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/NCT05988866</url>
    </required_header>
    <id_info>
      <org_study_id>lipodia RCT 2024</org_study_id>
      <nct_id>NCT05988866</nct_id>
    </id_info>
    <brief_title>Effects of a Digital Health Application (Lipodia) on LDL-cholesterol Levels</brief_title>
    <acronym>DIGICHOL</acronym>
    <official_title>Effects of a Digital Health Application (Lipodia) on LDL-cholesterol Levels in Individuals With LDL-cholesterol Levels Above Recommended Targets for Reducing Cardiovascular Risk: Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Gaia AG</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University Hospital, Aachen</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Deutsche Stiftung für chronisch Kranke</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 pragmatic randomized controlled trial (RCT) with 272 patients with hypercholesterolemia&#xD;
        aims to investigate the effectiveness of lipodia, an unguided digital health intervention for&#xD;
        patients with hypercholesterolemia on plasma lipid levels and other clinical variables.&#xD;
        Inclusion criteria are: age ≥ 18 years, presence of hypercholesterolemia, low-density&#xD;
        lipoprotein cholesterol (LDL-C) levels above the risk-adapted target, stability of potential&#xD;
        drug treatments for at least four weeks, and stability of potential hormonal treatment for at&#xD;
        least 6 months, next to provision of informed consent and sufficient knowledge of the German&#xD;
        language. Exclusion criteria are plans to change potential drug treatment in the upcoming 6&#xD;
        months, the presence of homozygous familial hypercholesterolemia (FH) or type III&#xD;
        hyperlipidemia, receiving plasmapheresis, Lp(a) &gt; 50 mg/dL, triglyceride (TG) above 400&#xD;
        mg/dL, current pregnancy, planned major operations, liver dysfunction, end-stage renal&#xD;
        failure, and other systemic diseases that might interfere with successful study&#xD;
        participation.&#xD;
  &#xD;
        Patients will be randomized and allocated to either an intervention group, in which they will&#xD;
        receive access to lipodia in addition to treatment as usual (TAU), or to a control group, in&#xD;
        which they will receive only TAU.&#xD;
  &#xD;
        The primary endpoint will be a change in plasma LDL-C levels, with six months post-allocation&#xD;
        (T2) being the primary timepoint for assessment of effectiveness. Three months&#xD;
        post-allocation (T1) will serve as early-response assessment of endpoints. Secondary&#xD;
        endpoints will be patient activation, the change in levels of other plasma lipids&#xD;
        (non-high-density lipoprotein cholesterol (non-HDL-C), high-density lipoprotein cholesterol&#xD;
        (HDL), TG), responder rate of LDL-C, self-reported health-related quality of life, and BMI.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">January 2024</start_date>
    <completion_date type="Anticipated">July 2025</completion_date>
    <primary_completion_date type="Anticipated">January 2025</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>Double (Investigator, Outcomes Assessor)</masking>
      <masking_description>Study visit staff and the laboratory are blinded regarding the patient's study group.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Percent change in fasting LDL-C levels from baseline</measure>
      <time_frame>6 months</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Patients' activation</measure>
      <time_frame>6 months</time_frame>
      <description>PAM-13</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percent change in fasting non-HDL-C levels from baseline</measure>
      <time_frame>6 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percent change in fasting triglyceride levels from baseline</measure>
      <time_frame>6 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Responder analysis for LDL-C levels</measure>
      <time_frame>6 months</time_frame>
      <description>% of patients reaching risk-adapted target</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percent change in fasting HDL-C levels from baseline</measure>
      <time_frame>6 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Health-related quality of life</measure>
      <time_frame>6 months</time_frame>
      <description>AQoL-8D</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>BMI</measure>
      <time_frame>6 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percent change in fasting LDL-C levels from baseline</measure>
      <time_frame>3 months</time_frame>
    </secondary_outcome>
    <other_outcome>
      <measure>Patients' activation</measure>
      <time_frame>3 months</time_frame>
      <description>PAM-13</description>
    </other_outcome>
    <other_outcome>
      <measure>Percent change in fasting non-HDL-C levels from baseline</measure>
      <time_frame>3 months</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Percent change in fasting triglyceride levels from baseline</measure>
      <time_frame>3 months</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Percent change in fasting HDL-C levels from baseline</measure>
      <time_frame>3 months</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Responder analysis for LDL-C levels</measure>
      <time_frame>3 months</time_frame>
      <description>% of patients reaching risk-adapted target</description>
    </other_outcome>
    <other_outcome>
      <measure>Health-related quality of life</measure>
      <time_frame>3 months</time_frame>
      <description>AQoL-8D</description>
    </other_outcome>
    <other_outcome>
      <measure>BMI</measure>
      <time_frame>3 months</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Health literacy</measure>
      <time_frame>6 months</time_frame>
      <description>HLQ</description>
    </other_outcome>
    <other_outcome>
      <measure>Perceived efficacy in patient-physician-interactions</measure>
      <time_frame>6 months</time_frame>
      <description>PEPPI-5</description>
    </other_outcome>
    <other_outcome>
      <measure>Autonomy preference</measure>
      <time_frame>6 months</time_frame>
      <description>API</description>
    </other_outcome>
    <other_outcome>
      <measure>Percent change in fasting remnant cholesterol levels (non-HDL-C minus LDL-C)</measure>
      <time_frame>6 months</time_frame>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">272</enrollment>
    <condition>Hypercholesterolemia</condition>
    <condition>Dyslipidemias</condition>
    <arm_group>
      <arm_group_label>Intervention group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants allocated to the intervention group will receive access to lipodia in addition to treatment as usual (TAU).&#xD;
  lipodia is a digital health application designed for individuals with hypercholesterinemia, accessible through a web browser. The application focuses on treatment methods derived health behavior change and cognitive behavioral therapy (CBT). Topics addressed by lipodia are activity planning and impulse control, dietary habits, physical activity, stress management, mood management, sleep management, weight management, as well as quitting smoking and drinking.&#xD;
  The program operates through interactive &quot;dialogues&quot;, which are accompanied by illustrations, audio recordings, motivating text messages, worksheets, and summaries. Users are also encouraged to regularly complete short questionnaires to monitor their complaints. Once registered, the program remains accessible for 365 days.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</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>lipodia</intervention_name>
      <description>Participants will receive access to the digital health intervention lipodia in addition to TAU.</description>
      <arm_group_label>Intervention group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age &gt;= 18&#xD;
  &#xD;
            -  Of legal age (can differ from 18 in case the patient's nationality is not German)&#xD;
  &#xD;
            -  Diagnosis of hypercholesterolemia (ICD-10 E78.0, E78.2, E78.4, E78.5, E78.8, E78.9)&#xD;
               confirmed by a laboratory test and physician diagnosis&#xD;
  &#xD;
            -  LDL-C levels above risk-adapted target&#xD;
  &#xD;
            -  triglyceride levels &lt; 400 mg/dL&#xD;
  &#xD;
            -  Stability of potential drug treatment during the last 4 weeks&#xD;
  &#xD;
            -  Stability of potential hormonal treatment during the last 6 months&#xD;
  &#xD;
            -  Consent to participation&#xD;
  &#xD;
            -  Sufficient knowledge of the German language&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Homozygous Familial Hypercholesterolemia (FH), given that it is a genetic condition&#xD;
               which is relatively unresponsive to lifestyle changes&#xD;
  &#xD;
            -  Hyperlipidemia type III, given that it is a genetic condition which is relatively&#xD;
               unresponsive to lifestyle changes&#xD;
  &#xD;
            -  Patients receiving plasmapheresis&#xD;
  &#xD;
            -  Lp(a) &gt; 50 mg/dL&#xD;
  &#xD;
            -  Current pregnancy&#xD;
  &#xD;
            -  Planned major operations&#xD;
  &#xD;
            -  Liver dysfunction&#xD;
  &#xD;
            -  End-stage renal failure&#xD;
  &#xD;
            -  Other systemic conditions that might interfere with successful study participation&#xD;
  &#xD;
            -  Plans to change drug treatment in the upcoming 6 months&#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>Dirk Müller-Wieland, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Klinisches Studienzentrum, Medizinische Klinik I, Universitätsklinikum Aachen, Pauwelsstraße 30, 52074 Aachen</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Björn Meyer, PhD</last_name>
      <phone>+49.176.1039.2337</phone>
      <email>bjoern.meyer@gaia-group.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Antje Riepenhausen, M.Sc.</last_name>
      <email>antje.riepenhausen@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>
      <contact>
        <last_name>Björn Meyer, PhD</last_name>
        <email>bjoern.meyer@gaia-group.com</email>
      </contact>
      <contact_backup>
        <last_name>Antje Riepenhausen, M.Sc.</last_name>
        <email>antje.riepenhausen@gaia-group.com</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Germany</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 3, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>LDL-C</keyword>
    <keyword>digital intervention</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hypercholesterolemia</mesh_term>
      <mesh_term>Dyslipidemias</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/NCT05988866
  org study id: lipodia RCT 2024
  nct id: NCT05988866
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This pragmatic randomized controlled trial (RCT) with 272 patients with hypercholesterolemia
        aims to investigate the effectiveness of lipodia, an unguided digital health intervention for
        patients with hypercholesterolemia on plasma lipid levels and other clinical variables.
        Inclusion criteria are: age ≥ 18 years, presence of hypercholesterolemia, low-density
        lipoprotein cholesterol (LDL-C) levels above the risk-adapted target, stability of potential
        drug treatments for at least four weeks, and stability of potential hormonal treatment for at
        least 6 months, next to provision of informed consent and sufficient knowledge of the German
        language. Exclusion criteria are plans to change potential drug treatment in the upcoming 6
        months, the presence of homozygous familial hypercholesterolemia (FH) or type III
        hyperlipidemia, receiving plasmapheresis, Lp(a) > 50 mg/dL, triglyceride (TG) above 400
        mg/dL, current pregnancy, planned major operations, liver dysfunction, end-stage renal
        failure, and other systemic diseases that might interfere with successful study
        participation.
  
        Patients will be randomized and allocated to either an intervention group, in which they will
        receive access to lipodia in addition to treatment as usual (TAU), or to a control group, in
        which they will receive only TAU.
  
        The primary endpoint will be a change in plasma LDL-C levels, with six months post-allocation
        (T2) being the primary timepoint for assessment of effectiveness. Three months
        post-allocation (T1) will serve as early-response assessment of endpoints. Secondary
        endpoints will be patient activation, the change in levels of other plasma lipids
        (non-high-density lipoprotein cholesterol (non-HDL-C), high-density lipoprotein cholesterol
        (HDL), TG), responder rate of LDL-C, self-reported health-related quality of life, and BMI.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Investigator, Outcomes Assessor)
  masking description: Study visit staff and the laboratory are blinded regarding the patient's study group.
  measure: Percent change in fasting LDL-C levels from baseline
  time frame: 6 months
  measure: Patients' activation
  time frame: 6 months
  description: PAM-13
  measure: Percent change in fasting non-HDL-C levels from baseline
  time frame: 6 months
  measure: Percent change in fasting triglyceride levels from baseline
  time frame: 6 months
  measure: Responder analysis for LDL-C levels
  time frame: 6 months
  description: % of patients reaching risk-adapted target
  measure: Percent change in fasting HDL-C levels from baseline
  time frame: 6 months
  measure: Health-related quality of life
  time frame: 6 months
  description: AQoL-8D
  measure: BMI
  time frame: 6 months
  measure: Percent change in fasting LDL-C levels from baseline
  time frame: 3 months
  measure: Patients' activation
  time frame: 3 months
  description: PAM-13
  measure: Percent change in fasting non-HDL-C levels from baseline
  time frame: 3 months
  measure: Percent change in fasting triglyceride levels from baseline
  time frame: 3 months
  measure: Percent change in fasting HDL-C levels from baseline
  time frame: 3 months
  measure: Responder analysis for LDL-C levels
  time frame: 3 months
  description: % of patients reaching risk-adapted target
  measure: Health-related quality of life
  time frame: 3 months
  description: AQoL-8D
  measure: BMI
  time frame: 3 months
  measure: Health literacy
  time frame: 6 months
  description: HLQ
  measure: Perceived efficacy in patient-physician-interactions
  time frame: 6 months
  description: PEPPI-5
  measure: Autonomy preference
  time frame: 6 months
  description: API
  measure: Percent change in fasting remnant cholesterol levels (non-HDL-C minus LDL-C)
  time frame: 6 months
  arm group label: Intervention group
  arm group type: Experimental
  description: Participants allocated to the intervention group will receive access to lipodia in addition to treatment as usual (TAU).
  lipodia is a digital health application designed for individuals with hypercholesterinemia, accessible through a web browser. The application focuses on treatment methods derived health behavior change and cognitive behavioral therapy (CBT). Topics addressed by lipodia are activity planning and impulse control, dietary habits, physical activity, stress management, mood management, sleep management, weight management, as well as quitting smoking and drinking.
  The program operates through interactive "dialogues", which are accompanied by illustrations, audio recordings, motivating text messages, worksheets, and summaries. Users are also encouraged to regularly complete short questionnaires to monitor their complaints. Once registered, the program remains accessible for 365 days.
  arm group label: Control group
  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: lipodia
  description: Participants will receive access to the digital health intervention lipodia in addition to TAU.
  arm group label: Intervention group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Dirk Müller-Wieland, MD
  role: Principal Investigator
  affiliation: Klinisches Studienzentrum, Medizinische Klinik I, Universitätsklinikum Aachen, Pauwelsstraße 30, 52074 Aachen
  last name: Björn Meyer, PhD
  phone: +49.176.1039.2337
  email: bjoern.meyer@gaia-group.com
  last name: Antje Riepenhausen, M.Sc.
  email: antje.riepenhausen@gaia-group.com
  facility: 
  contact: 
  contact backup: 
  country: Germany
  responsible party type: Sponsor
  mesh term: Hypercholesterolemia
  mesh term: Dyslipidemias
  sharing ipd: No