<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/NCT03792698</url>
  </required_header>
  <id_info>
    <org_study_id>831322</org_study_id>
    <nct_id>NCT03792698</nct_id>
  </id_info>
  <brief_title>Preventing Rehospitalization in Lung Transplant Recipients Utilizing mHealth</brief_title>
  <acronym>PERSPIRE</acronym>
  <official_title>Preventing Rehospitalization in Lung Transplant Recipients Through mHealth Utilizing Individualized Rehabilitation Prescriptions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pennsylvania</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Pennsylvania</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>
      Lung transplantation has several important aims: 1) extend survival; 2) relieve disability,&#xD;
      and 3) improve health-related quality of life (HRQL) for adults suffering from end-stage lung&#xD;
      disease. Advances in medical therapies and changes in the US organ allocation system in 2005&#xD;
      have prioritized lung transplant for sicker and older patients. This achievement has come at&#xD;
      substantial cost, including recent trends in recipients towards increased disability, poorer&#xD;
      health-related quality of life, and increased longer-term mortality. Additionally, lung&#xD;
      transplant recipients have the highest risk of unexpected readmission after the index&#xD;
      admission, with published rates of 40-43%. Frailty at the time of discharge is one of the&#xD;
      leading factors for readmission. The investigator's belief is that improving access to&#xD;
      individualized exercise training plans that are modified based on a patient's progress and&#xD;
      needs will greatly improve a transplant recipient's level of physical fitness and&#xD;
      independence, and decrease the risk of hospital readmission. This will lead to an overall&#xD;
      improvement in a patient's quality of life.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Mission and Specific Aims: Lung transplantation has several important aims: 1) extend&#xD;
      survival; 2) relieve disability, and 3) improve health-related quality of life (HRQL) for&#xD;
      adults suffering from end-stage lung disease. Advances in medical therapies and changes in&#xD;
      the US organ allocation system in 2005 have prioritized lung transplant for sicker and older&#xD;
      patients. This achievement has come at substantial cost, including recent trends in&#xD;
      recipients towards increased disability, poorer HRQL, and increased longer-term mortality.&#xD;
&#xD;
      Reflecting these trends, lung transplant recipients have the highest risk of unexpected&#xD;
      readmission after the index admission among solid organ transplant patients, with published&#xD;
      rates of 38-43%. Over the course of the first post-transplant year, the investigators have&#xD;
      shown that 60% of lung transplant recipients have a readmission within 30 days of a hospital&#xD;
      discharge, of which 30% occur after initial discharge (as above) and 70% occur after a&#xD;
      subsequent readmission (2). Each readmission increases the risk for another unplanned&#xD;
      rehospitalization as well as long-term mortality, suggesting that this is a particularly&#xD;
      vulnerable population.&#xD;
&#xD;
      Over the last year, the investigators performed a single center cohort study to identify risk&#xD;
      factors for readmission after index lung transplant discharge. As part of this initiative,&#xD;
      the investigators have been evaluating the role of frailty as measured by the Short Physical&#xD;
      Performance Battery (SPPB) test. The SPPB is a three-component battery of lower extremity&#xD;
      performance, measures that includes gait speed, chair stands, and balance. The investigators&#xD;
      have previously demonstrated that frailty is a risk factor for delisting and death among wait&#xD;
      listed lung transplant recipients as well as a significant predictor of mortality within the&#xD;
      first year after transplant (Figure 1)(3). In a recent single center cohort study of 90 Penn&#xD;
      lung transplant recipients, the investigators demonstrated that patients who are frail at&#xD;
      index hospitalization discharge based on SPPB are 3.4 times more likely to have an unplanned&#xD;
      re-hospitalization within the next 30 days, regardless of whether they are discharged home or&#xD;
      to acute rehab. Interestingly, patients are not frail at the time of listing for transplant -&#xD;
      frailty develops during the hospital stay for lung transplantation suggesting that physical&#xD;
      frailty is dynamic over a short period of time and may be amenable to intervention. The&#xD;
      frequent re-admissions, in part due to significant frailty, lead to 1) increased healthcare&#xD;
      expenditures (the median professional and hospital payments at Penn for an unplanned&#xD;
      hospitalization following discharge was $13048, 2) severely impact the patient's quality of&#xD;
      life, and 3) lead to increased mortality.&#xD;
&#xD;
      The investigators have previously found that, among recipients who were frail at discharge&#xD;
      and who were enrolled in an intensive outpatient physical therapy program, the median&#xD;
      improvement in SPPB was 6 points and 85.7% became not frail (unpublished data). Although this&#xD;
      demonstrates that frailty can be reversed in the lung transplant population, the impact of&#xD;
      reduced frailty on subsequent readmission has not been evaluated. It remains unknown whether&#xD;
      there are other, less resource intensive, mechanisms for improving frailty. The&#xD;
      investigator's belief is that improving access to individualize exercise training plans that&#xD;
      are modified based on a patient's progress and needs will greatly improve transplant&#xD;
      recipient's level of physical fitness and independence, and decrease the risk of hospital&#xD;
      readmission. This will lead to an overall improvement in a patient's quality of life. This&#xD;
      study, therefore, targets a population of lung transplant recipients at highest risk for&#xD;
      readmission and further complications.&#xD;
&#xD;
      Specific Aim: Evaluate the impact of targeted physical therapy rehabilitation plans utilizing&#xD;
      a customizable app based interface on the subsequent readmission rates of lung transplant&#xD;
      patients at the highest rate of readmission. Patients who are 1) frail at the time of&#xD;
      discharge (SPPB≤8) or 2) have already been readmitted after their transplant hospitalization&#xD;
      are at the highest risk of subsequent readmission. The investigators hypothesize that&#xD;
      targeted, individualized rehabilitation plans will reduce the risk of subsequent readmission.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 15, 2019</start_date>
  <completion_date type="Actual">June 1, 2020</completion_date>
  <primary_completion_date type="Actual">January 31, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Pre-post intervention study design</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Readmission</measure>
    <time_frame>one year</time_frame>
    <description>difference in readmission rate over the year prior to the above described intervention with the readmission rate in the setting of Aidcube app utilization</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Improved frailty score</measure>
    <time_frame>one year</time_frame>
    <description>Change in short physical performance battery (SPPB) scores</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health related quality of life</measure>
    <time_frame>one year</time_frame>
    <description>Change in HRQOL as measured by the Medical Outcomes Survey Short Form 12 (SF12). The SF12 is a 12 question survey designed to assess a subjects mental and physical functioning as well as overall health related quality of life. Physical and Mental Health Composite Scores (PCS &amp; MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. Both Physical and Mental Health Composite Scales combine the 12 items in such a way that they compare to a national norm with a mean score of 50.0 and a standard deviation of 10.0. Higher score indicated higher level of functioning.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Lung Transplant; Complications</condition>
  <arm_group>
    <arm_group_label>Aidcube utilization</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Aidcube is a fully customizable, commercially available digital &quot;app&quot;-based platform to deliver home-based pulmonary rehabilitation for patients. On the patient-facing side, patients can view their daily exercise prescription, descriptions and videos demonstrating correct execution of the exercises, document completion of exercises, and message their health-care provider. On the provider-facing side, from over 150 available exercises, surveys, and activities, providers can design a fully-customized exercise prescription. Based on real-time patient feedback, the exercise prescription can be progressed (i.e., advanced and/or modified) by adding repetitions or time to specific exercises or adding new activities. The provider can also message the patient from within the Aidcube environment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Aidcube digital app-based platform</intervention_name>
    <description>Use of customizable, patient-specific mHealth home rehabilitation plan</description>
    <arm_group_label>Aidcube utilization</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Lung transplant recipient&#xD;
&#xD;
          -  SPPB score less than or equal to 9 OR a readmission within 30 days of lung transplant&#xD;
             discharge&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  SPPB &gt;9&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>76 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of California San Francisco</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>December 14, 2018</study_first_submitted>
  <study_first_submitted_qc>January 2, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 3, 2019</study_first_posted>
  <last_update_submitted>June 3, 2020</last_update_submitted>
  <last_update_submitted_qc>June 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Pennsylvania</investigator_affiliation>
    <investigator_full_name>Joshua M. Diamond MD,MSCE</investigator_full_name>
    <investigator_title>Assistant Professor of Medicine</investigator_title>
  </responsible_party>
  <keyword>Lung Transplantation</keyword>
  <keyword>Frailty</keyword>
  <keyword>Readmisson</keyword>
  <keyword>Physical Therapy</keyword>
  <keyword>Personalized</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03792698
org study id: 831322
nct id: NCT03792698
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Lung transplantation has several important aims: 1) extend survival; 2) relieve disability,
      and 3) improve health-related quality of life (HRQL) for adults suffering from end-stage lung
      disease. Advances in medical therapies and changes in the US organ allocation system in 2005
      have prioritized lung transplant for sicker and older patients. This achievement has come at
      substantial cost, including recent trends in recipients towards increased disability, poorer
      health-related quality of life, and increased longer-term mortality. Additionally, lung
      transplant recipients have the highest risk of unexpected readmission after the index
      admission, with published rates of 40-43%. Frailty at the time of discharge is one of the
      leading factors for readmission. The investigator's belief is that improving access to
      individualized exercise training plans that are modified based on a patient's progress and
      needs will greatly improve a transplant recipient's level of physical fitness and
      independence, and decrease the risk of hospital readmission. This will lead to an overall
      improvement in a patient's quality of life.
Mission and Specific Aims: Lung transplantation has several important aims: 1) extend
      survival; 2) relieve disability, and 3) improve health-related quality of life (HRQL) for
      adults suffering from end-stage lung disease. Advances in medical therapies and changes in
      the US organ allocation system in 2005 have prioritized lung transplant for sicker and older
      patients. This achievement has come at substantial cost, including recent trends in
      recipients towards increased disability, poorer HRQL, and increased longer-term mortality.

      Reflecting these trends, lung transplant recipients have the highest risk of unexpected
      readmission after the index admission among solid organ transplant patients, with published
      rates of 38-43%. Over the course of the first post-transplant year, the investigators have
      shown that 60% of lung transplant recipients have a readmission within 30 days of a hospital
      discharge, of which 30% occur after initial discharge (as above) and 70% occur after a
      subsequent readmission (2). Each readmission increases the risk for another unplanned
      rehospitalization as well as long-term mortality, suggesting that this is a particularly
      vulnerable population.

      Over the last year, the investigators performed a single center cohort study to identify risk
      factors for readmission after index lung transplant discharge. As part of this initiative,
      the investigators have been evaluating the role of frailty as measured by the Short Physical
      Performance Battery (SPPB) test. The SPPB is a three-component battery of lower extremity
      performance, measures that includes gait speed, chair stands, and balance. The investigators
      have previously demonstrated that frailty is a risk factor for delisting and death among wait
      listed lung transplant recipients as well as a significant predictor of mortality within the
      first year after transplant (Figure 1)(3). In a recent single center cohort study of 90 Penn
      lung transplant recipients, the investigators demonstrated that patients who are frail at
      index hospitalization discharge based on SPPB are 3.4 times more likely to have an unplanned
      re-hospitalization within the next 30 days, regardless of whether they are discharged home or
      to acute rehab. Interestingly, patients are not frail at the time of listing for transplant -
      frailty develops during the hospital stay for lung transplantation suggesting that physical
      frailty is dynamic over a short period of time and may be amenable to intervention. The
      frequent re-admissions, in part due to significant frailty, lead to 1) increased healthcare
      expenditures (the median professional and hospital payments at Penn for an unplanned
      hospitalization following discharge was $13048, 2) severely impact the patient's quality of
      life, and 3) lead to increased mortality.

      The investigators have previously found that, among recipients who were frail at discharge
      and who were enrolled in an intensive outpatient physical therapy program, the median
      improvement in SPPB was 6 points and 85.7% became not frail (unpublished data). Although this
      demonstrates that frailty can be reversed in the lung transplant population, the impact of
      reduced frailty on subsequent readmission has not been evaluated. It remains unknown whether
      there are other, less resource intensive, mechanisms for improving frailty. The
      investigator's belief is that improving access to individualize exercise training plans that
      are modified based on a patient's progress and needs will greatly improve transplant
      recipient's level of physical fitness and independence, and decrease the risk of hospital
      readmission. This will lead to an overall improvement in a patient's quality of life. This
      study, therefore, targets a population of lung transplant recipients at highest risk for
      readmission and further complications.

      Specific Aim: Evaluate the impact of targeted physical therapy rehabilitation plans utilizing
      a customizable app based interface on the subsequent readmission rates of lung transplant
      patients at the highest rate of readmission. Patients who are 1) frail at the time of
      discharge (SPPB≤8) or 2) have already been readmitted after their transplant hospitalization
      are at the highest risk of subsequent readmission. The investigators hypothesize that
      targeted, individualized rehabilitation plans will reduce the risk of subsequent readmission.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Pre-post intervention study design
primary purpose: Treatment
masking: None (Open Label)
measure: Readmission
time frame: one year
description: difference in readmission rate over the year prior to the above described intervention with the readmission rate in the setting of Aidcube app utilization
measure: Improved frailty score
time frame: one year
description: Change in short physical performance battery (SPPB) scores
measure: Health related quality of life
time frame: one year
description: Change in HRQOL as measured by the Medical Outcomes Survey Short Form 12 (SF12). The SF12 is a 12 question survey designed to assess a subjects mental and physical functioning as well as overall health related quality of life. Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. Both Physical and Mental Health Composite Scales combine the 12 items in such a way that they compare to a national norm with a mean score of 50.0 and a standard deviation of 10.0. Higher score indicated higher level of functioning.
arm group label: Aidcube utilization
arm group type: Experimental
description: Aidcube is a fully customizable, commercially available digital "app"-based platform to deliver home-based pulmonary rehabilitation for patients. On the patient-facing side, patients can view their daily exercise prescription, descriptions and videos demonstrating correct execution of the exercises, document completion of exercises, and message their health-care provider. On the provider-facing side, from over 150 available exercises, surveys, and activities, providers can design a fully-customized exercise prescription. Based on real-time patient feedback, the exercise prescription can be progressed (i.e., advanced and/or modified) by adding repetitions or time to specific exercises or adding new activities. The provider can also message the patient from within the Aidcube environment.
intervention type: Other
intervention name: Aidcube digital app-based platform
description: Use of customizable, patient-specific mHealth home rehabilitation plan
arm group label: Aidcube utilization
criteria: 
gender: All
minimum age: 18 Years
maximum age: 76 Years
healthy volunteers: No
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Pennsylvania
investigator full name: Joshua M. Diamond MD,MSCE
investigator title: Assistant Professor of Medicine
sharing ipd: No