<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/NCT03034551</url>
  </required_header>
  <id_info>
    <org_study_id>W000002</org_study_id>
    <nct_id>NCT03034551</nct_id>
  </id_info>
  <brief_title>Mobile App With Patient Financial Incentives for Adherence to Heart Failure Medications &amp; Daily Self-Weighing</brief_title>
  <official_title>Randomized Controlled Trial of a Mobile App With Patient Financial Incentives for Tracking and Improving Adherence to Medications &amp; Daily Self-Weighing to Reduce Heart Failure Readmissions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wellth Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Princeton Healthcare System</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Wellth Inc.</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The goal of this study is to test the efficacy of a financial incentives-based telehealth&#xD;
      intervention to reduce 30- and 90-day heart failure (HF) readmissions by tracking and&#xD;
      increasing adherence to patient self-care - specifically by incentivizing adherence to&#xD;
      prescribed cardiac medication regimen and daily self-weighing. Patients randomized to the&#xD;
      treatment arm will be given a cellular-connected scale to use at home, as well as a mobile&#xD;
      app on their smartphone that tracks their adherence to daily self-weighing through the scale&#xD;
      and cardiac medications via patient photo submission. The health care team will intervene if&#xD;
      a sudden increase in weight is detected (2 lbs/day or 5 lbs/week). Financial incentives of&#xD;
      $150 are offered for full adherence over 90 days. Each day where the patient does not step on&#xD;
      the scale and complete a medication check-in will result in a deduction of $2 per day from&#xD;
      the incentive amount to be paid out. The control group will receive the usual discharge&#xD;
      instructions as prescribed by their health care team.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Nonadherence to cardiovascular medications and daily weight monitoring are critical issues in&#xD;
      readmissions to the hospital for heart failure. Only 60% of patients adhere to prescribed&#xD;
      cardiovascular medications on at least 80% of days, and only 40% monitor their weight daily,&#xD;
      despite owning scales. Nationally, nonadherence contributes to excessive HF readmission rates&#xD;
      of 50% within 6 months, and 24% within 30 days of discharge. To raise awareness and&#xD;
      accountability, the Centers for Medicare &amp; Medicaid Services (CMS) began reporting these&#xD;
      rates in 2009, and the Affordable Care Act and value-based contracts with payers have&#xD;
      established financial penalties to spur provider-based solutions.&#xD;
&#xD;
      Telehealth interventions are an ideal, low-cost, scalable method to reduce readmissions by&#xD;
      remotely enhancing patient support. Telehealth interventions for HF that target medication&#xD;
      compliance and self-weighing have demonstrated reductions in readmission rates by 80% or&#xD;
      more, but these are not yet widely adopted in clinical practice due to a lack of randomized,&#xD;
      controlled studies. We are thus proposing a randomized, controlled study of a proprietary&#xD;
      telehealth platform at University Medical Center of Princeton at Plainsboro (UMCPP) to enable&#xD;
      remote support for HF patients through a mobile app combined with financial incentives to&#xD;
      motivate adherence to medication and self-weighing. Patients admitted to UMCPP with the&#xD;
      primary admitting or discharge diagnosis of heart failure with reduced ejection fraction&#xD;
      (EF&lt;40%) (ICD-10 codes I50.2_) will be invited to participate in the study.&#xD;
&#xD;
      Each patient in the intervention arm will be offered $150 in incentives along with the Wellth&#xD;
      app loaded on to his or her smartphone. When users first log in to the app, which will occur&#xD;
      with the guidance of a healthcare provider trained in its use, they will be shown a large&#xD;
      dollar amount that they have earned by enrolling in the program - in this study $150 will be&#xD;
      offered for 90 days of perfect adherence to medications and daily self-weighing using&#xD;
      connected digital scales provided by Wellth. Instructions will also be given stating that&#xD;
      missed weight and medication check-ins will result in a $2 deduction per day from the account&#xD;
      to be paid out at each monthly pay period.&#xD;
&#xD;
      If a 2 lb. or greater daily increase in weight, or a 5 lb. weekly increase in weight, is&#xD;
      detected in any patient, a UMCPP physician or nurse will be alerted via automatic email and&#xD;
      text. A physician or a nurse will then call the patient to assess the patient's symptoms&#xD;
      (i.e. increasing shortness of breath or decreases in exertional tolerance, medication and&#xD;
      dietary adherence). Once a weight gain alert has been triggered, the team will continue to&#xD;
      receive additional data about the patient for the next 7 days to see if weight continues to&#xD;
      increase which would trigger an additional phone call and patient physician notification.&#xD;
&#xD;
      After a call is made to the patient, if, in the clinical judgment of the physician or nurse&#xD;
      that there are increasing heart failure symptoms, the physician or nurse will suggest to the&#xD;
      patient that they make an appointment and see their doctor within the next 48 hours.&#xD;
&#xD;
      Benefits of this study to the intervention arm include better health, reduced risk of&#xD;
      readmission, and concomitant reduction in healthcare burden, as well as a small but tangible&#xD;
      financial gain. Benefits for society, assuming widely applicable success, include reduction&#xD;
      in population-wide readmission rates due to greater health, and reduction in healthcare&#xD;
      spending.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Insufficient recruitment&#xD;
  </why_stopped>
  <start_date type="Actual">January 30, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2019</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>30-Day Cardiac Readmissions</measure>
    <time_frame>30 Days</time_frame>
    <description>Average rates of hospital readmissions within 30 days assessed by medical record review and patient interviews</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>90-Day Cardiac Readmissions</measure>
    <time_frame>90 Days</time_frame>
    <description>Average rates of hospital readmissions within 90 days assessed by medical record review and patient interviews</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adherence to Daily Medications</measure>
    <time_frame>90 Days</time_frame>
    <description>The percentage of days for which a patient submitted medication photos in the 90 days following discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adherence to Daily Self-Weighings</measure>
    <time_frame>90 Days</time_frame>
    <description>The percentage of days for which a patient completed a self-weighing using the provided cellular-connected scale in the 90 days following discharge</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Heart Failure</condition>
  <condition>Heart Failure, Congestive</condition>
  <condition>Heart Failure, Systolic</condition>
  <arm_group>
    <arm_group_label>Intervention Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects in the treatment arm will be offered a $150 incentive to use the Wellth app each day to log one daily self-weighing and one medication check-in. If a sudden jump in weight is detected among any subjects receiving the Financial Incentive, Mobile Phone App, and Cellular Scale, a UMCPP physician or nurse will then call the patient to assess the patient's symptoms (i.e. increasing shortness of breath or decreases in exertional tolerance, medication and dietary adherence).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care (Control) Arm</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients randomized to the standard of care arm will not receive the Wellth app or scale. They will have the usual discharge instructions as prescribed by their health care team.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Financial Incentive, Mobile Phone App, and Cellular Scale</intervention_name>
    <description>Subjects will be provided a cellular-connected digital scale and will be offered $150 to use the app each day to log one daily self-weighing and one medication check-in. Medication check-ins consist of uploading daily photos of pills at the time of self-administration through the Wellth app. If a 2 lb or greater daily increase in weight, or a 5 lb weekly increase in weight is detected in any patient, a UMCPP physician or nurse will be alerted via automatic email and text. A physician or a nurse will then call the patient to assess the patient's symptoms. If there are increasing heart failure symptoms, the physician or nurse will suggest the patient see their doctor within the next 48 hours and will notify the patient's primary care physician and cardiologist.</description>
    <arm_group_label>Intervention Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Admitted to or discharged from University Medical Center of Princeton at Plainsboro&#xD;
             (UMPCC) with the primary diagnosis of heart failure with reduced ejection fraction&#xD;
             (ICD-10 code I50.2x)&#xD;
&#xD;
          -  Standard of care medications for heart failure with reduced ejection fraction&#xD;
&#xD;
          -  Own a smart phone with a sufficient data plan or home Wi-Fi. Up to 30 phones can be&#xD;
             provided if needed.&#xD;
&#xD;
          -  Able to speak and understand either English or Spanish and able to learn the Wellth&#xD;
             app.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of HF following non-cardiac admission&#xD;
&#xD;
          -  Discharge to a care facility (anywhere that is not home)&#xD;
&#xD;
          -  Inability to step on a scale and steady oneself to obtain an accurate weight&#xD;
&#xD;
          -  Cognitive impairment or documented psychiatric illness that limits ability to&#xD;
             understand and respond to health-related questions&#xD;
&#xD;
          -  Inability to operate a mobile phone&#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>Stephen R Bergmann, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Princeton Healthcare System</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Medical Center of Princeton at Plainsboro</name>
      <address>
        <city>Plainsboro</city>
        <state>New Jersey</state>
        <zip>08536</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Ho PM, Bryson CL, Rumsfeld JS. Medication adherence: its importance in cardiovascular outcomes. Circulation. 2009 Jun 16;119(23):3028-35. doi: 10.1161/CIRCULATIONAHA.108.768986.</citation>
    <PMID>19528344</PMID>
  </reference>
  <reference>
    <citation>van der Wal MH, Jaarsma T, Moser DK, Veeger NJ, van Gilst WH, van Veldhuisen DJ. Compliance in heart failure patients: the importance of knowledge and beliefs. Eur Heart J. 2006 Feb;27(4):434-40. doi: 10.1093/eurheartj/ehi603. Epub 2005 Oct 17.</citation>
    <PMID>16230302</PMID>
  </reference>
  <reference>
    <citation>Desai AS, Stevenson LW. Rehospitalization for heart failure: predict or prevent? Circulation. 2012 Jul 24;126(4):501-6. doi: 10.1161/CIRCULATIONAHA.112.125435. No abstract available.</citation>
    <PMID>22825412</PMID>
  </reference>
  <reference>
    <citation>Maric B, Kaan A, Ignaszewski A, Lear SA. A systematic review of telemonitoring technologies in heart failure. Eur J Heart Fail. 2009 May;11(5):506-17. doi: 10.1093/eurjhf/hfp036. Epub 2009 Mar 29.</citation>
    <PMID>19332417</PMID>
  </reference>
  <reference>
    <citation>Maeng DD, Starr AE, Tomcavage JF, Sciandra J, Salek D, Griffith D. Can telemonitoring reduce hospitalization and cost of care? A health plan's experience in managing patients with heart failure. Popul Health Manag. 2014 Dec;17(6):340-4. doi: 10.1089/pop.2013.0107.</citation>
    <PMID>24865986</PMID>
  </reference>
  <reference>
    <citation>Haff N, Patel MS, Lim R, Zhu J, Troxel AB, Asch DA, Volpp KG. The role of behavioral economic incentive design and demographic characteristics in financial incentive-based approaches to changing health behaviors: a meta-analysis. Am J Health Promot. 2015 May-Jun;29(5):314-23. doi: 10.4278/ajhp.140714-LIT-333.</citation>
    <PMID>25928816</PMID>
  </reference>
  <reference>
    <citation>Chaudhry SI, Wang Y, Concato J, Gill TM, Krumholz HM. Patterns of weight change preceding hospitalization for heart failure. Circulation. 2007 Oct 2;116(14):1549-54. doi: 10.1161/CIRCULATIONAHA.107.690768. Epub 2007 Sep 10.</citation>
    <PMID>17846286</PMID>
  </reference>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>January 25, 2017</study_first_submitted>
  <study_first_submitted_qc>January 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 27, 2017</study_first_posted>
  <last_update_submitted>May 8, 2019</last_update_submitted>
  <last_update_submitted_qc>May 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 9, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Adherence</keyword>
  <keyword>Financial Incentives</keyword>
  <keyword>Remote Monitoring</keyword>
  <keyword>Self-Weighing</keyword>
  <keyword>Behavioral Economics</keyword>
  <keyword>Telehealth</keyword>
  <keyword>mobile health (mHealth)</keyword>
  <keyword>Smartphone App</keyword>
  <keyword>Wellth App</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
    <mesh_term>Heart Failure, Systolic</mesh_term>
    <mesh_term>Body Weight</mesh_term>
  </condition_browse>
  <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/NCT03034551
org study id: W000002
nct id: NCT03034551
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The goal of this study is to test the efficacy of a financial incentives-based telehealth
      intervention to reduce 30- and 90-day heart failure (HF) readmissions by tracking and
      increasing adherence to patient self-care - specifically by incentivizing adherence to
      prescribed cardiac medication regimen and daily self-weighing. Patients randomized to the
      treatment arm will be given a cellular-connected scale to use at home, as well as a mobile
      app on their smartphone that tracks their adherence to daily self-weighing through the scale
      and cardiac medications via patient photo submission. The health care team will intervene if
      a sudden increase in weight is detected (2 lbs/day or 5 lbs/week). Financial incentives of
      $150 are offered for full adherence over 90 days. Each day where the patient does not step on
      the scale and complete a medication check-in will result in a deduction of $2 per day from
      the incentive amount to be paid out. The control group will receive the usual discharge
      instructions as prescribed by their health care team.
Nonadherence to cardiovascular medications and daily weight monitoring are critical issues in
      readmissions to the hospital for heart failure. Only 60% of patients adhere to prescribed
      cardiovascular medications on at least 80% of days, and only 40% monitor their weight daily,
      despite owning scales. Nationally, nonadherence contributes to excessive HF readmission rates
      of 50% within 6 months, and 24% within 30 days of discharge. To raise awareness and
      accountability, the Centers for Medicare & Medicaid Services (CMS) began reporting these
      rates in 2009, and the Affordable Care Act and value-based contracts with payers have
      established financial penalties to spur provider-based solutions.

      Telehealth interventions are an ideal, low-cost, scalable method to reduce readmissions by
      remotely enhancing patient support. Telehealth interventions for HF that target medication
      compliance and self-weighing have demonstrated reductions in readmission rates by 80% or
      more, but these are not yet widely adopted in clinical practice due to a lack of randomized,
      controlled studies. We are thus proposing a randomized, controlled study of a proprietary
      telehealth platform at University Medical Center of Princeton at Plainsboro (UMCPP) to enable
      remote support for HF patients through a mobile app combined with financial incentives to
      motivate adherence to medication and self-weighing. Patients admitted to UMCPP with the
      primary admitting or discharge diagnosis of heart failure with reduced ejection fraction
      (EF<40%) (ICD-10 codes I50.2_) will be invited to participate in the study.

      Each patient in the intervention arm will be offered $150 in incentives along with the Wellth
      app loaded on to his or her smartphone. When users first log in to the app, which will occur
      with the guidance of a healthcare provider trained in its use, they will be shown a large
      dollar amount that they have earned by enrolling in the program - in this study $150 will be
      offered for 90 days of perfect adherence to medications and daily self-weighing using
      connected digital scales provided by Wellth. Instructions will also be given stating that
      missed weight and medication check-ins will result in a $2 deduction per day from the account
      to be paid out at each monthly pay period.

      If a 2 lb. or greater daily increase in weight, or a 5 lb. weekly increase in weight, is
      detected in any patient, a UMCPP physician or nurse will be alerted via automatic email and
      text. A physician or a nurse will then call the patient to assess the patient's symptoms
      (i.e. increasing shortness of breath or decreases in exertional tolerance, medication and
      dietary adherence). Once a weight gain alert has been triggered, the team will continue to
      receive additional data about the patient for the next 7 days to see if weight continues to
      increase which would trigger an additional phone call and patient physician notification.

      After a call is made to the patient, if, in the clinical judgment of the physician or nurse
      that there are increasing heart failure symptoms, the physician or nurse will suggest to the
      patient that they make an appointment and see their doctor within the next 48 hours.

      Benefits of this study to the intervention arm include better health, reduced risk of
      readmission, and concomitant reduction in healthcare burden, as well as a small but tangible
      financial gain. Benefits for society, assuming widely applicable success, include reduction
      in population-wide readmission rates due to greater health, and reduction in healthcare
      spending.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Investigator)
measure: 30-Day Cardiac Readmissions
time frame: 30 Days
description: Average rates of hospital readmissions within 30 days assessed by medical record review and patient interviews
measure: 90-Day Cardiac Readmissions
time frame: 90 Days
description: Average rates of hospital readmissions within 90 days assessed by medical record review and patient interviews
measure: Adherence to Daily Medications
time frame: 90 Days
description: The percentage of days for which a patient submitted medication photos in the 90 days following discharge
measure: Adherence to Daily Self-Weighings
time frame: 90 Days
description: The percentage of days for which a patient completed a self-weighing using the provided cellular-connected scale in the 90 days following discharge
arm group label: Intervention Arm
arm group type: Experimental
description: Subjects in the treatment arm will be offered a $150 incentive to use the Wellth app each day to log one daily self-weighing and one medication check-in. If a sudden jump in weight is detected among any subjects receiving the Financial Incentive, Mobile Phone App, and Cellular Scale, a UMCPP physician or nurse will then call the patient to assess the patient's symptoms (i.e. increasing shortness of breath or decreases in exertional tolerance, medication and dietary adherence).
arm group label: Standard of Care (Control) Arm
arm group type: No Intervention
description: Patients randomized to the standard of care arm will not receive the Wellth app or scale. They will have the usual discharge instructions as prescribed by their health care team.
intervention type: Behavioral
intervention name: Financial Incentive, Mobile Phone App, and Cellular Scale
description: Subjects will be provided a cellular-connected digital scale and will be offered $150 to use the app each day to log one daily self-weighing and one medication check-in. Medication check-ins consist of uploading daily photos of pills at the time of self-administration through the Wellth app. If a 2 lb or greater daily increase in weight, or a 5 lb weekly increase in weight is detected in any patient, a UMCPP physician or nurse will be alerted via automatic email and text. A physician or a nurse will then call the patient to assess the patient's symptoms. If there are increasing heart failure symptoms, the physician or nurse will suggest the patient see their doctor within the next 48 hours and will notify the patient's primary care physician and cardiologist.
arm group label: Intervention Arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Stephen R Bergmann, MD, PhD
role: Principal Investigator
affiliation: Princeton Healthcare System
facility: 
country: United States
citation: Ho PM, Bryson CL, Rumsfeld JS. Medication adherence: its importance in cardiovascular outcomes. Circulation. 2009 Jun 16;119(23):3028-35. doi: 10.1161/CIRCULATIONAHA.108.768986.
PMID: 19528344
citation: van der Wal MH, Jaarsma T, Moser DK, Veeger NJ, van Gilst WH, van Veldhuisen DJ. Compliance in heart failure patients: the importance of knowledge and beliefs. Eur Heart J. 2006 Feb;27(4):434-40. doi: 10.1093/eurheartj/ehi603. Epub 2005 Oct 17.
PMID: 16230302
citation: Desai AS, Stevenson LW. Rehospitalization for heart failure: predict or prevent? Circulation. 2012 Jul 24;126(4):501-6. doi: 10.1161/CIRCULATIONAHA.112.125435. No abstract available.
PMID: 22825412
citation: Maric B, Kaan A, Ignaszewski A, Lear SA. A systematic review of telemonitoring technologies in heart failure. Eur J Heart Fail. 2009 May;11(5):506-17. doi: 10.1093/eurjhf/hfp036. Epub 2009 Mar 29.
PMID: 19332417
citation: Maeng DD, Starr AE, Tomcavage JF, Sciandra J, Salek D, Griffith D. Can telemonitoring reduce hospitalization and cost of care? A health plan's experience in managing patients with heart failure. Popul Health Manag. 2014 Dec;17(6):340-4. doi: 10.1089/pop.2013.0107.
PMID: 24865986
citation: Haff N, Patel MS, Lim R, Zhu J, Troxel AB, Asch DA, Volpp KG. The role of behavioral economic incentive design and demographic characteristics in financial incentive-based approaches to changing health behaviors: a meta-analysis. Am J Health Promot. 2015 May-Jun;29(5):314-23. doi: 10.4278/ajhp.140714-LIT-333.
PMID: 25928816
citation: Chaudhry SI, Wang Y, Concato J, Gill TM, Krumholz HM. Patterns of weight change preceding hospitalization for heart failure. Circulation. 2007 Oct 2;116(14):1549-54. doi: 10.1161/CIRCULATIONAHA.107.690768. Epub 2007 Sep 10.
PMID: 17846286
responsible party type: Sponsor
mesh term: Heart Failure
mesh term: Heart Failure, Systolic
mesh term: Body Weight
sharing ipd: No