<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/NCT03234088</url>
  </required_header>
  <id_info>
    <org_study_id>RC2AG036592</org_study_id>
    <nct_id>NCT03234088</nct_id>
  </id_info>
  <brief_title>Congestive Heart Failure Pilot Study Utilizing Wireless Home Scale and Daily Symptom Monitoring</brief_title>
  <acronym>CHF</acronym>
  <official_title>Home Based Health Monitoring for Congestive Heart Failure Pilot</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pennsylvania</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Pennsylvania</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      As the population ages and medicine advances, there has been a significant shift to the&#xD;
      management of chronic diseases. Most chronic diseases are managed using evidence based&#xD;
      consensus guidelines but clinician and patient compliance with these guidelines is&#xD;
      sub-optimal. In addition, due to the nature of chronic diseases, patients need to make&#xD;
      long-term lifestyle changes in order to effectively control their disease in order to&#xD;
      minimize complications, disability and cost. It is these two factors, consistent&#xD;
      implementation of evidence-based guidelines and supporting patients in a way that encourages&#xD;
      self-management and lifestyle change, that disease management attempts to impact. There are&#xD;
      areas of design, implementation, testing and final-result-reporting to the patient and&#xD;
      clinician that require collaboration among information technology (IT) and software design&#xD;
      engineers and clinicians to achieve several goals:&#xD;
&#xD;
        1. Ensure patient safety.&#xD;
&#xD;
        2. Protect the security and integrity of clinical data.&#xD;
&#xD;
        3. Provide patient specific education to promote self-management.&#xD;
&#xD;
        4. Provide actionable data to clinicians in order to improve clinical care and minimize the&#xD;
           risk of adverse events.&#xD;
&#xD;
        5. Provide both patient and clinician satisfaction with the system of care.&#xD;
&#xD;
      In order to achieve these goals, testing and development of home technology under a&#xD;
      controlled clinical trial is critical.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will consist of: Specific Aim 1, Perform a pilot study to evaluate the initial&#xD;
      performance of the wireless scale and symptom monitoring system on a select number of&#xD;
      presumed normal volunteers (five). The purpose of this will be to determine design and&#xD;
      process changes prior to the use of the device in subjects with chronic heart failure (HF).&#xD;
      The investigators will have each normal volunteer (all part of the key research team) perform&#xD;
      scenarios to test the performance of the system. Specific Aim 2 will incorporate changes into&#xD;
      the prototype system adapting both the technology as well as the clinical workflows&#xD;
      surrounding its use based on the information collected in Specific Aim 1. Specific Aim 3 will&#xD;
      evaluate the revised system enrolling 40 volunteer subjects that have provided written&#xD;
      voluntary consent with the documented primary diagnosis of HF (systolic or diastolic) to&#xD;
      participate in the intervention over a 4-month period with the primary outcome measure being&#xD;
      reduction in HF related ER visit or hospitalization.&#xD;
&#xD;
      The objective of this study is to pilot test and refine a new home-based telemedicine health&#xD;
      monitoring system that provides wireless, low cost measurement of body weight as well as&#xD;
      self-reported responses, including symptoms and medication compliance for the purpose of&#xD;
      managing chronic heart failure (HF) within the home. This pilot will test the functionality&#xD;
      of the research infrastructure first on 5 healthy volunteers and then on 40 patients with&#xD;
      heart failure over 4 months, testing the receipt of accurate input from the wireless scale&#xD;
      and then assessing the effectiveness of the scale intervention in reducing ER visits and&#xD;
      hospitalizations.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2011</start_date>
  <completion_date type="Actual">August 2012</completion_date>
  <primary_completion_date type="Actual">August 2011</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>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Usage of home-health monitoring devices for weight</measure>
    <time_frame>Baseline through study completion, an average of four months</time_frame>
    <description>Monitoring daily weights and heart failure symptoms</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient and Provider Questionnaires on usability and functionality of the study's online web portal (Way to Health)</measure>
    <time_frame>Baseline through study completion, an average of four months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient and Provider Questionnaires on usability and functionality of the study's wifi-enabled home health monitoring devices</measure>
    <time_frame>Baseline through study completion, an average of four months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">13</enrollment>
  <condition>Congestive Heart Failure</condition>
  <arm_group>
    <arm_group_label>Home HF monitoring</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Digital scale readings are transmitted wirelessly to the handheld device. Patients will remotely log on to a secure server to answer daily symptom questions. Patients will complete surveys after voluntarily completing the informed consent process and at study closeout.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Daily weight measured by digital scale and symptom reporting</intervention_name>
    <description>All subjects will be provided the intervention.</description>
    <arm_group_label>Home HF monitoring</arm_group_label>
    <other_name>MedApps Healthcom wireless digital scale is being utilized</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Primary diagnosis of heart failure (either systolic or diastolic) NYHA class II, III&#xD;
             and IV&#xD;
&#xD;
          -  Physical and cognitive ability to use the device&#xD;
&#xD;
          -  Cellular phone or other portable device with &quot;text&quot; communication capability or daily&#xD;
             access to the internet using a computer or laptop&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject with life expectancy less than 6 months from any cause, or enrolled in hospice&#xD;
             care.&#xD;
&#xD;
          -  Subject not competent or unwilling to give voluntary informed consent.&#xD;
&#xD;
          -  Subject currently participating in another home telemedicine intervention trial&#xD;
&#xD;
          -  Subjects with a left ventricular assist device or who have had a cardiac transplant&#xD;
&#xD;
          -  Dialysis upon screening or creatinine &gt;2.5&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lee R Goldberg, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pennsylvania</affiliation>
  </overall_official>
  <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>
  <link>
    <url>http://www.ncbi.nlm.nih.gov/pubmed/18539982?dopt=AbstractPlus</url>
    <description>Caveat emptor: the need for evidence, regulation, and certification of home telehealth systems for the management of chronic conditions.</description>
  </link>
  <link>
    <url>http://www.ncbi.nlm.nih.gov/pubmed/14564327</url>
    <description>Randomized trial of a daily electronic home monitoring system in patients with advanced heart failure: the Weight Monitoring in Heart Failure (WHARF) trial.</description>
  </link>
  <link>
    <url>http://www.ncbi.nlm.nih.gov/pubmed/16911909</url>
    <description>Validation of prognostic models among patients with advanced heart failure.</description>
  </link>
  <link>
    <url>http://www.ncbi.nlm.nih.gov/pubmed/16004864</url>
    <description>Electronic and telemedicine techniques to manage heart failure.</description>
  </link>
  <link>
    <url>http://www.ncbi.nlm.nih.gov/pubmed/19782784</url>
    <description>Baseline differences in the HF-ACTION trial by sex.</description>
  </link>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>January 21, 2011</study_first_submitted>
  <study_first_submitted_qc>July 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2017</study_first_posted>
  <last_update_submitted>July 27, 2017</last_update_submitted>
  <last_update_submitted_qc>July 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 31, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Congestive Heart Failure</keyword>
  <keyword>Heart Failure</keyword>
  <keyword>Home telemonitoring</keyword>
  <keyword>Telehealth</keyword>
  <keyword>HF Disease Management</keyword>
  <keyword>Heart failure remote self management</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
  </condition_browse>
  <!-- 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/NCT03234088
org study id: RC2AG036592
nct id: NCT03234088
lead sponsor: 
has dmc: No
As the population ages and medicine advances, there has been a significant shift to the
      management of chronic diseases. Most chronic diseases are managed using evidence based
      consensus guidelines but clinician and patient compliance with these guidelines is
      sub-optimal. In addition, due to the nature of chronic diseases, patients need to make
      long-term lifestyle changes in order to effectively control their disease in order to
      minimize complications, disability and cost. It is these two factors, consistent
      implementation of evidence-based guidelines and supporting patients in a way that encourages
      self-management and lifestyle change, that disease management attempts to impact. There are
      areas of design, implementation, testing and final-result-reporting to the patient and
      clinician that require collaboration among information technology (IT) and software design
      engineers and clinicians to achieve several goals:

        1. Ensure patient safety.

        2. Protect the security and integrity of clinical data.

        3. Provide patient specific education to promote self-management.

        4. Provide actionable data to clinicians in order to improve clinical care and minimize the
           risk of adverse events.

        5. Provide both patient and clinician satisfaction with the system of care.

      In order to achieve these goals, testing and development of home technology under a
      controlled clinical trial is critical.
This study will consist of: Specific Aim 1, Perform a pilot study to evaluate the initial
      performance of the wireless scale and symptom monitoring system on a select number of
      presumed normal volunteers (five). The purpose of this will be to determine design and
      process changes prior to the use of the device in subjects with chronic heart failure (HF).
      The investigators will have each normal volunteer (all part of the key research team) perform
      scenarios to test the performance of the system. Specific Aim 2 will incorporate changes into
      the prototype system adapting both the technology as well as the clinical workflows
      surrounding its use based on the information collected in Specific Aim 1. Specific Aim 3 will
      evaluate the revised system enrolling 40 volunteer subjects that have provided written
      voluntary consent with the documented primary diagnosis of HF (systolic or diastolic) to
      participate in the intervention over a 4-month period with the primary outcome measure being
      reduction in HF related ER visit or hospitalization.

      The objective of this study is to pilot test and refine a new home-based telemedicine health
      monitoring system that provides wireless, low cost measurement of body weight as well as
      self-reported responses, including symptoms and medication compliance for the purpose of
      managing chronic heart failure (HF) within the home. This pilot will test the functionality
      of the research infrastructure first on 5 healthy volunteers and then on 40 patients with
      heart failure over 4 months, testing the receipt of accurate input from the wireless scale
      and then assessing the effectiveness of the scale intervention in reducing ER visits and
      hospitalizations.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Usage of home-health monitoring devices for weight
time frame: Baseline through study completion, an average of four months
description: Monitoring daily weights and heart failure symptoms
measure: Patient and Provider Questionnaires on usability and functionality of the study's online web portal (Way to Health)
time frame: Baseline through study completion, an average of four months
measure: Patient and Provider Questionnaires on usability and functionality of the study's wifi-enabled home health monitoring devices
time frame: Baseline through study completion, an average of four months
arm group label: Home HF monitoring
arm group type: Other
description: Digital scale readings are transmitted wirelessly to the handheld device. Patients will remotely log on to a secure server to answer daily symptom questions. Patients will complete surveys after voluntarily completing the informed consent process and at study closeout.
intervention type: Behavioral
intervention name: Daily weight measured by digital scale and symptom reporting
description: All subjects will be provided the intervention.
arm group label: Home HF monitoring
other name: MedApps Healthcom wireless digital scale is being utilized
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lee R Goldberg, MD, MPH
role: Principal Investigator
affiliation: University of Pennsylvania
facility: 
country: United States
url: http://www.ncbi.nlm.nih.gov/pubmed/18539982?dopt=AbstractPlus
description: Caveat emptor: the need for evidence, regulation, and certification of home telehealth systems for the management of chronic conditions.
url: http://www.ncbi.nlm.nih.gov/pubmed/14564327
description: Randomized trial of a daily electronic home monitoring system in patients with advanced heart failure: the Weight Monitoring in Heart Failure (WHARF) trial.
url: http://www.ncbi.nlm.nih.gov/pubmed/16911909
description: Validation of prognostic models among patients with advanced heart failure.
url: http://www.ncbi.nlm.nih.gov/pubmed/16004864
description: Electronic and telemedicine techniques to manage heart failure.
url: http://www.ncbi.nlm.nih.gov/pubmed/19782784
description: Baseline differences in the HF-ACTION trial by sex.
responsible party type: Sponsor
mesh term: Heart Failure