of a Digital Health Application for Psoriasis: Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Gaia AG</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University of Giessen</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Universitätsklinikum Hamburg-Eppendorf</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Gaia AG</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>
        This clinical trial with 348 patients with psoriasis aims to investigate the effectiveness of&#xD;
        a self-guided online program for patients with psoriasis.&#xD;
  &#xD;
        Patients will be randomized and allocated in a 1:1 ratio to either an intervention group, in&#xD;
        which they will receive 12-month-access to an online program for psoriasis in addition to&#xD;
        treatment as usual (TAU, n = 174), or to a control group, in which they will receive only TAU&#xD;
        (n = 174). TAU is defined as any therapy prescribed or recommended by the GP or specialists&#xD;
        (e.g. dermatologist, psychiatrist), which may include topical therapy, phototherapy,&#xD;
        pharmacotherapy, psychosocial therapy, etc.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">March 2025</completion_date>
    <primary_completion_date type="Anticipated">June 2024</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 (Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Health-Related Quality of Life</measure>
      <time_frame>3 months</time_frame>
      <description>Total score of the Dermatology Life Quality Index (DLQI). Total score ranging from 0-30; higher scores mean a worse outcome.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Psoriasis Severity</measure>
      <time_frame>3 months, 6 months, 12 months</time_frame>
      <description>Total score of the Self-Administered Psoriasis Area Severity Index (PASI). Total score ranging from 0-72; higher scores mean a worse outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Depressive Symptoms</measure>
      <time_frame>3 months, 6 months, 12 months</time_frame>
      <description>Total score of the Patient Health Questionnaire (PHQ-9). Total score ranging from 0-27; higher scores mean a worse outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Body Surface Area (BSA)</measure>
      <time_frame>3 months, 6 months, 12 months</time_frame>
      <description>Body Surface Area (BSA) is a measure used to determine the extent of skin involvement in psoriasis. Total score ranging from 0-100; higher scores mean a worse outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Health-Related Quality of Life</measure>
      <time_frame>6 months, 12 months</time_frame>
      <description>Total score of the Dermatology Life Quality Index (DLQI). Total score ranging from 0-30; higher scores mean a worse outcome.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Patient Activation</measure>
      <time_frame>3 months, 6 months, 12 months</time_frame>
      <description>Total score of the Patient Activation Measure-13 (PAM-13). Total score ranging from 0-100; higher scores mean a better outcome.</description>
    </other_outcome>
    <other_outcome>
      <measure>Self-Esteem</measure>
      <time_frame>3 months, 6 months, 12 months</time_frame>
      <description>Total score of the Rosenberg Self-Esteem Scale (RSE). Total score ranging from 0-30; higher scores mean a better outcome.</description>
    </other_outcome>
    <other_outcome>
      <measure>Body Mass Index</measure>
      <time_frame>3 months, 6 months, 12 months</time_frame>
      <description>Body mass index (BMI) is a simple measure of body fat based on height and weight. Higher values mean a worse outcome.</description>
    </other_outcome>
    <other_outcome>
      <measure>Alcohol Consumption</measure>
      <time_frame>3 months, 6 months, 12 months</time_frame>
      <description>Total score of the Alcohol use Disorders Identification Test - Consumption Items (AUDIT-C). Total score ranging from 0-12; higher scores mean a worse outcome.</description>
    </other_outcome>
    <other_outcome>
      <measure>Cigarette Smoking</measure>
      <time_frame>3 months, 6 months, 12 months</time_frame>
      <description>Cigarette smoking will be assessed with a single question 'How often do you smoke cigarettes?', with response options 'Never/rarely/sometimes/often/very often', coded from 0-4. Higher scores mean a worse outcome.</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">348</enrollment>
    <condition>Psoriasis</condition>
    <arm_group>
      <arm_group_label>Online program for psoriasis (GAIA-PSO-01) + TAU</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants allocated to the intervention group will receive access to an online program for psoriasis (GAIA-PSO-01) in addition to treatment as usual (TAU).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>TAU</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Participants allocated to the control group will receive access to treatment as usual (TAU).</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Online program for psoriasis (GAIA-PSO-01)</intervention_name>
      <description>The program to-be-tested (GAIA-PSO-01) is an interactive online program for independent use by users with psoriasis. It focuses on recognized treatment elements of cognitive behavioral therapy (CBT) and behavior change techniques.</description>
      <arm_group_label>Online program for psoriasis (GAIA-PSO-01) + TAU</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age ≥ 18 years&#xD;
  &#xD;
            -  Presence of psoriasis vulgaris or psoriatic arthritis&#xD;
  &#xD;
            -  Submission of a specialist medical certificate attesting to the presence of at least&#xD;
               one of the following ICD-10-GM diagnoses: Psoriasis vulgaris (L 40.0, L 40.7),&#xD;
               Psoriatic arthritis (L40.5, M07.x)&#xD;
  &#xD;
            -  Impaired health-related quality of life (DLQI &gt; 10)&#xD;
  &#xD;
            -  Consent to participate&#xD;
  &#xD;
            -  Sufficient understanding of the German language&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Presence of another subtype of psoriasis (pustular psoriasis, guttate psoriasis,&#xD;
               inverse psoriasis, erythrodermic psoriasis, or drug-induced psoriasis) or psoriatic&#xD;
               arthritis without skin involvement&#xD;
  &#xD;
            -  Presence of malignancies&#xD;
  &#xD;
            -  Presence of other chronic diseases with strong negative influence on quality of life&#xD;
  &#xD;
            -  Currently undergoing psychiatric treatment / current presence of a severe psychiatric&#xD;
               diagnosis&#xD;
  &#xD;
            -  Insufficient language and/or IT skills&#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>Uwe Gieler, Prof. Dr.</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Giessen</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Gitta Jacob, PD Dr.</last_name>
      <phone>+49.40.349930-374</phone>
      <email>gitta.jacob@gaia-group.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Linda Betz, Dr.</last_name>
      <email>linda.betz@gaia-group.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>GAIA AG</name>
        <address>
          <city>Hamburg</city>
          <zip>22085</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Gitta Jacob, PD Dr.</last_name>
        <email>gitta.jacob@gaia-group.com</email>
      </contact>
      <contact_backup>
        <last_name>Linda Betz, Dr.</last_name>
        <email>linda.betz@gaia-group.com</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Germany</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 31, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</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>Psoriasis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06027034
  org study id: Psoriasis RCT 2023
  nct id: NCT06027034
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This clinical trial with 348 patients with psoriasis aims to investigate the effectiveness of
        a self-guided online program for patients with psoriasis.
  
        Patients will be randomized and allocated in a 1:1 ratio to either an intervention group, in
        which they will receive 12-month-access to an online program for psoriasis in addition to
        treatment as usual (TAU, n = 174), or to a control group, in which they will receive only TAU
        (n = 174). TAU is defined as any therapy prescribed or recommended by the GP or specialists
        (e.g. dermatologist, psychiatrist), which may include topical therapy, phototherapy,
        pharmacotherapy, psychosocial therapy, etc.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Investigator)
  measure: Health-Related Quality of Life
  time frame: 3 months
  description: Total score of the Dermatology Life Quality Index (DLQI). Total score ranging from 0-30; higher scores mean a worse outcome.
  measure: Psoriasis Severity
  time frame: 3 months, 6 months, 12 months
  description: Total score of the Self-Administered Psoriasis Area Severity Index (PASI). Total score ranging from 0-72; higher scores mean a worse outcome.
  measure: Depressive Symptoms
  time frame: 3 months, 6 months, 12 months
  description: Total score of the Patient Health Questionnaire (PHQ-9). Total score ranging from 0-27; higher scores mean a worse outcome.
  measure: Body Surface Area (BSA)
  time frame: 3 months, 6 months, 12 months
  description: Body Surface Area (BSA) is a measure used to determine the extent of skin involvement in psoriasis. Total score ranging from 0-100; higher scores mean a worse outcome.
  measure: Health-Related Quality of Life
  time frame: 6 months, 12 months
  description: Total score of the Dermatology Life Quality Index (DLQI). Total score ranging from 0-30; higher scores mean a worse outcome.
  measure: Patient Activation
  time frame: 3 months, 6 months, 12 months
  description: Total score of the Patient Activation Measure-13 (PAM-13). Total score ranging from 0-100; higher scores mean a better outcome.
  measure: Self-Esteem
  time frame: 3 months, 6 months, 12 months
  description: Total score of the Rosenberg Self-Esteem Scale (RSE). Total score ranging from 0-30; higher scores mean a better outcome.
  measure: Body Mass Index
  time frame: 3 months, 6 months, 12 months
  description: Body mass index (BMI) is a simple measure of body fat based on height and weight. Higher values mean a worse outcome.
  measure: Alcohol Consumption
  time frame: 3 months, 6 months, 12 months
  description: Total score of the Alcohol use Disorders Identification Test - Consumption Items (AUDIT-C). Total score ranging from 0-12; higher scores mean a worse outcome.
  measure: Cigarette Smoking
  time frame: 3 months, 6 months, 12 months
  description: Cigarette smoking will be assessed with a single question 'How often do you smoke cigarettes?', with response options 'Never/rarely/sometimes/often/very often', coded from 0-4. Higher scores mean a worse outcome.
  arm group label: Online program for psoriasis (GAIA-PSO-01) + TAU
  arm group type: Experimental
  description: Participants allocated to the intervention group will receive access to an online program for psoriasis (GAIA-PSO-01) in addition to treatment as usual (TAU).
  arm group label: TAU
  arm group type: No Intervention
  description: Participants allocated to the control group will receive access to treatment as usual (TAU).
  intervention type: Behavioral
  intervention name: Online program for psoriasis (GAIA-PSO-01)
  description: The program to-be-tested (GAIA-PSO-01) is an interactive online program for independent use by users with psoriasis. It focuses on recognized treatment elements of cognitive behavioral therapy (CBT) and behavior change techniques.
  arm group label: Online program for psoriasis (GAIA-PSO-01) + TAU
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Uwe Gieler, Prof. Dr.
  role: Principal Investigator
  affiliation: University of Giessen
  last name: Gitta Jacob, PD Dr.
  phone: +49.40.349930-374
  email: gitta.jacob@gaia-group.com
  last name: Linda Betz, Dr.
  email: linda.betz@gaia-group.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Germany
  responsible party type: Sponsor
  mesh term: Psoriasis
  sharing ipd: No