<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/NCT01670539</url>
  </required_header>
  <id_info>
    <org_study_id>H-22930</org_study_id>
    <secondary_id>1R15CA150999</secondary_id>
    <nct_id>NCT01670539</nct_id>
  </id_info>
  <brief_title>Home Telemonitoring for Patients With Lung Cancer</brief_title>
  <acronym>HTPLC</acronym>
  <official_title>PILOT: Home Telemonitoring for Self-Management Education of Patients With Lung Ca</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>West Virginia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>West Virginia University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to learn more about using a home machine &quot;Telemonitor&quot; to find&#xD;
      problems people with lung cancer may have after being discharged from the hospital and help&#xD;
      them manage problems by contacting their healthcare provider.The study hypothesis is that&#xD;
      patients with lung CA using short-term (14 days)home telemonitors, educated/coached by nurses&#xD;
      on telemonitor data risks/implications for the first two weeks after hospital discharge, will&#xD;
      be able to self-report their signs/ symptoms to the clinician resulting in decreased use of&#xD;
      costly health care resources over 60 days.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All patients in the study will receive usual care after hospital discharge. This study also&#xD;
      involves an interview and review of your medical records, and uses the &quot;telemonitor&quot; machine&#xD;
      to measure your temperature, pulse, oxygen level,weight and blood pressure. The telemonitor&#xD;
      will also ask you to press YES or NO buttons in response to questions on your symptoms such&#xD;
      as difficulty breathing. Research nurses will come to your home 3 times and it will take&#xD;
      about 30 minutes for each visit for the nurse to record the information using the&#xD;
      telemonitor. You will also be asked to fill out a survey about your ability to do activities&#xD;
      and your health status. This will take approximately another 30 minutes. You may or may not&#xD;
      receive the small telemonitor (about as big as a large book) for 14 days after discharge to&#xD;
      provide additional information to the researchers. If you receive the monitor for the full 14&#xD;
      days, you or someone you ask us to train will be taught to use the monitor every morning to&#xD;
      collect information on how you will &quot;talk&quot; to you to tell you to put a blood pressure cuff on&#xD;
      your arm and an oxygen measurer on your finger. You will step on a scale to take your weight&#xD;
      and you will use a forehead sensor to take your temperature. The blood pressure, weight,&#xD;
      temperature, your pulse, and your oxygen level will be recorded by the monitor. It will then&#xD;
      ask you at least 10 questions and you will push a yes or no button indicating how much&#xD;
      difficulty you are having with your daily activities and shortness of breath. The monitor&#xD;
      will then connect to your telephone line using a no-charge &quot;800&quot; number and transmit the&#xD;
      information to the researchers. If you do not have a phone, a special antenna will be&#xD;
      connected to the monitor to transmit the information wirelessly. The nurse will call you&#xD;
      every day for the 14 days when you have the monitor. If you do not receive the monitor for&#xD;
      the full 14 days, you will still have the monitor used by the nurse when you are visited at&#xD;
      least 3 times at home to gather information on how you are doing after hospital discharge.&#xD;
      These home monitor visits will be within 2 days after discharge, 2 weeks after discharge, and&#xD;
      2 months after discharge. The main difference is that the monitor will not be left in your&#xD;
      home but will be brought by the nurse on each visit. You will also receive a phone call to&#xD;
      ask you questions about the study at 1 month after discharge. If you do not have a phone, you&#xD;
      will receive another home visit. Whether or not you get the monitor for the full 14 days will&#xD;
      be determined randomly by computer before the nurse visits you at home the first time. are&#xD;
      doing. The monitor will turn on each day at the same time; the monitor&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 2011</start_date>
  <completion_date type="Actual">June 2013</completion_date>
  <primary_completion_date type="Actual">December 2012</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in Telemonitor Data From Baseline: Temperature</measure>
    <time_frame>14 days</time_frame>
    <description>Changes in temperature measured by telemonitor daily over 14 days after hospital discharge</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in Telemonitor Data From Baseline: Pulse Rate</measure>
    <time_frame>14 days</time_frame>
    <description>Changes in pulse rate measured by telemonitor daily over 14 days after hospital discharge</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in Telemonitor Data From Baseline: Blood Pressure</measure>
    <time_frame>14 days</time_frame>
    <description>Changes in blood pressure measured by telemonitor daily over 14 days after hospital discharge</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in Telemonitor Data From Baseline: SpO2</measure>
    <time_frame>14 days</time_frame>
    <description>Changes in SpO2 measured by telemonitor daily over 14 days after hospital discharge</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in Telemonitor Data From Baseline: Weight</measure>
    <time_frame>14 days</time_frame>
    <description>Changes in weight measured by telemonitor daily over 14 days after hospital discharge</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in Telemonitor Symptoms Recorded From Baseline: Dyspnea</measure>
    <time_frame>14 days</time_frame>
    <description>Numeric rating for dyspnea, from 0 to 10 with a lower number being a decrease in dysnea. Symptom data requiring yes-no answers to whether the symptom is worse today than yesterday : dyspnea are collected daily via telemonitor for 14 days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Telemonitor Symptoms Recorded From Baseline: Functioning</measure>
    <time_frame>14 days</time_frame>
    <description>Pulmonary Functional Status Scale (PFSS-11) , scoring from 0 to 10 with increasing scores indicating an improvement in functioning. Symptom data requiring yes-no answers to whether the symptom is worse today than yesterday : general functioning activities, are collected daily via telemonitor for 14 days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Telemonitor Symptoms Recorded From Baseline: Pain</measure>
    <time_frame>14 days</time_frame>
    <description>Numeric rating for pain (0 to 10 scale) with a lower number indicating less pain. Symptom data requiring yes-no answers to whether the symptom is worse today than yesterday : pain are collected daily via telemonitor for 14 days.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">47</enrollment>
  <condition>Lung Cancer</condition>
  <arm_group>
    <arm_group_label>Telemonitor</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In addition to routine care, the &quot;HomMed Telemonitor&quot; wireless telemonitoring system (intervention)will be used in the patient's home for 14 days to alert the clinical research nurse to changes in patients conditions in order to contact them to teach self-management. The Honeywell HomMed Genesis™ DM Remote Patient Care Monitor will be used to measure temperature, pulse, oxygen level,weight and blood pressure. The telemonitor will also ask for a YES or NO response to questions on symptoms such as difficulty breathing. Research nurses review the data daily and call the participant for 2 weeks, and continue to monitor outcomes for 2 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Routine care for patients with lungCa</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Traditional physician ordered post-hospital care for patients with lung CA in rural WV requires patients to make an outpatient office/ clinic visit two to three weeks after discharge;a few patients receive homecare service referrals. No attempt to change care - just monitor what is used and collect study data at Discharge, 2 weeks, one month and two months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>HomMed Telemonitor</intervention_name>
    <description>A &quot;HomMed Telemonitor&quot; wireless telemonitoring system collects data on a daily basis, including heart rate, blood pressure, oxygen level, body temperature, weight, responses to 9 pre-programmed questions (including difficulty breathing, fatigue, limited activities, difficulty taking meds, pain). Telemonitored results are transmitted to the research office for analysis and contact to patient by clinical research nurses.</description>
    <arm_group_label>Telemonitor</arm_group_label>
    <other_name>Honeywell HomMed Genesis™ DM Remote Patient Care Monitor</other_name>
    <other_name>http://hommed.com/Products/Genesis_DM.asp</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        (1) patients admitted to the hospital for lung CA as a primary or secondary diagnosis; (2)&#xD;
        at least 45 years of age and up to 90 years old; (3) stable mental status and ability to&#xD;
        speak (but not necessarily read) the primary language of the region (English).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. are not discharged to home settings&#xD;
&#xD;
          2. are discharged to hospice&#xD;
&#xD;
          3. display a verbalized inability to understand or answer the questionnaires, (4) are&#xD;
             disqualified at the discretion of the treating physician, and/or (4) live beyond a 75&#xD;
             mile radius of the hospital.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Georgia L Narsavage, PhD, MSN</last_name>
    <role>Principal Investigator</role>
    <affiliation>West Virginia University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>WVU Mary Babb Randolph Cancer Center and Ruby 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>
  <reference>
    <citation>Chen YJ, Narsavage GL, Culp SL, Weaver TE. The development and psychometric analysis of the short-form Pulmonary Functional Status Scale (PFSS-11). Res Nurs Health. 2010 Dec;33(6):477-85. doi: 10.1002/nur.20403. Epub 2010 Oct 18.</citation>
    <PMID>20957666</PMID>
  </reference>
  <reference>
    <citation>Narsavage G, Romeo E. Education and support needs of younger and older cancer survivors. Appl Nurs Res. 2003 May;16(2):103-9. doi: 10.1016/s0897-1897(03)00008-9.</citation>
    <PMID>12764721</PMID>
  </reference>
  <reference>
    <citation>Narsavage GL, Naylor MD. Factors associated with referral of elderly individuals with cardiac and pulmonary disorders for home care services following hospital discharge. J Gerontol Nurs. 2000 May;26(5):14-20. doi: 10.3928/0098-9134-20000501-08.</citation>
    <PMID>11111516</PMID>
  </reference>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>August 9, 2012</study_first_submitted>
  <study_first_submitted_qc>August 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2012</study_first_posted>
  <results_first_submitted>August 11, 2021</results_first_submitted>
  <results_first_submitted_qc>December 20, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">January 20, 2022</results_first_posted>
  <last_update_submitted>September 23, 2022</last_update_submitted>
  <last_update_submitted_qc>September 23, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 18, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Lung Cancer</keyword>
  <keyword>Telemonitoring</keyword>
  <keyword>Rural</keyword>
  <keyword>Nursing</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Triamcinolone</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Subjects were enrolled from West Virginia University Ruby Memorial Hospital (WVUH) and the Mary Babb Randolph Cancer Center (MBRCC) at WVUH. The study subject recruitment began in April, 2011 and terminated at the end of December 2012.</recruitment_details>
      <pre_assignment_details>Two visits were needed in hospital to explain study prior to requesting consent in order to address literacy and provide opportunity for family member to be present. Time 1 data were collected at time of consent and then patients were assigned to groups prior to discharge.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Telemonitor</title>
          <description>In addition to routine care, the &quot;HomMed Telemonitor&quot; wireless telemonitoring system (intervention)will be used in the patient's home for 14 days to alert the clinical research nurse to changes in patients conditions in order to contact them to teach self-management. The Honeywell HomMed Genesis™ DM Remote Patient Care Monitor will be used to measure temperature, pulse, oxygen level,weight and blood pressure. The telemonitor will also ask for a YES or NO response to questions on symptoms such as difficulty breathing. Research nurses review the data daily and call the participant for 2 weeks, and continue to monitor outcomes for 2 months.&#xD;
HomMed Telemonitor: A &quot;HomMed Telemonitor&quot; wireless telemonitoring system collects data on a daily basis, including heart rate, blood pressure, oxygen level, body temperature, weight, responses to 9 pre-programmed questions (including difficulty breathing, fatigue, limited activities, difficulty taking meds, pain).</description>
        </group>
        <group group_id="P2">
          <title>Routine Care for Patients With lungCa</title>
          <description>Traditional physician ordered post-hospital care for patients with lung CA in rural WV requires patients to make an outpatient office/ clinic visit two to three weeks after discharge;a few patients receive homecare service referrals. No attempt to change care - just monitor what is used and collect study data at Discharge, 2 weeks, one month and two months.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="26"/>
                <participants group_id="P2" count="21"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="16"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>PI has left the institution and a report about the results was found, but the information within the report is not always broken down between the arms.</population>
      <group_list>
        <group group_id="B1">
          <title>Telemonitor and Routine Care for Patients With lungCa</title>
          <description>PI left the institution and demographic information was not broken down into arms.&#xD;
Telemonitor:&#xD;
In addition to routine care, the &quot;HomMed Telemonitor&quot; wireless telemonitoring system (intervention)will be used in the patient's home for 14 days to alert the clinical research nurse to changes in patients conditions in order to contact them to teach self-management. The Honeywell HomMed Genesis™ DM Remote Patient Care Monitor will be used to measure temperature, pulse, oxygen level,weight and blood pressure. The telemonitor will also ask for a YES or NO response to questions on symptoms such as difficulty breathing. Research nurses review the data daily and call the participant for 2 weeks, and continue to monitor outcomes for 2 months.&#xD;
HomMed Telemonitor: A &quot;HomMed Telemonitor&quot; wireless telemonitoring system collects data on a daily basis, including heart rate, blood pressure, oxygen level, body temperature, weight, responses to 9 pre-programmed questions (including difficulty breathing, fatigue, limited activities, difficulty taking meds, pain).&#xD;
Routine care for patients with lungCa:&#xD;
Traditional physician ordered post-hospital care for patients with lung CA in rural WV requires patients to make an outpatient office/ clinic visit two to three weeks after discharge;a few patients receive homecare service referrals. No attempt to change care - just monitor what is used and collect study data at Discharge, 2 weeks, one month and two months.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="47"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="47"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="63" spread="9.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <description>All efforts have been made to contact the PI, but the only available information is a small results document. The results information found was not always broken down by arm and the gender and race information provided include information from a 10 person sub-study. It cannot be determined which participants were from the sub-study, so information related to gender and race for this specific study cannot be determined.</description>
          <population>All efforts have been made to contact the PI, but the only available information is a small results document. The results information found was not always broken down by arm and the gender and race information provided include information from a 10 person sub-study. It cannot be determined which participants were from the sub-study, so information related to gender and race for this specific study cannot be determined.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <description>All efforts have been made to contact the PI, but the only available information is a small results document. The results information found was not always broken down by arm and the gender and race information provided include information from a 10 person sub-study. It cannot be determined which participants were from the sub-study, so information related to gender and race for this specific study cannot be determined.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="47"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Changes in Telemonitor Data From Baseline: Temperature</title>
        <description>Changes in temperature measured by telemonitor daily over 14 days after hospital discharge</description>
        <time_frame>14 days</time_frame>
        <population>Results information was not available broken down by arm.</population>
        <group_list>
          <group group_id="O1">
            <title>Telemonitor and Routine Care for Patients With lungCa</title>
            <description>PI left the institution and demographic information was not broken down into arms.&#xD;
Telemonitor:&#xD;
In addition to routine care, the &quot;HomMed Telemonitor&quot; wireless telemonitoring system (intervention)will be used in the patient's home for 14 days to alert the clinical research nurse to changes in patients conditions in order to contact them to teach self-management. The Honeywell HomMed Genesis™ DM Remote Patient Care Monitor will be used to measure temperature, pulse, oxygen level,weight and blood pressure. The telemonitor will also ask for a YES or NO response to questions on symptoms such as difficulty breathing. Research nurses review the data daily and call the participant for 2 weeks, and continue to monitor outcomes for 2 months.&#xD;
HomMed Telemonitor: A &quot;HomMed Telemonitor&quot; wireless telemonitoring system collects data on a daily basis, including heart rate, blood pressure, oxygen level, body temperature, weight, responses to 9 pre-programmed questions (including difficulty breathing, fatigue, limited activities, difficulty taking meds, pain).&#xD;
Routine care for patients with lungCa:&#xD;
Traditional physician ordered post-hospital care for patients with lung CA in rural WV requires patients to make an outpatient office/ clinic visit two to three weeks after discharge;a few patients receive homecare service referrals. No attempt to change care - just monitor what is used and collect study data at Discharge, 2 weeks, one month and two months.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Telemonitor Data From Baseline: Temperature</title>
          <description>Changes in temperature measured by telemonitor daily over 14 days after hospital discharge</description>
          <population>Results information was not available broken down by arm.</population>
          <units>Degrees Fahrenheit</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="47"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.05" lower_limit="96.6" upper_limit="97.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Changes in Telemonitor Data From Baseline: Pulse Rate</title>
        <description>Changes in pulse rate measured by telemonitor daily over 14 days after hospital discharge</description>
        <time_frame>14 days</time_frame>
        <population>Results information was not available broken down by arm</population>
        <group_list>
          <group group_id="O1">
            <title>Telemonitor and Routine Care for Patients With lungCa</title>
            <description>PI left the institution and demographic information was not broken down into arms.&#xD;
Telemonitor:&#xD;
In addition to routine care, the &quot;HomMed Telemonitor&quot; wireless telemonitoring system (intervention)will be used in the patient's home for 14 days to alert the clinical research nurse to changes in patients conditions in order to contact them to teach self-management. The Honeywell HomMed Genesis™ DM Remote Patient Care Monitor will be used to measure temperature, pulse, oxygen level,weight and blood pressure. The telemonitor will also ask for a YES or NO response to questions on symptoms such as difficulty breathing. Research nurses review the data daily and call the participant for 2 weeks, and continue to monitor outcomes for 2 months.&#xD;
HomMed Telemonitor: A &quot;HomMed Telemonitor&quot; wireless telemonitoring system collects data on a daily basis, including heart rate, blood pressure, oxygen level, body temperature, weight, responses to 9 pre-programmed questions (including difficulty breathing, fatigue, limited activities, difficulty taking meds, pain).&#xD;
Routine care for patients with lungCa:&#xD;
Traditional physician ordered post-hospital care for patients with lung CA in rural WV requires patients to make an outpatient office/ clinic visit two to three weeks after discharge;a few patients receive homecare service referrals. No attempt to change care - just monitor what is used and collect study data at Discharge, 2 weeks, one month and two months.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Telemonitor Data From Baseline: Pulse Rate</title>
          <description>Changes in pulse rate measured by telemonitor daily over 14 days after hospital discharge</description>
          <population>Results information was not available broken down by arm</population>
          <units>beats per minutes (bpm)</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="47"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93" lower_limit="89" upper_limit="97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Changes in Telemonitor Data From Baseline: Blood Pressure</title>
        <description>Changes in blood pressure measured by telemonitor daily over 14 days after hospital discharge</description>
        <time_frame>14 days</time_frame>
        <population>Results information was not available broken down by arm</population>
        <group_list>
          <group group_id="O1">
            <title>Telemonitor and Routine Care for Patients With lungCa</title>
            <description>PI left the institution and demographic information was not broken down into arms.&#xD;
Telemonitor:&#xD;
In addition to routine care, the &quot;HomMed Telemonitor&quot; wireless telemonitoring system (intervention)will be used in the patient's home for 14 days to alert the clinical research nurse to changes in patients conditions in order to contact them to teach self-management. The Honeywell HomMed Genesis™ DM Remote Patient Care Monitor will be used to measure temperature, pulse, oxygen level,weight and blood pressure. The telemonitor will also ask for a YES or NO response to questions on symptoms such as difficulty breathing. Research nurses review the data daily and call the participant for 2 weeks, and continue to monitor outcomes for 2 months.&#xD;
HomMed Telemonitor: A &quot;HomMed Telemonitor&quot; wireless telemonitoring system collects data on a daily basis, including heart rate, blood pressure, oxygen level, body temperature, weight, responses to 9 pre-programmed questions (including difficulty breathing, fatigue, limited activities, difficulty taking meds, pain).&#xD;
Routine care for patients with lungCa:&#xD;
Traditional physician ordered post-hospital care for patients with lung CA in rural WV requires patients to make an outpatient office/ clinic visit two to three weeks after discharge;a few patients receive homecare service referrals. No attempt to change care - just monitor what is used and collect study data at Discharge, 2 weeks, one month and two months.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Telemonitor Data From Baseline: Blood Pressure</title>
          <description>Changes in blood pressure measured by telemonitor daily over 14 days after hospital discharge</description>
          <population>Results information was not available broken down by arm</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="47"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Diastolic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69.5" lower_limit="66" upper_limit="73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Systolic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="122" lower_limit="115" upper_limit="129"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Changes in Telemonitor Data From Baseline: SpO2</title>
        <description>Changes in SpO2 measured by telemonitor daily over 14 days after hospital discharge</description>
        <time_frame>14 days</time_frame>
        <population>Results information was not available broken down by arm.</population>
        <group_list>
          <group group_id="O1">
            <title>Telemonitor and Routine Care for Patients With lungCa</title>
            <description>PI left the institution and demographic information was not broken down into arms.&#xD;
Telemonitor:&#xD;
In addition to routine care, the &quot;HomMed Telemonitor&quot; wireless telemonitoring system (intervention)will be used in the patient's home for 14 days to alert the clinical research nurse to changes in patients conditions in order to contact them to teach self-management. The Honeywell HomMed Genesis™ DM Remote Patient Care Monitor will be used to measure temperature, pulse, oxygen level,weight and blood pressure. The telemonitor will also ask for a YES or NO response to questions on symptoms such as difficulty breathing. Research nurses review the data daily and call the participant for 2 weeks, and continue to monitor outcomes for 2 months.&#xD;
HomMed Telemonitor: A &quot;HomMed Telemonitor&quot; wireless telemonitoring system collects data on a daily basis, including heart rate, blood pressure, oxygen level, body temperature, weight, responses to 9 pre-programmed questions (including difficulty breathing, fatigue, limited activities, difficulty taking meds, pain).&#xD;
Routine care for patients with lungCa:&#xD;
Traditional physician ordered post-hospital care for patients with lung CA in rural WV requires patients to make an outpatient office/ clinic visit two to three weeks after discharge;a few patients receive homecare service referrals. No attempt to change care - just monitor what is used and collect study data at Discharge, 2 weeks, one month and two months.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Telemonitor Data From Baseline: SpO2</title>
          <description>Changes in SpO2 measured by telemonitor daily over 14 days after hospital discharge</description>
          <population>Results information was not available broken down by arm.</population>
          <units>percentage of oxygen</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="47"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93.5" lower_limit="92" upper_limit="95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Changes in Telemonitor Data From Baseline: Weight</title>
        <description>Changes in weight measured by telemonitor daily over 14 days after hospital discharge</description>
        <time_frame>14 days</time_frame>
        <population>Results information was not available broken down by arm.</population>
        <group_list>
          <group group_id="O1">
            <title>Telemonitor and Routine Care for Patients With lungCa</title>
            <description>PI left the institution and demographic information was not broken down into arms.&#xD;
Telemonitor:&#xD;
In addition to routine care, the &quot;HomMed Telemonitor&quot; wireless telemonitoring system (intervention)will be used in the patient's home for 14 days to alert the clinical research nurse to changes in patients conditions in order to contact them to teach self-management. The Honeywell HomMed Genesis™ DM Remote Patient Care Monitor will be used to measure temperature, pulse, oxygen level,weight and blood pressure. The telemonitor will also ask for a YES or NO response to questions on symptoms such as difficulty breathing. Research nurses review the data daily and call the participant for 2 weeks, and continue to monitor outcomes for 2 months.&#xD;
HomMed Telemonitor: A &quot;HomMed Telemonitor&quot; wireless telemonitoring system collects data on a daily basis, including heart rate, blood pressure, oxygen level, body temperature, weight, responses to 9 pre-programmed questions (including difficulty breathing, fatigue, limited activities, difficulty taking meds, pain).&#xD;
Routine care for patients with lungCa:&#xD;
Traditional physician ordered post-hospital care for patients with lung CA in rural WV requires patients to make an outpatient office/ clinic visit two to three weeks after discharge;a few patients receive homecare service referrals. No attempt to change care - just monitor what is used and collect study data at Discharge, 2 weeks, one month and two months.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Telemonitor Data From Baseline: Weight</title>
          <description>Changes in weight measured by telemonitor daily over 14 days after hospital discharge</description>
          <population>Results information was not available broken down by arm.</population>
          <units>pounds</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="47"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="161.5" lower_limit="155" upper_limit="168"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Telemonitor Symptoms Recorded From Baseline: Dyspnea</title>
        <description>Numeric rating for dyspnea, from 0 to 10 with a lower number being a decrease in dysnea. Symptom data requiring yes-no answers to whether the symptom is worse today than yesterday : dyspnea are collected daily via telemonitor for 14 days.</description>
        <time_frame>14 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Telemonitor</title>
            <description>In addition to routine care, the &quot;HomMed Telemonitor&quot; wireless telemonitoring system (intervention)will be used in the patient's home for 14 days to alert the clinical research nurse to changes in patients conditions in order to contact them to teach self-management. The Honeywell HomMed Genesis™ DM Remote Patient Care Monitor will be used to measure temperature, pulse, oxygen level,weight and blood pressure. The telemonitor will also ask for a YES or NO response to questions on symptoms such as difficulty breathing. Research nurses review the data daily and call the participant for 2 weeks, and continue to monitor outcomes for 2 months.&#xD;
HomMed Telemonitor: A &quot;HomMed Telemonitor&quot; wireless telemonitoring system collects data on a daily basis, including heart rate, blood pressure, oxygen level, body temperature, weight, responses to 9 pre-programmed questions (including difficulty breathing, fatigue, limited activities, difficulty taking meds, pain).</description>
          </group>
          <group group_id="O2">
            <title>Routine Care for Patients With lungCa</title>
            <description>Traditional physician ordered post-hospital care for patients with lung CA in rural WV requires patients to make an outpatient office/ clinic visit two to three weeks after discharge;a few patients receive homecare service referrals. No attempt to change care - just monitor what is used and collect study data at Discharge, 2 weeks, one month and two months.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Telemonitor Symptoms Recorded From Baseline: Dyspnea</title>
          <description>Numeric rating for dyspnea, from 0 to 10 with a lower number being a decrease in dysnea. Symptom data requiring yes-no answers to whether the symptom is worse today than yesterday : dyspnea are collected daily via telemonitor for 14 days.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.8" lower_limit="3.7" upper_limit="3.8"/>
                    <measurement group_id="O2" value="2" lower_limit="2" upper_limit="3.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Telemonitor Symptoms Recorded From Baseline: Functioning</title>
        <description>Pulmonary Functional Status Scale (PFSS-11) , scoring from 0 to 10 with increasing scores indicating an improvement in functioning. Symptom data requiring yes-no answers to whether the symptom is worse today than yesterday : general functioning activities, are collected daily via telemonitor for 14 days.</description>
        <time_frame>14 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Telemonitor</title>
            <description>In addition to routine care, the &quot;HomMed Telemonitor&quot; wireless telemonitoring system (intervention)will be used in the patient's home for 14 days to alert the clinical research nurse to changes in patients conditions in order to contact them to teach self-management. The Honeywell HomMed Genesis™ DM Remote Patient Care Monitor will be used to measure temperature, pulse, oxygen level,weight and blood pressure. The telemonitor will also ask for a YES or NO response to questions on symptoms such as difficulty breathing. Research nurses review the data daily and call the participant for 2 weeks, and continue to monitor outcomes for 2 months.&#xD;
HomMed Telemonitor: A &quot;HomMed Telemonitor&quot; wireless telemonitoring system collects data on a daily basis, including heart rate, blood pressure, oxygen level, body temperature, weight, responses to 9 pre-programmed questions (including difficulty breathing, fatigue, limited activities, difficulty taking meds, pain).</description>
          </group>
          <group group_id="O2">
            <title>Routine Care for Patients With lungCa</title>
            <description>Traditional physician ordered post-hospital care for patients with lung CA in rural WV requires patients to make an outpatient office/ clinic visit two to three weeks after discharge;a few patients receive homecare service referrals. No attempt to change care - just monitor what is used and collect study data at Discharge, 2 weeks, one month and two months.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Telemonitor Symptoms Recorded From Baseline: Functioning</title>
          <description>Pulmonary Functional Status Scale (PFSS-11) , scoring from 0 to 10 with increasing scores indicating an improvement in functioning. Symptom data requiring yes-no answers to whether the symptom is worse today than yesterday : general functioning activities, are collected daily via telemonitor for 14 days.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.6" lower_limit="2.8" upper_limit="3.6"/>
                    <measurement group_id="O2" value="3.2" lower_limit="3.1" upper_limit="3.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Telemonitor Symptoms Recorded From Baseline: Pain</title>
        <description>Numeric rating for pain (0 to 10 scale) with a lower number indicating less pain. Symptom data requiring yes-no answers to whether the symptom is worse today than yesterday : pain are collected daily via telemonitor for 14 days.</description>
        <time_frame>14 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Telemonitor</title>
            <description>In addition to routine care, the &quot;HomMed Telemonitor&quot; wireless telemonitoring system (intervention)will be used in the patient's home for 14 days to alert the clinical research nurse to changes in patients conditions in order to contact them to teach self-management. The Honeywell HomMed Genesis™ DM Remote Patient Care Monitor will be used to measure temperature, pulse, oxygen level,weight and blood pressure. The telemonitor will also ask for a YES or NO response to questions on symptoms such as difficulty breathing. Research nurses review the data daily and call the participant for 2 weeks, and continue to monitor outcomes for 2 months.&#xD;
HomMed Telemonitor: A &quot;HomMed Telemonitor&quot; wireless telemonitoring system collects data on a daily basis, including heart rate, blood pressure, oxygen level, body temperature, weight, responses to 9 pre-programmed questions (including difficulty breathing, fatigue, limited activities, difficulty taking meds, pain).</description>
          </group>
          <group group_id="O2">
            <title>Routine Care for Patients With lungCa</title>
            <description>Traditional physician ordered post-hospital care for patients with lung CA in rural WV requires patients to make an outpatient office/ clinic visit two to three weeks after discharge;a few patients receive homecare service referrals. No attempt to change care - just monitor what is used and collect study data at Discharge, 2 weeks, one month and two months.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Telemonitor Symptoms Recorded From Baseline: Pain</title>
          <description>Numeric rating for pain (0 to 10 scale) with a lower number indicating less pain. Symptom data requiring yes-no answers to whether the symptom is worse today than yesterday : pain are collected daily via telemonitor for 14 days.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.8" lower_limit="2.8" upper_limit="4"/>
                    <measurement group_id="O2" value="2.8" lower_limit="2.8" upper_limit="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <desc>The PI left the institution and a small results document has been found, the documents does not contain adverse events information. All efforts were to made to retrieve adverse events information, but were unsuccessful.</desc>
      <group_list>
        <group group_id="E1">
          <title>Telemonitor</title>
          <description>In addition to routine care, the &quot;HomMed Telemonitor&quot; wireless telemonitoring system (intervention)will be used in the patient's home for 14 days to alert the clinical research nurse to changes in patients conditions in order to contact them to teach self-management. The Honeywell HomMed Genesis™ DM Remote Patient Care Monitor will be used to measure temperature, pulse, oxygen level,weight and blood pressure. The telemonitor will also ask for a YES or NO response to questions on symptoms such as difficulty breathing. Research nurses review the data daily and call the participant for 2 weeks, and continue to monitor outcomes for 2 months.&#xD;
HomMed Telemonitor: A &quot;HomMed Telemonitor&quot; wireless telemonitoring system collects data on a daily basis, including heart rate, blood pressure, oxygen level, body temperature, weight, responses to 9 pre-programmed questions (including difficulty breathing, fatigue, limited activities, difficulty taking meds, pain). Telemonitored results are transmitted to the research office for analysis and contact to patient by clinical research nurses.</description>
        </group>
        <group group_id="E2">
          <title>Routine Care for Patients With lungCa</title>
          <description>Traditional physician ordered post-hospital care for patients with lung CA in rural WV requires patients to make an outpatient office/ clinic visit two to three weeks after discharge;a few patients receive homecare service referrals. No attempt to change care - just monitor what is used and collect study data at Discharge, 2 weeks, one month and two months.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Georgia L Narsavage</name_or_title>
      <organization>West Virginia University</organization>
      <phone>304-293-6729</phone>
      <email>gnarsavage@hsc.wvu.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01670539
org study id: H-22930
secondary id: 1R15CA150999
nct id: NCT01670539
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to learn more about using a home machine "Telemonitor" to find
      problems people with lung cancer may have after being discharged from the hospital and help
      them manage problems by contacting their healthcare provider.The study hypothesis is that
      patients with lung CA using short-term (14 days)home telemonitors, educated/coached by nurses
      on telemonitor data risks/implications for the first two weeks after hospital discharge, will
      be able to self-report their signs/ symptoms to the clinician resulting in decreased use of
      costly health care resources over 60 days.
All patients in the study will receive usual care after hospital discharge. This study also
      involves an interview and review of your medical records, and uses the "telemonitor" machine
      to measure your temperature, pulse, oxygen level,weight and blood pressure. The telemonitor
      will also ask you to press YES or NO buttons in response to questions on your symptoms such
      as difficulty breathing. Research nurses will come to your home 3 times and it will take
      about 30 minutes for each visit for the nurse to record the information using the
      telemonitor. You will also be asked to fill out a survey about your ability to do activities
      and your health status. This will take approximately another 30 minutes. You may or may not
      receive the small telemonitor (about as big as a large book) for 14 days after discharge to
      provide additional information to the researchers. If you receive the monitor for the full 14
      days, you or someone you ask us to train will be taught to use the monitor every morning to
      collect information on how you will "talk" to you to tell you to put a blood pressure cuff on
      your arm and an oxygen measurer on your finger. You will step on a scale to take your weight
      and you will use a forehead sensor to take your temperature. The blood pressure, weight,
      temperature, your pulse, and your oxygen level will be recorded by the monitor. It will then
      ask you at least 10 questions and you will push a yes or no button indicating how much
      difficulty you are having with your daily activities and shortness of breath. The monitor
      will then connect to your telephone line using a no-charge "800" number and transmit the
      information to the researchers. If you do not have a phone, a special antenna will be
      connected to the monitor to transmit the information wirelessly. The nurse will call you
      every day for the 14 days when you have the monitor. If you do not receive the monitor for
      the full 14 days, you will still have the monitor used by the nurse when you are visited at
      least 3 times at home to gather information on how you are doing after hospital discharge.
      These home monitor visits will be within 2 days after discharge, 2 weeks after discharge, and
      2 months after discharge. The main difference is that the monitor will not be left in your
      home but will be brought by the nurse on each visit. You will also receive a phone call to
      ask you questions about the study at 1 month after discharge. If you do not have a phone, you
      will receive another home visit. Whether or not you get the monitor for the full 14 days will
      be determined randomly by computer before the nurse visits you at home the first time. are
      doing. The monitor will turn on each day at the same time; the monitor
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Changes in Telemonitor Data From Baseline: Temperature
time frame: 14 days
description: Changes in temperature measured by telemonitor daily over 14 days after hospital discharge
measure: Changes in Telemonitor Data From Baseline: Pulse Rate
time frame: 14 days
description: Changes in pulse rate measured by telemonitor daily over 14 days after hospital discharge
measure: Changes in Telemonitor Data From Baseline: Blood Pressure
time frame: 14 days
description: Changes in blood pressure measured by telemonitor daily over 14 days after hospital discharge
measure: Changes in Telemonitor Data From Baseline: SpO2
time frame: 14 days
description: Changes in SpO2 measured by telemonitor daily over 14 days after hospital discharge
measure: Changes in Telemonitor Data From Baseline: Weight
time frame: 14 days
description: Changes in weight measured by telemonitor daily over 14 days after hospital discharge
measure: Changes in Telemonitor Symptoms Recorded From Baseline: Dyspnea
time frame: 14 days
description: Numeric rating for dyspnea, from 0 to 10 with a lower number being a decrease in dysnea. Symptom data requiring yes-no answers to whether the symptom is worse today than yesterday : dyspnea are collected daily via telemonitor for 14 days.
measure: Changes in Telemonitor Symptoms Recorded From Baseline: Functioning
time frame: 14 days
description: Pulmonary Functional Status Scale (PFSS-11) , scoring from 0 to 10 with increasing scores indicating an improvement in functioning. Symptom data requiring yes-no answers to whether the symptom is worse today than yesterday : general functioning activities, are collected daily via telemonitor for 14 days.
measure: Changes in Telemonitor Symptoms Recorded From Baseline: Pain
time frame: 14 days
description: Numeric rating for pain (0 to 10 scale) with a lower number indicating less pain. Symptom data requiring yes-no answers to whether the symptom is worse today than yesterday : pain are collected daily via telemonitor for 14 days.
arm group label: Telemonitor
arm group type: Experimental
description: In addition to routine care, the "HomMed Telemonitor" wireless telemonitoring system (intervention)will be used in the patient's home for 14 days to alert the clinical research nurse to changes in patients conditions in order to contact them to teach self-management. The Honeywell HomMed Genesis™ DM Remote Patient Care Monitor will be used to measure temperature, pulse, oxygen level,weight and blood pressure. The telemonitor will also ask for a YES or NO response to questions on symptoms such as difficulty breathing. Research nurses review the data daily and call the participant for 2 weeks, and continue to monitor outcomes for 2 months.
arm group label: Routine care for patients with lungCa
arm group type: No Intervention
description: Traditional physician ordered post-hospital care for patients with lung CA in rural WV requires patients to make an outpatient office/ clinic visit two to three weeks after discharge;a few patients receive homecare service referrals. No attempt to change care - just monitor what is used and collect study data at Discharge, 2 weeks, one month and two months.
intervention type: Device
intervention name: HomMed Telemonitor
description: A "HomMed Telemonitor" wireless telemonitoring system collects data on a daily basis, including heart rate, blood pressure, oxygen level, body temperature, weight, responses to 9 pre-programmed questions (including difficulty breathing, fatigue, limited activities, difficulty taking meds, pain). Telemonitored results are transmitted to the research office for analysis and contact to patient by clinical research nurses.
arm group label: Telemonitor
other name: Honeywell HomMed Genesis™ DM Remote Patient Care Monitor
other name: http://hommed.com/Products/Genesis_DM.asp
criteria: 
gender: All
minimum age: 45 Years
maximum age: 90 Years
healthy volunteers: No
last name: Georgia L Narsavage, PhD, MSN
role: Principal Investigator
affiliation: West Virginia University
facility: 
country: United States
citation: Chen YJ, Narsavage GL, Culp SL, Weaver TE. The development and psychometric analysis of the short-form Pulmonary Functional Status Scale (PFSS-11). Res Nurs Health. 2010 Dec;33(6):477-85. doi: 10.1002/nur.20403. Epub 2010 Oct 18.
PMID: 20957666
citation: Narsavage G, Romeo E. Education and support needs of younger and older cancer survivors. Appl Nurs Res. 2003 May;16(2):103-9. doi: 10.1016/s0897-1897(03)00008-9.
PMID: 12764721
citation: Narsavage GL, Naylor MD. Factors associated with referral of elderly individuals with cardiac and pulmonary disorders for home care services following hospital discharge. J Gerontol Nurs. 2000 May;26(5):14-20. doi: 10.3928/0098-9134-20000501-08.
PMID: 11111516
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Triamcinolone
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 