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/NCT06008210</url>
    </required_header>
    <id_info>
      <org_study_id>14118622</org_study_id>
      <nct_id>NCT06008210</nct_id>
    </id_info>
    <brief_title>A Decision Aid on End-of-life Care for Patients With Advanced COPD and Their Family</brief_title>
    <official_title>Effects of a Decision Support Intervention on End-of-life Care Planning in Patients With Advanced Chronic Obstructive Pulmonary Disease and Their Family Members: A Mixed Method Approach</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Food and Health Bureau, Hong Kong</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Hospital Authority, Hong Kong</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Food and Health Bureau, Hong Kong</source>
    <oversight_info>
      <has_dmc>Yes</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 study aims to support EOL decision-making in patients with advanced COPD and their&#xD;
        family members. A parallel two-arm single-blinded randomised controlled trial will be&#xD;
        conducted to evaluate the effects of a specific decision support intervention. A total of 226&#xD;
        patients with advanced COPD and their designated family members will be recruited from&#xD;
        hospital wards and outpatient clinics.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Chronic Obstructive Pulmonary Disease (COPD) is a progressive life-limiting condition.&#xD;
        However, patients with advanced COPD and their family members generally are unprepared for&#xD;
        end-of-life (EOL) situations. The Ottawa Decision Support Framework model is adopted to&#xD;
        address the patients' decisional needs for the difficult decisions in EOL care. The&#xD;
        participants will be randomly allocated to either the intervention group to receive the&#xD;
        decision support intervention or the control group to receive general health coaching.&#xD;
        Outcomes will be measured at baseline and 1- and 6-month post-allocation. Subsequently, a&#xD;
        descriptive qualitative study will be conducted with a subsample of 30 dyads to explore how&#xD;
        the intervention influenced the study outcomes.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 1, 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>
      <intervention_model_description>A parallel two-arm single-blinded randomised controlled trial will be conducted.</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Decisional conflict at T0</measure>
      <time_frame>Baseline</time_frame>
      <description>Decisional conflict regarding EOL care measured using The SURE test. It includes four items to be rated on a dichotomous format, with 0 (no) or 1 (yes). The total score ranged from 0 to 4, with a higher score means less decisional conflict.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Decisional conflict at T1</measure>
      <time_frame>1-month post allocation</time_frame>
      <description>Decisional conflict regarding EOL care measured using The SURE test. It includes four items to be rated on a dichotomous format, with 0 (no) or 1 (yes). The total score ranged from 0 to 4, with a higher score means less decisional conflict.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Decisional conflict at T2</measure>
      <time_frame>6-month post allocation</time_frame>
      <description>Decisional conflict regarding EOL care measured using The SURE test. It includes four items to be rated on a dichotomous format, with 0 (no) or 1 (yes). The total score ranged from 0 to 4, with a higher score means less decisional conflict.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Self-efficacy for ACP at T0</measure>
      <time_frame>Baseline</time_frame>
      <description>Self-efficacy for ACP measured using the 3-item Self-efficacy subscale of the ACP Engagement Survey. Participants will rate their level of self-efficacy regarding three ACP actions - namely, appointing a surrogate and discussing EOL care with a surrogate and with medical doctors - using a five-point Likert scale. A higher score indicates a higher level of self-efficacy.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Self-efficacy for ACP at T1</measure>
      <time_frame>1-month post allocation</time_frame>
      <description>Self-efficacy for ACP measured using the 3-item Self-efficacy subscale of the ACP Engagement Survey. Participants will rate their level of self-efficacy regarding three ACP actions - namely, appointing a surrogate and discussing EOL care with a surrogate and with medical doctors - using a five-point Likert scale. A higher score indicates a higher level of self-efficacy.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Self-efficacy for ACP at T2</measure>
      <time_frame>6-month post allocation</time_frame>
      <description>Self-efficacy for ACP measured using the 3-item Self-efficacy subscale of the ACP Engagement Survey. Participants will rate their level of self-efficacy regarding three ACP actions - namely, appointing a surrogate and discussing EOL care with a surrogate and with medical doctors - using a five-point Likert scale. A higher score indicates a higher level of self-efficacy.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Readiness for ACP at T0</measure>
      <time_frame>Baseline</time_frame>
      <description>Readiness for completing the aforementioned three ACP actions based on the ACP Engagement Survey. Participants will rate their readiness using a five-point scale, from 1 (never thought about it) to 5 (completed already). The total score ranged from 4 to 20. A higher score indicates a higher level of readiness.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Readiness for ACP at T1</measure>
      <time_frame>1-month post allocation</time_frame>
      <description>Readiness for completing the aforementioned three ACP actions based on the ACP Engagement Survey. Participants will rate their readiness using a five-point scale, from 1 (never thought about it) to 5 (completed already). The total score ranged from 4 to 20. A higher score indicates a higher level of readiness.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Readiness for ACP at T2</measure>
      <time_frame>6-month post allocation</time_frame>
      <description>Readiness for completing the aforementioned three ACP actions based on the ACP Engagement Survey. Participants will rate their readiness using a five-point scale, from 1 (never thought about it) to 5 (completed already). The total score ranged from 4 to 20. A higher score indicates a higher level of readiness.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Family members' engagement in ACP at T0</measure>
      <time_frame>Baseline</time_frame>
      <description>Family members' engagement in ACP will be measured by using the 17-item ACP Engagement Survey for Surrogate Decision Makers. Participants will rate their level of engagement using a five-point scale, from 1 (least) to 5 (highest). The total score ranged from 17 to 85. A higher score indicates a higher level of engagement.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Family members' engagement in ACP at T1</measure>
      <time_frame>1-month post allocation</time_frame>
      <description>Family members' engagement in ACP will be measured by using the 17-item ACP Engagement Survey for Surrogate Decision Makers. Participants will rate their level of engagement using a five-point scale, from 1 (least) to 5 (highest). The total score ranged from 17 to 85. A higher score indicates a higher level of engagement.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Family members' engagement in ACP at T2</measure>
      <time_frame>6-month post allocation</time_frame>
      <description>Family members' engagement in ACP will be measured by using the 17-item ACP Engagement Survey for Surrogate Decision Makers. Participants will rate their level of engagement using a five-point scale, from 1 (least) to 5 (highest). The total score ranged from 17 to 85. A higher score indicates a higher level of engagement.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>End-of-life care preferences at T1</measure>
      <time_frame>1-month post allocation</time_frame>
      <description>End-of-life care preferences will be determined using the adapted Life-Support Preferences Questionnaire. Participants will be asked to indicate whether they would accept cardiopulmonary resuscitation, mechanical ventilator and tube feeding if they become seriously ill and mentally incapacitated. There are three options: yes, no and uncertain. In addition, they will be asked to indicate their preferred goal of end-of-life care. The available options are maintain life at all costs, maintain comfort and uncertain. There is no scoring for the responses.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>End-of-life care preferences at T2</measure>
      <time_frame>6-month post allocation</time_frame>
      <description>End-of-life care preferences will be determined using the adapted Life-Support Preferences Questionnaire. Participants will be asked to indicate whether they would accept cardiopulmonary resuscitation, mechanical ventilator and tube feeding if they become seriously ill and mentally incapacitated. There are three options: yes, no and uncertain. In addition, they will be asked to indicate their preferred goal of end-of-life care. The available options are maintain life at all costs, maintain comfort and uncertain. There is no scoring for the responses.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Advance directives at T2</measure>
      <time_frame>6-month post allocation</time_frame>
      <description>Participants will be asked if they have completed advance directives in the past six months.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">226</enrollment>
    <condition>Chronic Obstructive Pulmonary Disease Severe</condition>
    <arm_group>
      <arm_group_label>Intervention Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Decision Support Intervention</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Health coaching</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Decision Support Intervention</intervention_name>
      <description>The participants will receive two 60-minute consultation sessions delivered by a trained nurse in four weeks at home. Participant's family members will be encouraged to attend the sessions. In the first session, the nurse will explore the participant's understanding of the current health condition, introduce the concept of advance care planning and discuss their decisional needs for end-of-life care decision-making. In the second session, the nurse will ask the participants to complete a value clarification exercise individually.</description>
      <arm_group_label>Intervention Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Health Coaching</intervention_name>
      <description>The participants will receive two 60-minute health coaching sessions delivered by a trained nurse in four weeks at home. This intervention will focus on lifestyle modification and self-care management unrelated to the tested intervention content or outcomes.</description>
      <arm_group_label>Control Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria of patients:&#xD;
  &#xD;
            -  are aged 50 years or over&#xD;
  &#xD;
            -  have been diagnosed with COPD&#xD;
  &#xD;
            -  are cognitively sound (scored &gt; 5 on the validated Abbreviated Mental Test (Hong Kong&#xD;
               version) [AMT-HK])&#xD;
  &#xD;
            -  meet at least two of the six specific clinical indicators related to advanced COPD in&#xD;
               the Gold Standards Framework (GSF) Proactive Identification Guidance, 6th Edition&#xD;
  &#xD;
            -  can nominate a family member who would take part in their healthcare decision- making.&#xD;
  &#xD;
          Inclusion Criteria of patients' family members:&#xD;
  &#xD;
            -  are aged 18 years or over,&#xD;
  &#xD;
            -  can communicate in Cantonese,&#xD;
  &#xD;
            -  have at least one personal contact per week with the patient in the past 6 months and&#xD;
  &#xD;
            -  are willing to join the study. Family members will be excluded if they score &lt; 6 on&#xD;
               the AMT-HK or are expecting to leave Hong Kong within the next 6 months.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  non-communicable due to a severe hearing impairment, dysphasia or a language barrier;&#xD;
  &#xD;
            -  are receiving palliative care services or&#xD;
  &#xD;
            -  have already completed ACP or an advance directive.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>50 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Helen Chan, Ph.D.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Chinese University of Hong Kong</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Helen Chan, Ph.D.</last_name>
      <phone>39438099</phone>
      <email>helencyl@cuhk.edu.hk</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 18, 2023</study_first_submitted>
    <study_first_submitted_qc>August 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 25, 2023</last_update_submitted>
    <last_update_submitted_qc>August 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Chinese University of Hong Kong</investigator_affiliation>
      <investigator_full_name>Helen YL Chan</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>Advance Care Planning</keyword>
    <keyword>Decision making</keyword>
    <keyword>End-of-life care</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Lung Diseases</mesh_term>
      <mesh_term>Lung Diseases, Obstructive</mesh_term>
      <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
      <mesh_term>Death</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Data will be shared upon request</ipd_description>
    </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/NCT06008210
  org study id: 14118622
  nct id: NCT06008210
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This study aims to support EOL decision-making in patients with advanced COPD and their
        family members. A parallel two-arm single-blinded randomised controlled trial will be
        conducted to evaluate the effects of a specific decision support intervention. A total of 226
        patients with advanced COPD and their designated family members will be recruited from
        hospital wards and outpatient clinics.
  Chronic Obstructive Pulmonary Disease (COPD) is a progressive life-limiting condition.
        However, patients with advanced COPD and their family members generally are unprepared for
        end-of-life (EOL) situations. The Ottawa Decision Support Framework model is adopted to
        address the patients' decisional needs for the difficult decisions in EOL care. The
        participants will be randomly allocated to either the intervention group to receive the
        decision support intervention or the control group to receive general health coaching.
        Outcomes will be measured at baseline and 1- and 6-month post-allocation. Subsequently, a
        descriptive qualitative study will be conducted with a subsample of 30 dyads to explore how
        the intervention influenced the study outcomes.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: A parallel two-arm single-blinded randomised controlled trial will be conducted.
  primary purpose: Supportive Care
  masking: Single (Outcomes Assessor)
  measure: Decisional conflict at T0
  time frame: Baseline
  description: Decisional conflict regarding EOL care measured using The SURE test. It includes four items to be rated on a dichotomous format, with 0 (no) or 1 (yes). The total score ranged from 0 to 4, with a higher score means less decisional conflict.
  measure: Decisional conflict at T1
  time frame: 1-month post allocation
  description: Decisional conflict regarding EOL care measured using The SURE test. It includes four items to be rated on a dichotomous format, with 0 (no) or 1 (yes). The total score ranged from 0 to 4, with a higher score means less decisional conflict.
  measure: Decisional conflict at T2
  time frame: 6-month post allocation
  description: Decisional conflict regarding EOL care measured using The SURE test. It includes four items to be rated on a dichotomous format, with 0 (no) or 1 (yes). The total score ranged from 0 to 4, with a higher score means less decisional conflict.
  measure: Self-efficacy for ACP at T0
  time frame: Baseline
  description: Self-efficacy for ACP measured using the 3-item Self-efficacy subscale of the ACP Engagement Survey. Participants will rate their level of self-efficacy regarding three ACP actions - namely, appointing a surrogate and discussing EOL care with a surrogate and with medical doctors - using a five-point Likert scale. A higher score indicates a higher level of self-efficacy.
  measure: Self-efficacy for ACP at T1
  time frame: 1-month post allocation
  description: Self-efficacy for ACP measured using the 3-item Self-efficacy subscale of the ACP Engagement Survey. Participants will rate their level of self-efficacy regarding three ACP actions - namely, appointing a surrogate and discussing EOL care with a surrogate and with medical doctors - using a five-point Likert scale. A higher score indicates a higher level of self-efficacy.
  measure: Self-efficacy for ACP at T2
  time frame: 6-month post allocation
  description: Self-efficacy for ACP measured using the 3-item Self-efficacy subscale of the ACP Engagement Survey. Participants will rate their level of self-efficacy regarding three ACP actions - namely, appointing a surrogate and discussing EOL care with a surrogate and with medical doctors - using a five-point Likert scale. A higher score indicates a higher level of self-efficacy.
  measure: Readiness for ACP at T0
  time frame: Baseline
  description: Readiness for completing the aforementioned three ACP actions based on the ACP Engagement Survey. Participants will rate their readiness using a five-point scale, from 1 (never thought about it) to 5 (completed already). The total score ranged from 4 to 20. A higher score indicates a higher level of readiness.
  measure: Readiness for ACP at T1
  time frame: 1-month post allocation
  description: Readiness for completing the aforementioned three ACP actions based on the ACP Engagement Survey. Participants will rate their readiness using a five-point scale, from 1 (never thought about it) to 5 (completed already). The total score ranged from 4 to 20. A higher score indicates a higher level of readiness.
  measure: Readiness for ACP at T2
  time frame: 6-month post allocation
  description: Readiness for completing the aforementioned three ACP actions based on the ACP Engagement Survey. Participants will rate their readiness using a five-point scale, from 1 (never thought about it) to 5 (completed already). The total score ranged from 4 to 20. A higher score indicates a higher level of readiness.
  measure: Family members' engagement in ACP at T0
  time frame: Baseline
  description: Family members' engagement in ACP will be measured by using the 17-item ACP Engagement Survey for Surrogate Decision Makers. Participants will rate their level of engagement using a five-point scale, from 1 (least) to 5 (highest). The total score ranged from 17 to 85. A higher score indicates a higher level of engagement.
  measure: Family members' engagement in ACP at T1
  time frame: 1-month post allocation
  description: Family members' engagement in ACP will be measured by using the 17-item ACP Engagement Survey for Surrogate Decision Makers. Participants will rate their level of engagement using a five-point scale, from 1 (least) to 5 (highest). The total score ranged from 17 to 85. A higher score indicates a higher level of engagement.
  measure: Family members' engagement in ACP at T2
  time frame: 6-month post allocation
  description: Family members' engagement in ACP will be measured by using the 17-item ACP Engagement Survey for Surrogate Decision Makers. Participants will rate their level of engagement using a five-point scale, from 1 (least) to 5 (highest). The total score ranged from 17 to 85. A higher score indicates a higher level of engagement.
  measure: End-of-life care preferences at T1
  time frame: 1-month post allocation
  description: End-of-life care preferences will be determined using the adapted Life-Support Preferences Questionnaire. Participants will be asked to indicate whether they would accept cardiopulmonary resuscitation, mechanical ventilator and tube feeding if they become seriously ill and mentally incapacitated. There are three options: yes, no and uncertain. In addition, they will be asked to indicate their preferred goal of end-of-life care. The available options are maintain life at all costs, maintain comfort and uncertain. There is no scoring for the responses.
  measure: End-of-life care preferences at T2
  time frame: 6-month post allocation
  description: End-of-life care preferences will be determined using the adapted Life-Support Preferences Questionnaire. Participants will be asked to indicate whether they would accept cardiopulmonary resuscitation, mechanical ventilator and tube feeding if they become seriously ill and mentally incapacitated. There are three options: yes, no and uncertain. In addition, they will be asked to indicate their preferred goal of end-of-life care. The available options are maintain life at all costs, maintain comfort and uncertain. There is no scoring for the responses.
  measure: Advance directives at T2
  time frame: 6-month post allocation
  description: Participants will be asked if they have completed advance directives in the past six months.
  arm group label: Intervention Group
  arm group type: Experimental
  description: Decision Support Intervention
  arm group label: Control Group
  arm group type: Active Comparator
  description: Health coaching
  intervention type: Behavioral
  intervention name: Decision Support Intervention
  description: The participants will receive two 60-minute consultation sessions delivered by a trained nurse in four weeks at home. Participant's family members will be encouraged to attend the sessions. In the first session, the nurse will explore the participant's understanding of the current health condition, introduce the concept of advance care planning and discuss their decisional needs for end-of-life care decision-making. In the second session, the nurse will ask the participants to complete a value clarification exercise individually.
  arm group label: Intervention Group
  intervention type: Behavioral
  intervention name: Health Coaching
  description: The participants will receive two 60-minute health coaching sessions delivered by a trained nurse in four weeks at home. This intervention will focus on lifestyle modification and self-care management unrelated to the tested intervention content or outcomes.
  arm group label: Control Group
  criteria: 
  gender: All
  minimum age: 50 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Helen Chan, Ph.D.
  role: Principal Investigator
  affiliation: Chinese University of Hong Kong
  last name: Helen Chan, Ph.D.
  phone: 39438099
  email: helencyl@cuhk.edu.hk
  responsible party type: Principal Investigator
  investigator affiliation: Chinese University of Hong Kong
  investigator full name: Helen YL Chan
  investigator title: Professor
  mesh term: Lung Diseases
  mesh term: Lung Diseases, Obstructive
  mesh term: Pulmonary Disease, Chronic Obstructive
  mesh term: Death
  sharing ipd: No
  ipd description: Data will be shared upon request