<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/NCT04490148</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00006924part2</org_study_id>
    <nct_id>NCT04490148</nct_id>
  </id_info>
  <brief_title>Remote Pulmonary Function Testing and Nurse Coaching in ALS</brief_title>
  <official_title>Remote Pulmonary Function Testing and Nurse Respiratory Health Coaching in Amyotrophic Lateral Sclerosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Milton S. Hershey Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>ALS Association</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Milton S. Hershey Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Comparison of respiratory outcomes in patients receiving telemedicine-guided remote pulmonary&#xD;
      function testing (rPFT) with or without the additional support of nurse coaching. This is a&#xD;
      randomized controlled study which assesses the effects rPFT and coaching on respiratory&#xD;
      outcomes and quality of life.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a two-arm, randomized study to determine 1) whether weekly monitoring of respiratory&#xD;
      function can lead to timelier initiation of NIV and 2) whether structured nurse coaching&#xD;
      leads to improved self-efficacy for managing disease and better maintenance of respiratory&#xD;
      health. For enrollees in both arms, standard FVC and MIP measurements obtained approximately&#xD;
      every three months by the respiratory therapist during ALS Clinic are supplemented with&#xD;
      self-administered rPFTs performed weekly. Enrollees in the rPFT+NRHC (nurse respiratory&#xD;
      health coaching) arm will additionally receive monthly coaching with the study nurse via&#xD;
      telehealth. Outcomes include measures of quality of life and self-efficacy for managing&#xD;
      disease.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Anticipated">June 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</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 longitudinal parallel group study of repeated measures of remote PFTs, nurse coaching, and their impact on respiratory outcomes.</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Date of identification of noninvasive ventilation (NIV) need from rPFT monitoring</measure>
    <time_frame>1 year</time_frame>
    <description>Date of identification of NIV need from rPFT monitoring</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Date of identification of NIV need from standard PFT monitoring</measure>
    <time_frame>1 year</time_frame>
    <description>Date of identification of NIV need from standard PFT monitoring</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Self-efficacy</measure>
    <time_frame>1 year</time_frame>
    <description>The self-efﬁcacy assessment contains questions from the PROMIS item banks on Self-Efﬁcacy for Managing Symptoms (9 items), Self-Efficacy for Managing Social Interactions (5 items), and Self-Efficacy for Managing Medications and Treatments (4 items). These assessment tools, designed for use in chronic conditions, are scored as an average of individual components on a 1-5 scale.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Respiratory-related quality of life</measure>
    <time_frame>1 year</time_frame>
    <description>The respiratory questionnaire contains three Patient-Reported Outcomes Measurement Information System (PROMIS) sub-scales on Dyspnea Characteristics (5 items), Dyspnea Functional Limitations (10 items), and Sleep Related Impairment (8 items). The PROMIS sub-scales, all of which utilize Likert-type scaling, will be summed as composite scores, with higher numbers indicating poorer quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Respiratory-related medical complications</measure>
    <time_frame>1 year</time_frame>
    <description>Also included in the respiratory questionnaire are seven questions regarding respiratory complications experienced in the previous month.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>rPFT Adherence</measure>
    <time_frame>1 year</time_frame>
    <description>Participant adherence to rPFT protocol, defined as the percentage of eligible weeks with a submitted rPFT report.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>ALS</condition>
  <arm_group>
    <arm_group_label>remote PFT (rPFT) longitudinal</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects will undergo standard pulmonary function testing as part of standard clinical procedure. They will also undergo weekly remote pulmonary function testing using the telemedicine interface and study equipment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>remote PFT (rPFT) + Nurse Coaching longitudinal</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will undergo standard pulmonary function testing as part of standard clinical procedure. They will also undergo weekly remote pulmonary function testing using the telemedicine interface and study equipment, and receive monthly coaching from an ALS nurse.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>remote pulmonary function testing</intervention_name>
    <description>Telemedicine delivery of pulmonary function testing in ALS, including Forced Vital Capacity (FVC) and Maximal Inspiratory Pressure (MIP)</description>
    <arm_group_label>remote PFT (rPFT) + Nurse Coaching longitudinal</arm_group_label>
    <arm_group_label>remote PFT (rPFT) longitudinal</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>standard pulmonary function testing</intervention_name>
    <description>Standard clinical delivery of pulmonary function testing in ALS, including Forced Vital Capacity (FVC) and Maximal Inspiratory Pressure (MIP)</description>
    <arm_group_label>remote PFT (rPFT) + Nurse Coaching longitudinal</arm_group_label>
    <arm_group_label>remote PFT (rPFT) longitudinal</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Nurse Respiratory Health Coaching (NRHC)</intervention_name>
    <description>Nurse Respiratory Health Coaching - The NRHC intervention follows the &quot;teamlet&quot; model described by Bennett et al. [Bennett2010], made up of the research coordinator who performs respiratory testing, and the nurse practitioner who coaches using the GROW (goals, realities, options, wrap-up) model.</description>
    <arm_group_label>remote PFT (rPFT) + Nurse Coaching longitudinal</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients:&#xD;
&#xD;
          1. Possess a diagnosis of definite, probable, probable laboratory-supported, or possible&#xD;
             ALS by revised El Escorial research criteria [Brooks2000].&#xD;
&#xD;
          2. Be 18 years of age or older.&#xD;
&#xD;
          3. Have a caregiver available to participate in the study&#xD;
&#xD;
          4. Symptom onset within the last three years.&#xD;
&#xD;
          5. Have a computer and home internet service sufficient for engaging in telemedicine&#xD;
             sessions.&#xD;
&#xD;
          6. Have a second device capable of downloading the spirometer application from an app&#xD;
             store (Android- or iOS-based smartphone or tablet).&#xD;
&#xD;
        Caregivers:&#xD;
&#xD;
          1. Be 18 years of age or older, of either gender.&#xD;
&#xD;
          2. Be able and willing to provide informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients:&#xD;
&#xD;
          1. Use of NIV or diaphragm pacer at time of obtaining informed consent.&#xD;
&#xD;
          2. FVC ≤50% predicted or MIP &gt; -60 cm of water.&#xD;
&#xD;
          3. ALS Functional Rating Scale (ALSFRS-R) [Cedarbaum1999] score on day of screening of ≥2&#xD;
             on items for speech, swallowing, and salivation. These items are indicators of bulbar&#xD;
             dysfunction, which limits the reliability of PFT administration.&#xD;
&#xD;
          4. Cognitive impairment, as judged by the ALS clinic neurologist, that prevents&#xD;
             participation in the study.&#xD;
&#xD;
        Caregivers: None&#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_contact>
    <last_name>Andrew Geronimo, PhD</last_name>
    <phone>717-531-0003</phone>
    <phone_ext>282576</phone_ext>
    <email>geronimo@psu.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Abid Kazi, PhD</last_name>
    <phone>717-531-0003</phone>
    <phone_ext>282465</phone_ext>
    <email>akazi@pennstatehealth.psu.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hershey Medical Center ALS Clinic</name>
      <address>
        <city>Hershey</city>
        <state>Pennsylvania</state>
        <zip>17033</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andrew Geronimo, PhD</last_name>
      <phone>717-531-0003</phone>
      <phone_ext>282576</phone_ext>
      <email>ageronimo@pennstatehealth.psu.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>July 22, 2020</study_first_submitted>
  <study_first_submitted_qc>July 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2020</study_first_posted>
  <last_update_submitted>March 22, 2023</last_update_submitted>
  <last_update_submitted_qc>March 22, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 23, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Milton S. Hershey Medical Center</investigator_affiliation>
    <investigator_full_name>Zachary Simmons, MD</investigator_full_name>
    <investigator_title>Professor of Neurology and Humanities</investigator_title>
  </responsible_party>
  <keyword>Telemedicine</keyword>
  <keyword>Pulmonary Function Testing</keyword>
  <keyword>Telehealth</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No plan at this time to share data with other researchers</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/NCT04490148
org study id: STUDY00006924part2
nct id: NCT04490148
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
Comparison of respiratory outcomes in patients receiving telemedicine-guided remote pulmonary
      function testing (rPFT) with or without the additional support of nurse coaching. This is a
      randomized controlled study which assesses the effects rPFT and coaching on respiratory
      outcomes and quality of life.
This is a two-arm, randomized study to determine 1) whether weekly monitoring of respiratory
      function can lead to timelier initiation of NIV and 2) whether structured nurse coaching
      leads to improved self-efficacy for managing disease and better maintenance of respiratory
      health. For enrollees in both arms, standard FVC and MIP measurements obtained approximately
      every three months by the respiratory therapist during ALS Clinic are supplemented with
      self-administered rPFTs performed weekly. Enrollees in the rPFT+NRHC (nurse respiratory
      health coaching) arm will additionally receive monthly coaching with the study nurse via
      telehealth. Outcomes include measures of quality of life and self-efficacy for managing
      disease.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: A longitudinal parallel group study of repeated measures of remote PFTs, nurse coaching, and their impact on respiratory outcomes.
primary purpose: Health Services Research
masking: None (Open Label)
measure: Date of identification of noninvasive ventilation (NIV) need from rPFT monitoring
time frame: 1 year
description: Date of identification of NIV need from rPFT monitoring
measure: Date of identification of NIV need from standard PFT monitoring
time frame: 1 year
description: Date of identification of NIV need from standard PFT monitoring
measure: Self-efficacy
time frame: 1 year
description: The self-efﬁcacy assessment contains questions from the PROMIS item banks on Self-Efﬁcacy for Managing Symptoms (9 items), Self-Efficacy for Managing Social Interactions (5 items), and Self-Efficacy for Managing Medications and Treatments (4 items). These assessment tools, designed for use in chronic conditions, are scored as an average of individual components on a 1-5 scale.
measure: Respiratory-related quality of life
time frame: 1 year
description: The respiratory questionnaire contains three Patient-Reported Outcomes Measurement Information System (PROMIS) sub-scales on Dyspnea Characteristics (5 items), Dyspnea Functional Limitations (10 items), and Sleep Related Impairment (8 items). The PROMIS sub-scales, all of which utilize Likert-type scaling, will be summed as composite scores, with higher numbers indicating poorer quality of life.
measure: Respiratory-related medical complications
time frame: 1 year
description: Also included in the respiratory questionnaire are seven questions regarding respiratory complications experienced in the previous month.
measure: rPFT Adherence
time frame: 1 year
description: Participant adherence to rPFT protocol, defined as the percentage of eligible weeks with a submitted rPFT report.
arm group label: remote PFT (rPFT) longitudinal
arm group type: Active Comparator
description: Subjects will undergo standard pulmonary function testing as part of standard clinical procedure. They will also undergo weekly remote pulmonary function testing using the telemedicine interface and study equipment.
arm group label: remote PFT (rPFT) + Nurse Coaching longitudinal
arm group type: Experimental
description: Subjects will undergo standard pulmonary function testing as part of standard clinical procedure. They will also undergo weekly remote pulmonary function testing using the telemedicine interface and study equipment, and receive monthly coaching from an ALS nurse.
intervention type: Device
intervention name: remote pulmonary function testing
description: Telemedicine delivery of pulmonary function testing in ALS, including Forced Vital Capacity (FVC) and Maximal Inspiratory Pressure (MIP)
arm group label: remote PFT (rPFT) + Nurse Coaching longitudinal
arm group label: remote PFT (rPFT) longitudinal
intervention type: Device
intervention name: standard pulmonary function testing
description: Standard clinical delivery of pulmonary function testing in ALS, including Forced Vital Capacity (FVC) and Maximal Inspiratory Pressure (MIP)
arm group label: remote PFT (rPFT) + Nurse Coaching longitudinal
arm group label: remote PFT (rPFT) longitudinal
intervention type: Behavioral
intervention name: Nurse Respiratory Health Coaching (NRHC)
description: Nurse Respiratory Health Coaching - The NRHC intervention follows the "teamlet" model described by Bennett et al. [Bennett2010], made up of the research coordinator who performs respiratory testing, and the nurse practitioner who coaches using the GROW (goals, realities, options, wrap-up) model.
arm group label: remote PFT (rPFT) + Nurse Coaching longitudinal
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Andrew Geronimo, PhD
phone: 717-531-0003
phone ext: 282576
email: geronimo@psu.edu
last name: Abid Kazi, PhD
phone: 717-531-0003
phone ext: 282465
email: akazi@pennstatehealth.psu.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Milton S. Hershey Medical Center
investigator full name: Zachary Simmons, MD
investigator title: Professor of Neurology and Humanities
sharing ipd: No
ipd description: No plan at this time to share data with other researchers