<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/NCT03813667</url>
  </required_header>
  <id_info>
    <org_study_id>1703528067</org_study_id>
    <nct_id>NCT03813667</nct_id>
  </id_info>
  <brief_title>Palliative Care Coaching for Families With Rare Advanced Lung Diseases</brief_title>
  <official_title>Palliative Care Coaching for Family Caregivers &amp; Patients With Rare Advanced Lung Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>West Virginia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>West Virginia University</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>
      With one of the highest incidences of lung disease deaths in the nation, there is great need&#xD;
      for home end-of-life palliative care in the rural, disadvantaged communities of West&#xD;
      Virginia. The aims of this proposed study are to: (1) pilot test the nursing care&#xD;
      intervention with patients and family members managing home supportive EOLPC for rare&#xD;
      advanced lung disease and (2) collect research data to report in the NIH resubmission and&#xD;
      future trials.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Nearly 15 million Americans and greater than 10% of West Virginia (WV) residents live with&#xD;
      and eventually die from Rare and Advanced Lung Diseases (R-ALD), including pneumoconiosis&#xD;
      (i.e., dust, asbestos), and idiopathic pulmonary fibrosis. Patients with R-ALD experience&#xD;
      refractory breathlessness, depression, fatigue, and extreme worry about their family members&#xD;
      and cost of health care. With one of the highest incidences of lung disease deaths in the&#xD;
      nation, there is great need for home EOLPC in the rural, disadvantaged communities of WV. The&#xD;
      proposed EOLPC intervention (FamPALcare) is based on R-ALD experts' input, national EOLPC&#xD;
      guidelines, and the PI's published EOLPC studies with breathlessness in end-stage heart&#xD;
      failure (HF) patients.&#xD;
&#xD;
      This project is well-aligned with the National Institutes of Health (NIH) priority specific&#xD;
      to &quot;Appalachian populations experiencing extreme inequities and poor access to healthcare&quot;&#xD;
      and the NIH PAR on palliative care for family caregivers and patients with advanced lung&#xD;
      diseases. The PI's NIH application review, which received a positive score, stated that this&#xD;
      project will have a high impact on improving palliative care for rural families managing lung&#xD;
      disease and the project can be translated to other rural communities. This is an initial&#xD;
      study of coaching home-based palliative R-ALD care in rural Appalachia. The NIH review stated&#xD;
      using the PI's culturally sensitive approaches for R-ALD was novel for chronic lung disease.&#xD;
      Also, addressing both family caregivers' and patients' needs was noted as innovative and&#xD;
      increased the potential for future funding, as was the rigorous protocol for observing&#xD;
      intervention fidelity.&#xD;
&#xD;
      This study uses a random control group comparison design to test the implementation of the&#xD;
      FamPALcare intervention with R-ALD patients and their primary family caregiver. Specific aims&#xD;
      are to: (1) pilot test the FamPALcare nursing care intervention with patients and family&#xD;
      members managing home supportive EOLPC for R-ALD and (2) collect research data to report in&#xD;
      the PI's NIH resubmission and future trials. The control patients receive standard care given&#xD;
      through the WVU hospital and outpatient clinics, prescribed by the patient's pulmonologist,&#xD;
      and recorded in the medical record. The FamPALcare intervention group receives all standard&#xD;
      care plus 2 weeks of home EOLPC coaching by community nurses experienced in EOLPC. Data will&#xD;
      be collected at baseline, month one, and month three from patients and caregivers&#xD;
      independently. This pilot study provides testing of our research guides and procedures that&#xD;
      will be described to enhance the NIH resubmission and will determine power needed for the&#xD;
      future RCT design.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2018</start_date>
  <completion_date type="Actual">September 30, 2019</completion_date>
  <primary_completion_date type="Actual">September 30, 2019</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>This study uses a random control group comparison design to test the implementation of the FamPALcare intervention with R-ALD patients and their primary family caregivers.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Double (Care Provider, Outcomes Assessor)</masking>
    <masking_description>Care provider and outcome assessor including data collectors will be blinded to group assignment.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>patient outcomes</measure>
    <time_frame>3 months</time_frame>
    <description>The intervention group R-ALD patients will report lower scores on breathlessness scale compared to control group patients at 3 months.&#xD;
Breathlessness is measured by Self-report shortness of breath scale (1 item, 0-10; 0-no shortness of breath, 10 = shortness of breath as bad as can be) (Gift, Narsavage, 1998</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>family caregiver outcomes</measure>
    <time_frame>3 months</time_frame>
    <description>The intervention group family caregivers will rate lower scores on Anxiety and Depression on PHQ-4 Scale compared to control group caregivers at 3 months.&#xD;
Anxiety and Depression are measured by PHQ-4 Scale, 4-item Likert scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>patients' decision on EOLPC</measure>
    <time_frame>3 months</time_frame>
    <description>The intervention group will report higher numbers of signed advance directives.&#xD;
This outcome is measured by the presence of signed advance directives in the medical record. Various types of advance directives will be identified.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Helpfulness of home R-ALD EOLPC intervention</measure>
    <time_frame>3 months</time_frame>
    <description>Each patient and family member will rate the 11-item Likert Intervention on the Helpfulness scale at 3 months. Range 1-5, 1= strongly disagree/not helpful and 5 = strong agree/helpful.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">35</enrollment>
  <condition>Lung Diseases</condition>
  <condition>Rare Non-Neoplastic Disorder</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The control patients have standard care given through the WVU hospital and outpatient clinics, prescribed by the patient's pulmonologist and recorded in the medical record</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The FamPALcare intervention group receives all standard care plus 2 weeks of home EOLPC coaching by community nurses experienced in end-of-life palliative care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Intervention FamPALcare</intervention_name>
    <description>The FamPALcare intervention includes all standard care information on R-ALD home care plus 2 weeks of EOLPC coaching by community nurses experienced in EOLPC. The nurse uses the &quot;Conversation Ready&quot; pamphlet to guide discussion of EOL preferences. The nurse will: (1) support the patient and family in making decisions about EOL care options based on their preferences; (2) discuss options for EOL care when the patient's R-ALD symptoms become severe; (3) encourage completion of the advance directive forms at next physician appointment. The nurse will use &quot;teach-back&quot; processes to ensure that FamPALcare discussions are clear.</description>
    <arm_group_label>Intervention</arm_group_label>
    <other_name>FamPALcare</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients diagnosed with R-ALD, and their primary family caregivers dyad.&#xD;
&#xD;
          -  All participants must be alert and oriented.&#xD;
&#xD;
          -  Be able to read and write in English.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have received or are on a waiting list for a lung transplant&#xD;
&#xD;
          -  Patients diagnosed with another terminal illness.&#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>Ubolrat Piamjariyakul, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>West Virginia University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>West Virginia University Hospital</name>
      <address>
        <city>Morgantown</city>
        <state>West Virginia</state>
        <zip>26506</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>October 11, 2018</study_first_submitted>
  <study_first_submitted_qc>January 22, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>October 18, 2019</last_update_submitted>
  <last_update_submitted_qc>October 18, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 21, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>West Virginia University</investigator_affiliation>
    <investigator_full_name>Ubolrat Piamjariyakul</investigator_full_name>
    <investigator_title>Associate Dean of Research</investigator_title>
  </responsible_party>
  <keyword>advanced lung diseases</keyword>
  <keyword>Palliative Care</keyword>
  <keyword>Dyspnea</keyword>
  <keyword>pilot projects</keyword>
  <keyword>Terminal Care</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>This is a pilot RCT, the researchers do not want to share the IPD.</ipd_description>
  </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/NCT03813667
org study id: 1703528067
nct id: NCT03813667
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
With one of the highest incidences of lung disease deaths in the nation, there is great need
      for home end-of-life palliative care in the rural, disadvantaged communities of West
      Virginia. The aims of this proposed study are to: (1) pilot test the nursing care
      intervention with patients and family members managing home supportive EOLPC for rare
      advanced lung disease and (2) collect research data to report in the NIH resubmission and
      future trials.
Nearly 15 million Americans and greater than 10% of West Virginia (WV) residents live with
      and eventually die from Rare and Advanced Lung Diseases (R-ALD), including pneumoconiosis
      (i.e., dust, asbestos), and idiopathic pulmonary fibrosis. Patients with R-ALD experience
      refractory breathlessness, depression, fatigue, and extreme worry about their family members
      and cost of health care. With one of the highest incidences of lung disease deaths in the
      nation, there is great need for home EOLPC in the rural, disadvantaged communities of WV. The
      proposed EOLPC intervention (FamPALcare) is based on R-ALD experts' input, national EOLPC
      guidelines, and the PI's published EOLPC studies with breathlessness in end-stage heart
      failure (HF) patients.

      This project is well-aligned with the National Institutes of Health (NIH) priority specific
      to "Appalachian populations experiencing extreme inequities and poor access to healthcare"
      and the NIH PAR on palliative care for family caregivers and patients with advanced lung
      diseases. The PI's NIH application review, which received a positive score, stated that this
      project will have a high impact on improving palliative care for rural families managing lung
      disease and the project can be translated to other rural communities. This is an initial
      study of coaching home-based palliative R-ALD care in rural Appalachia. The NIH review stated
      using the PI's culturally sensitive approaches for R-ALD was novel for chronic lung disease.
      Also, addressing both family caregivers' and patients' needs was noted as innovative and
      increased the potential for future funding, as was the rigorous protocol for observing
      intervention fidelity.

      This study uses a random control group comparison design to test the implementation of the
      FamPALcare intervention with R-ALD patients and their primary family caregiver. Specific aims
      are to: (1) pilot test the FamPALcare nursing care intervention with patients and family
      members managing home supportive EOLPC for R-ALD and (2) collect research data to report in
      the PI's NIH resubmission and future trials. The control patients receive standard care given
      through the WVU hospital and outpatient clinics, prescribed by the patient's pulmonologist,
      and recorded in the medical record. The FamPALcare intervention group receives all standard
      care plus 2 weeks of home EOLPC coaching by community nurses experienced in EOLPC. Data will
      be collected at baseline, month one, and month three from patients and caregivers
      independently. This pilot study provides testing of our research guides and procedures that
      will be described to enhance the NIH resubmission and will determine power needed for the
      future RCT design.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This study uses a random control group comparison design to test the implementation of the FamPALcare intervention with R-ALD patients and their primary family caregivers.
primary purpose: Supportive Care
masking: Double (Care Provider, Outcomes Assessor)
masking description: Care provider and outcome assessor including data collectors will be blinded to group assignment.
measure: patient outcomes
time frame: 3 months
description: The intervention group R-ALD patients will report lower scores on breathlessness scale compared to control group patients at 3 months.
Breathlessness is measured by Self-report shortness of breath scale (1 item, 0-10; 0-no shortness of breath, 10 = shortness of breath as bad as can be) (Gift, Narsavage, 1998
measure: family caregiver outcomes
time frame: 3 months
description: The intervention group family caregivers will rate lower scores on Anxiety and Depression on PHQ-4 Scale compared to control group caregivers at 3 months.
Anxiety and Depression are measured by PHQ-4 Scale, 4-item Likert scale.
measure: patients' decision on EOLPC
time frame: 3 months
description: The intervention group will report higher numbers of signed advance directives.
This outcome is measured by the presence of signed advance directives in the medical record. Various types of advance directives will be identified.
measure: Helpfulness of home R-ALD EOLPC intervention
time frame: 3 months
description: Each patient and family member will rate the 11-item Likert Intervention on the Helpfulness scale at 3 months. Range 1-5, 1= strongly disagree/not helpful and 5 = strong agree/helpful.
arm group label: Control
arm group type: No Intervention
description: The control patients have standard care given through the WVU hospital and outpatient clinics, prescribed by the patient's pulmonologist and recorded in the medical record
arm group label: Intervention
arm group type: Experimental
description: The FamPALcare intervention group receives all standard care plus 2 weeks of home EOLPC coaching by community nurses experienced in end-of-life palliative care.
intervention type: Behavioral
intervention name: Intervention FamPALcare
description: The FamPALcare intervention includes all standard care information on R-ALD home care plus 2 weeks of EOLPC coaching by community nurses experienced in EOLPC. The nurse uses the "Conversation Ready" pamphlet to guide discussion of EOL preferences. The nurse will: (1) support the patient and family in making decisions about EOL care options based on their preferences; (2) discuss options for EOL care when the patient's R-ALD symptoms become severe; (3) encourage completion of the advance directive forms at next physician appointment. The nurse will use "teach-back" processes to ensure that FamPALcare discussions are clear.
arm group label: Intervention
other name: FamPALcare
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ubolrat Piamjariyakul, PhD
role: Principal Investigator
affiliation: West Virginia University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: West Virginia University
investigator full name: Ubolrat Piamjariyakul
investigator title: Associate Dean of Research
mesh term: Lung Diseases
sharing ipd: No
ipd description: This is a pilot RCT, the researchers do not want to share the IPD.