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/NCT06025526</url>
    </required_header>
    <id_info>
      <org_study_id>23_5 ACTIVE-CaRe Pilot</org_study_id>
      <nct_id>NCT06025526</nct_id>
    </id_info>
    <brief_title>Effectiveness of the Aktivplan Digital Intervention (ACTIVE-CaRe Pilot)</brief_title>
    <official_title>Effectiveness of the Aktivplan Digital Intervention for Supporting Regular Heart-healthy Levels of Physical Activity Following Completion of a Phase II Rehabilitation Programme: a Clinical Pilot Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ludwig Boltzmann Institute for Digital Health and Prevention</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>REHA Zentrum Salzburg</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Reha-Klinik Montafon</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Ludwig Boltzmann Institute for Digital Health and Prevention</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>
        The goal of this clinical pilot / feasibility study is to determine the feasibility of&#xD;
        conducting a large-scale clinical effectiveness trial of the aktivplan digital intervention&#xD;
        in cardiac rehabilitation patients.&#xD;
  &#xD;
        The main questions this study aims to answer are:&#xD;
  &#xD;
          -  Is it feasible to conduct a large-scale (fully powered) effectiveness trial of the&#xD;
             aktivplan digital intervention?&#xD;
  &#xD;
          -  What is the usability, user experience and user acceptance of the aktivplan digital&#xD;
             intervention?&#xD;
  &#xD;
        Patients enrolled in a phase II cardiac rehabilitation programme will be randomly allocated&#xD;
        to either the intervention group (aktivplan digital intervention) ot the usual care control&#xD;
        group and followed-up for 10 weeks after discharge from cardiac rehabilitation.&#xD;
  &#xD;
        Patients in the intervention group will be given the aktivplan application (app) on their&#xD;
        smartphone. A rehabilitation professional will plan a personalised heart-healthy physical&#xD;
        activity plan together with the patient and enter it to the aktivplan app. The patient will&#xD;
        be asked to follow their personal physical activity plan for 10 weeks, using the aktivplan&#xD;
        app to document completed physical activity sessions.&#xD;
  &#xD;
        Patients in the control group will receive the usual standard of care without the aktivplan&#xD;
        digital intervention.&#xD;
  &#xD;
        Researchers will analyse information such as the rate of recruitment, participant attrition,&#xD;
        data completeness and technical stability of the app to determine the feasibility of&#xD;
        conducting a large-scale clinical effectiveness trial.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">May 2024</completion_date>
    <primary_completion_date type="Anticipated">May 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>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Recruitment rate</measure>
      <time_frame>10 weeks</time_frame>
      <description>Number of recruits per week</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Drop-out rate</measure>
      <time_frame>10 weeks</time_frame>
      <description>Number of drop-outs in at the 10-week follow-up visit</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Data completeness</measure>
      <time_frame>10 weeks</time_frame>
      <description>Percentage of missing data fields in the study database</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Adherence to the aktivplan digital intervention</measure>
      <time_frame>10 weeks</time_frame>
      <description>Automated usage logging of the aktivplan mobile application (Matomo platform)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Usability of the aktivplan digital intervention</measure>
      <time_frame>10 weeks</time_frame>
      <description>mHealth App Usability Questionnaire (MAUQ)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>User experience of the aktivplan digital intervention</measure>
      <time_frame>10 weeks</time_frame>
      <description>AttrakDiff Short Questionnaire</description>
    </primary_outcome>
    <primary_outcome>
      <measure>User acceptance of the aktivplan digital intervention</measure>
      <time_frame>10 weeks</time_frame>
      <description>Mobile Application Rating Scale (MARS)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Technical stability of the aktivplan digital intervention</measure>
      <time_frame>10 weeks</time_frame>
      <description>Number and types of technical problems (qualitative data)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Use of alternative and additional strategies for supporting physical activity</measure>
      <time_frame>10 weeks</time_frame>
      <description>Number and types of additional strategies (qualitative data)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Experiences and perspectives of patients regarding their study participation</measure>
      <time_frame>10 weeks</time_frame>
      <description>Qualitative data from semi-structured interviews</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Experiences and perspectives of rehabilitation professionals regarding the intervention and study procedures</measure>
      <time_frame>10 weeks</time_frame>
      <description>Qualitative data from focus groups</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Exercise capacity</measure>
      <time_frame>10 weeks</time_frame>
      <description>Incremental cycle ergometry test</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Physical activity behaviour</measure>
      <time_frame>10 weeks</time_frame>
      <description>Moderate to vigorous physical activity (MVPA)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Weight</measure>
      <time_frame>10 weeks</time_frame>
      <description>Weight in kg</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Blood pressure</measure>
      <time_frame>10 weeks</time_frame>
      <description>Blood pressure in mmHg</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Blood cholesterol</measure>
      <time_frame>10 weeks</time_frame>
      <description>Total cholesterol, HDL-cholesterol, non-HDL-cholesterol, total cholesterol / HDL-cholesterol ratio</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>HbA1c</measure>
      <time_frame>10 weeks</time_frame>
      <description>HbA1c level</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Smoking</measure>
      <time_frame>10 weeks</time_frame>
      <description>Number and type of smoking products per week (qualitative data)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Health-related quality of life</measure>
      <time_frame>10 weeks</time_frame>
      <description>EQ-5D-5L Questionnaire</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Exercise self-efficacy</measure>
      <time_frame>10 weeks</time_frame>
      <description>Exercise Self-Efficacy Scale (ESES)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient safety</measure>
      <time_frame>10 weeks</time_frame>
      <description>Adverse events reporting (number and severity of adverse events) assessed by the Medical Device Coordination Group (MDCG) form</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Cardiac Rehabilitation</condition>
    <condition>Secondary Prevention</condition>
    <condition>Cardiovascular Diseases</condition>
    <arm_group>
      <arm_group_label>Intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>Other</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>aktivplan</intervention_name>
      <description>The aktivplan digital intervention consists of a digital planning calendar for regular heart-healthy physical activity Towards the end of rehabilitation phase II, health professionals introduce aktivplan and plan a personalised physical activity plan together with their patients using shared decision-making. The physical activity plan is devised for the time after discharge from cardiac rehabilitation.&#xD;
  In the aktivplan smatphone app, the patient can view their personalised physical activity plan, check off completed activities, enter additional unplanned activities, and open short videos with exercise instructions.&#xD;
  Additional functions of aktivplan include patient-centered goal-setting, automated messages to the patient (motivational messages and reminders), and the possibility for health professionals to monitor all their patients' adherence to the physical activity plan and to contact individual patients directly via the app.</description>
      <arm_group_label>Intervention</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Usual care</intervention_name>
      <description>Usual care (standard of care) according to international and national cardiac rehabilitation guidelines.</description>
      <arm_group_label>Control</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Enrollment to a cardiac rehabilitation programme phase II, or a rehabilitation&#xD;
               programme phase II due to non-cardiac indication but displaying cardiovascular risk&#xD;
               factors&#xD;
  &#xD;
            -  Ownership and use of a smartphone compatible with the aktivplan digital intervention&#xD;
               and with internet connection&#xD;
  &#xD;
            -  Agreement to attend the study follow-up visit&#xD;
  &#xD;
            -  Written informed consent to take part in the study&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Existing use of a digital intervention for regular heart-healthy physical activity&#xD;
  &#xD;
            -  Medical contraindications for incremental cycle ergometry test&#xD;
  &#xD;
            -  Medical contraindications for regular heart-healthy physical activity and sports&#xD;
  &#xD;
            -  Medical contraindications for use of a smartphone&#xD;
  &#xD;
            -  Inability to carry out cardiovascular training (e.g., due to significant&#xD;
               musculoskeletal restrictions)&#xD;
  &#xD;
            -  Participation in another clinical study within the past 6 months&#xD;
  &#xD;
            -  Addiction or other medical conditions causing reduced decisional capacity&#xD;
  &#xD;
            -  Pregnant women in the third trimester&#xD;
  &#xD;
            -  Pregnant women in the first and second trimester with medical contraindication for&#xD;
               physical activity and sports&#xD;
  &#xD;
            -  Breastfeeding women with medical contraindication for physical activity and sports&#xD;
  &#xD;
            -  Indication that patient is unlikely to follow study procedures (limited cooperation)&#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>Stefan T Kulnik, PhD MRes</last_name>
      <role>Study Chair</role>
      <affiliation>Ludwig Boltzmann Institute for Digital Health and Prevention</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Stefan T Kulnik, PhD MRes</last_name>
      <phone>004357255</phone>
      <phone_ext>82712</phone_ext>
      <email>tino.kulnik@dhp.lbg.ac.at</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Franziska Pfannerstill, PhD MSc</last_name>
      <phone>004357255</phone>
      <phone_ext>82701</phone_ext>
      <email>franziska.pfannerstill@dhp.lbg.ac.at</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 23, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Digital Health</keyword>
    <keyword>Mobile Health</keyword>
    <keyword>Electronic health</keyword>
    <keyword>Smartphone App</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cardiovascular Diseases</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/NCT06025526
  org study id: 23_5 ACTIVE-CaRe Pilot
  nct id: NCT06025526
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical pilot / feasibility study is to determine the feasibility of
        conducting a large-scale clinical effectiveness trial of the aktivplan digital intervention
        in cardiac rehabilitation patients.
  
        The main questions this study aims to answer are:
  
          -  Is it feasible to conduct a large-scale (fully powered) effectiveness trial of the
             aktivplan digital intervention?
  
          -  What is the usability, user experience and user acceptance of the aktivplan digital
             intervention?
  
        Patients enrolled in a phase II cardiac rehabilitation programme will be randomly allocated
        to either the intervention group (aktivplan digital intervention) ot the usual care control
        group and followed-up for 10 weeks after discharge from cardiac rehabilitation.
  
        Patients in the intervention group will be given the aktivplan application (app) on their
        smartphone. A rehabilitation professional will plan a personalised heart-healthy physical
        activity plan together with the patient and enter it to the aktivplan app. The patient will
        be asked to follow their personal physical activity plan for 10 weeks, using the aktivplan
        app to document completed physical activity sessions.
  
        Patients in the control group will receive the usual standard of care without the aktivplan
        digital intervention.
  
        Researchers will analyse information such as the rate of recruitment, participant attrition,
        data completeness and technical stability of the app to determine the feasibility of
        conducting a large-scale clinical effectiveness trial.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Recruitment rate
  time frame: 10 weeks
  description: Number of recruits per week
  measure: Drop-out rate
  time frame: 10 weeks
  description: Number of drop-outs in at the 10-week follow-up visit
  measure: Data completeness
  time frame: 10 weeks
  description: Percentage of missing data fields in the study database
  measure: Adherence to the aktivplan digital intervention
  time frame: 10 weeks
  description: Automated usage logging of the aktivplan mobile application (Matomo platform)
  measure: Usability of the aktivplan digital intervention
  time frame: 10 weeks
  description: mHealth App Usability Questionnaire (MAUQ)
  measure: User experience of the aktivplan digital intervention
  time frame: 10 weeks
  description: AttrakDiff Short Questionnaire
  measure: User acceptance of the aktivplan digital intervention
  time frame: 10 weeks
  description: Mobile Application Rating Scale (MARS)
  measure: Technical stability of the aktivplan digital intervention
  time frame: 10 weeks
  description: Number and types of technical problems (qualitative data)
  measure: Use of alternative and additional strategies for supporting physical activity
  time frame: 10 weeks
  description: Number and types of additional strategies (qualitative data)
  measure: Experiences and perspectives of patients regarding their study participation
  time frame: 10 weeks
  description: Qualitative data from semi-structured interviews
  measure: Experiences and perspectives of rehabilitation professionals regarding the intervention and study procedures
  time frame: 10 weeks
  description: Qualitative data from focus groups
  measure: Exercise capacity
  time frame: 10 weeks
  description: Incremental cycle ergometry test
  measure: Physical activity behaviour
  time frame: 10 weeks
  description: Moderate to vigorous physical activity (MVPA)
  measure: Weight
  time frame: 10 weeks
  description: Weight in kg
  measure: Blood pressure
  time frame: 10 weeks
  description: Blood pressure in mmHg
  measure: Blood cholesterol
  time frame: 10 weeks
  description: Total cholesterol, HDL-cholesterol, non-HDL-cholesterol, total cholesterol / HDL-cholesterol ratio
  measure: HbA1c
  time frame: 10 weeks
  description: HbA1c level
  measure: Smoking
  time frame: 10 weeks
  description: Number and type of smoking products per week (qualitative data)
  measure: Health-related quality of life
  time frame: 10 weeks
  description: EQ-5D-5L Questionnaire
  measure: Exercise self-efficacy
  time frame: 10 weeks
  description: Exercise Self-Efficacy Scale (ESES)
  measure: Patient safety
  time frame: 10 weeks
  description: Adverse events reporting (number and severity of adverse events) assessed by the Medical Device Coordination Group (MDCG) form
  arm group label: Intervention
  arm group type: Experimental
  arm group label: Control
  arm group type: Other
  intervention type: Other
  intervention name: aktivplan
  description: The aktivplan digital intervention consists of a digital planning calendar for regular heart-healthy physical activity Towards the end of rehabilitation phase II, health professionals introduce aktivplan and plan a personalised physical activity plan together with their patients using shared decision-making. The physical activity plan is devised for the time after discharge from cardiac rehabilitation.
  In the aktivplan smatphone app, the patient can view their personalised physical activity plan, check off completed activities, enter additional unplanned activities, and open short videos with exercise instructions.
  Additional functions of aktivplan include patient-centered goal-setting, automated messages to the patient (motivational messages and reminders), and the possibility for health professionals to monitor all their patients' adherence to the physical activity plan and to contact individual patients directly via the app.
  arm group label: Intervention
  intervention type: Other
  intervention name: Usual care
  description: Usual care (standard of care) according to international and national cardiac rehabilitation guidelines.
  arm group label: Control
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Stefan T Kulnik, PhD MRes
  role: Study Chair
  affiliation: Ludwig Boltzmann Institute for Digital Health and Prevention
  last name: Stefan T Kulnik, PhD MRes
  phone: 004357255
  phone ext: 82712
  email: tino.kulnik@dhp.lbg.ac.at
  last name: Franziska Pfannerstill, PhD MSc
  phone: 004357255
  phone ext: 82701
  email: franziska.pfannerstill@dhp.lbg.ac.at
  responsible party type: Sponsor
  mesh term: Cardiovascular Diseases
  sharing ipd: No