<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/NCT03238729</url>
  </required_header>
  <id_info>
    <org_study_id>CHF-MGH-001</org_study_id>
    <nct_id>NCT03238729</nct_id>
  </id_info>
  <brief_title>Proof-of-Concept Study of Heart Habits Application for Patients With Heart Failure</brief_title>
  <official_title>Proof-of-Concept Study of a Smartphone Application Created to Improve Management of Ambulatory Patients With Heart Failure: the Heart Failure Heart Habits Application</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jana Care</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Jana Care</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>
      This study assesses the ability of ambulatory patients with heart failure (HF) to use a&#xD;
      smartphone application created for the management of patients with chronic HF. This study&#xD;
      will aim:&#xD;
&#xD;
        -  To understand the frequency with which ambulatory HF patients engage with this&#xD;
           smartphone application.&#xD;
&#xD;
        -  To determine whether patient's knowledge of HF and its management has improved with the&#xD;
           use of this smartphone application.&#xD;
&#xD;
        -  To assess improvement in quality of life measures related to the use of this smartphone&#xD;
           application.&#xD;
&#xD;
        -  To assess improvement in lifestyle measures related to the use of this smartphone&#xD;
           application.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 21, 2017</start_date>
  <completion_date type="Actual">March 5, 2018</completion_date>
  <primary_completion_date type="Actual">March 5, 2018</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patients that complete the curriculum</measure>
    <time_frame>6 weeks</time_frame>
    <description>Total number of patients who complete the lessons on the app</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Frequency of app use</measure>
    <time_frame>6 weeks</time_frame>
    <description>Measuring how often and how long patients engaged with the app</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Score on Atlanta HF Knowledge Test</measure>
    <time_frame>6 weeks</time_frame>
    <description>Assess patients knowledge of heart failure before and after study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Score on Kansas City Cardiomyopathy Questionnaire-12</measure>
    <time_frame>6 weeks</time_frame>
    <description>Assess changes in patients self-reported quality of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>%change in weekly activity as measured by steps</measure>
    <time_frame>6 weeks</time_frame>
    <description>Assess changes in lifestyle measures (diet, activity, etc.)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self reported frequency of weight measurement, exercise, fluid tracking, and sodium tracking</measure>
    <time_frame>6 weeks</time_frame>
    <description>Compare baseline to end of study on a questionnaire</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>Heart Failure</condition>
  <arm_group>
    <arm_group_label>CHF App</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will be provided with a mobile app on a smartphone for education and management of heart failure.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will be provided standard literature on heart failure management.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Heart Failure Education and Management App</intervention_name>
    <description>Patients will be provided with an app on a smartphone that provides a daily checklist with items like reminders for logging weight and food, as well as educational components about heart failure and it's management.</description>
    <arm_group_label>CHF App</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Heart Failure Literature</intervention_name>
    <description>Patients will be provided standard literature about heart failure and the management of heart failure.</description>
    <arm_group_label>Standard of Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of HFrEF or HFpEF. HFrEF defined as clinical signs and symptoms of HF with a&#xD;
             left ventricular (LV) EF ≤ 40% by any imaging modality AND at least 1 hospitalization&#xD;
             or emergency department (ED) visit for HF or any outpatient escalation of diuretic&#xD;
             therapy in the 12 months prior to study enrollment. HFpEF defined as clinical signs&#xD;
             and symptoms of HF with an LVEF ≥ 50% by any imaging modality and at least 1&#xD;
             hospitalization or ED visit for HF or any outpatient escalation of diuretic therapy in&#xD;
             the 12 months prior to study enrollment.&#xD;
&#xD;
          -  Adult patients, men and women, &gt; 18 years old.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant&#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>Hanna K Gaggin, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Nasrien E Ibrahim, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Go AS, Mozaffarian D, Roger VL, Benjamin EJ, Berry JD, Blaha MJ, Dai S, Ford ES, Fox CS, Franco S, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Huffman MD, Judd SE, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Mackey RH, Magid DJ, Marcus GM, Marelli A, Matchar DB, McGuire DK, Mohler ER 3rd, Moy CS, Mussolino ME, Neumar RW, Nichol G, Pandey DK, Paynter NP, Reeves MJ, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Wong ND, Woo D, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2014 update: a report from the American Heart Association. Circulation. 2014 Jan 21;129(3):e28-e292. doi: 10.1161/01.cir.0000441139.02102.80. Epub 2013 Dec 18. No abstract available.</citation>
    <PMID>24352519</PMID>
  </reference>
  <reference>
    <citation>Konstam MA. Home monitoring should be the central element in an effective program of heart failure disease management. Circulation. 2012 Feb 14;125(6):820-7. doi: 10.1161/CIRCULATIONAHA.111.031161. No abstract available.</citation>
    <PMID>22331919</PMID>
  </reference>
  <reference>
    <citation>Gardetto NJ. Self-management in heart failure: where have we been and where should we go? J Multidiscip Healthc. 2011 Mar 31;4:39-51. doi: 10.2147/JMDH.S8174.</citation>
    <PMID>21544247</PMID>
  </reference>
  <reference>
    <citation>Powell LH, Calvin JE Jr, Richardson D, Janssen I, Mendes de Leon CF, Flynn KJ, Grady KL, Rucker-Whitaker CS, Eaton C, Avery E; HART Investigators. Self-management counseling in patients with heart failure: the heart failure adherence and retention randomized behavioral trial. JAMA. 2010 Sep 22;304(12):1331-8. doi: 10.1001/jama.2010.1362.</citation>
    <PMID>20858878</PMID>
  </reference>
  <reference>
    <citation>Shaw JD, O'Neal DJ 3rd, Siddharthan K, Neugaard BI. Pilot program to improve self-management of patients with heart failure by redesigning care coordination. Nurs Res Pract. 2014;2014:836921. doi: 10.1155/2014/836921. Epub 2014 Apr 23.</citation>
    <PMID>24864206</PMID>
  </reference>
  <reference>
    <citation>White MF, Kirschner J, Hamilton MA. Self-care guide for the heart failure patient. Circulation. 2014 Jan 21;129(3):e293-4. doi: 10.1161/CIRCULATIONAHA.113.003991. No abstract available.</citation>
    <PMID>24446413</PMID>
  </reference>
  <reference>
    <citation>Sochalski J, Jaarsma T, Krumholz HM, Laramee A, McMurray JJ, Naylor MD, Rich MW, Riegel B, Stewart S. What works in chronic care management: the case of heart failure. Health Aff (Millwood). 2009 Jan-Feb;28(1):179-89. doi: 10.1377/hlthaff.28.1.179.</citation>
    <PMID>19124869</PMID>
  </reference>
  <reference>
    <citation>Bonin CD, Santos RZ, Ghisi GL, Vieira AM, Amboni R, Benetti M. Construction and validation of a questionnaire about heart failure patients' knowledge of their disease. Arq Bras Cardiol. 2014 Apr;102(4):364-73. doi: 10.5935/abc.20140032. Epub 2014 Feb 17.</citation>
    <PMID>24652054</PMID>
  </reference>
  <reference>
    <citation>Masterson Creber RM, Maurer MS, Reading M, Hiraldo G, Hickey KT, Iribarren S. Review and Analysis of Existing Mobile Phone Apps to Support Heart Failure Symptom Monitoring and Self-Care Management Using the Mobile Application Rating Scale (MARS). JMIR Mhealth Uhealth. 2016 Jun 14;4(2):e74. doi: 10.2196/mhealth.5882.</citation>
    <PMID>27302310</PMID>
  </reference>
  <reference>
    <citation>Yancy CW, Jessup M, Bozkurt B, Butler J, Casey DE Jr, Drazner MH, Fonarow GC, Geraci SA, Horwich T, Januzzi JL, Johnson MR, Kasper EK, Levy WC, Masoudi FA, McBride PE, McMurray JJ, Mitchell JE, Peterson PN, Riegel B, Sam F, Stevenson LW, Tang WH, Tsai EJ, Wilkoff BL. 2013 ACCF/AHA guideline for the management of heart failure: executive summary: a report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines. Circulation. 2013 Oct 15;128(16):1810-52. doi: 10.1161/CIR.0b013e31829e8807. Epub 2013 Jun 5. No abstract available.</citation>
    <PMID>23741057</PMID>
  </reference>
  <reference>
    <citation>WRITING COMMITTEE MEMBERS; ACC/AHA TASK FORCE MEMBERS. 2016 ACC/AHA/HFSA Focused Update on New Pharmacological Therapy for Heart Failure: An Update of the 2013 ACCF/AHA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Failure Society of America. J Card Fail. 2016 Sep;22(9):659-69. doi: 10.1016/j.cardfail.2016.07.001. Epub 2016 Jul 6. No abstract available.</citation>
    <PMID>27394189</PMID>
  </reference>
  <reference>
    <citation>Spertus JA, Jones PG. Development and Validation of a Short Version of the Kansas City Cardiomyopathy Questionnaire. Circ Cardiovasc Qual Outcomes. 2015 Sep;8(5):469-76. doi: 10.1161/CIRCOUTCOMES.115.001958.</citation>
    <PMID>26307129</PMID>
  </reference>
  <reference>
    <citation>Vieira AM, Costa IZ, Oh P, Lima de Melo Ghisi G. Questionnaires Designed to Assess Knowledge of Heart Failure Patients: A Systematic Review. J Cardiovasc Nurs. 2016 Sep-Oct;31(5):469-78. doi: 10.1097/JCN.0000000000000281.</citation>
    <PMID>26208265</PMID>
  </reference>
  <reference>
    <citation>Reilly CM, Higgins M, Smith A, Gary RA, Robinson J, Clark PC, McCarty F, Dunbar SB. Development, psychometric testing, and revision of the Atlanta Heart Failure Knowledge Test. J Cardiovasc Nurs. 2009 Nov-Dec;24(6):500-9. doi: 10.1097/JCN.0b013e3181aff0b0.</citation>
    <PMID>19858959</PMID>
  </reference>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>July 28, 2017</study_first_submitted>
  <study_first_submitted_qc>July 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2017</study_first_posted>
  <last_update_submitted>May 8, 2018</last_update_submitted>
  <last_update_submitted_qc>May 8, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 9, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</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/NCT03238729
org study id: CHF-MGH-001
nct id: NCT03238729
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study assesses the ability of ambulatory patients with heart failure (HF) to use a
      smartphone application created for the management of patients with chronic HF. This study
      will aim:

        -  To understand the frequency with which ambulatory HF patients engage with this
           smartphone application.

        -  To determine whether patient's knowledge of HF and its management has improved with the
           use of this smartphone application.

        -  To assess improvement in quality of life measures related to the use of this smartphone
           application.

        -  To assess improvement in lifestyle measures related to the use of this smartphone
           application.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Number of patients that complete the curriculum
time frame: 6 weeks
description: Total number of patients who complete the lessons on the app
measure: Frequency of app use
time frame: 6 weeks
description: Measuring how often and how long patients engaged with the app
measure: Score on Atlanta HF Knowledge Test
time frame: 6 weeks
description: Assess patients knowledge of heart failure before and after study
measure: Score on Kansas City Cardiomyopathy Questionnaire-12
time frame: 6 weeks
description: Assess changes in patients self-reported quality of life
measure: %change in weekly activity as measured by steps
time frame: 6 weeks
description: Assess changes in lifestyle measures (diet, activity, etc.)
measure: Self reported frequency of weight measurement, exercise, fluid tracking, and sodium tracking
time frame: 6 weeks
description: Compare baseline to end of study on a questionnaire
arm group label: CHF App
arm group type: Experimental
description: Patients will be provided with a mobile app on a smartphone for education and management of heart failure.
arm group label: Standard of Care
arm group type: Active Comparator
description: Patients will be provided standard literature on heart failure management.
intervention type: Behavioral
intervention name: Heart Failure Education and Management App
description: Patients will be provided with an app on a smartphone that provides a daily checklist with items like reminders for logging weight and food, as well as educational components about heart failure and it's management.
arm group label: CHF App
intervention type: Behavioral
intervention name: Heart Failure Literature
description: Patients will be provided standard literature about heart failure and the management of heart failure.
arm group label: Standard of Care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Hanna K Gaggin, MD, MPH
role: Principal Investigator
affiliation: Massachusetts General Hospital
last name: Nasrien E Ibrahim, MD
role: Principal Investigator
affiliation: Massachusetts General Hospital
facility: 
country: United States
citation: Go AS, Mozaffarian D, Roger VL, Benjamin EJ, Berry JD, Blaha MJ, Dai S, Ford ES, Fox CS, Franco S, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Huffman MD, Judd SE, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Mackey RH, Magid DJ, Marcus GM, Marelli A, Matchar DB, McGuire DK, Mohler ER 3rd, Moy CS, Mussolino ME, Neumar RW, Nichol G, Pandey DK, Paynter NP, Reeves MJ, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Wong ND, Woo D, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2014 update: a report from the American Heart Association. Circulation. 2014 Jan 21;129(3):e28-e292. doi: 10.1161/01.cir.0000441139.02102.80. Epub 2013 Dec 18. No abstract available.
PMID: 24352519
citation: Konstam MA. Home monitoring should be the central element in an effective program of heart failure disease management. Circulation. 2012 Feb 14;125(6):820-7. doi: 10.1161/CIRCULATIONAHA.111.031161. No abstract available.
PMID: 22331919
citation: Gardetto NJ. Self-management in heart failure: where have we been and where should we go? J Multidiscip Healthc. 2011 Mar 31;4:39-51. doi: 10.2147/JMDH.S8174.
PMID: 21544247
citation: Powell LH, Calvin JE Jr, Richardson D, Janssen I, Mendes de Leon CF, Flynn KJ, Grady KL, Rucker-Whitaker CS, Eaton C, Avery E; HART Investigators. Self-management counseling in patients with heart failure: the heart failure adherence and retention randomized behavioral trial. JAMA. 2010 Sep 22;304(12):1331-8. doi: 10.1001/jama.2010.1362.
PMID: 20858878
citation: Shaw JD, O'Neal DJ 3rd, Siddharthan K, Neugaard BI. Pilot program to improve self-management of patients with heart failure by redesigning care coordination. Nurs Res Pract. 2014;2014:836921. doi: 10.1155/2014/836921. Epub 2014 Apr 23.
PMID: 24864206
citation: White MF, Kirschner J, Hamilton MA. Self-care guide for the heart failure patient. Circulation. 2014 Jan 21;129(3):e293-4. doi: 10.1161/CIRCULATIONAHA.113.003991. No abstract available.
PMID: 24446413
citation: Sochalski J, Jaarsma T, Krumholz HM, Laramee A, McMurray JJ, Naylor MD, Rich MW, Riegel B, Stewart S. What works in chronic care management: the case of heart failure. Health Aff (Millwood). 2009 Jan-Feb;28(1):179-89. doi: 10.1377/hlthaff.28.1.179.
PMID: 19124869
citation: Bonin CD, Santos RZ, Ghisi GL, Vieira AM, Amboni R, Benetti M. Construction and validation of a questionnaire about heart failure patients' knowledge of their disease. Arq Bras Cardiol. 2014 Apr;102(4):364-73. doi: 10.5935/abc.20140032. Epub 2014 Feb 17.
PMID: 24652054
citation: Masterson Creber RM, Maurer MS, Reading M, Hiraldo G, Hickey KT, Iribarren S. Review and Analysis of Existing Mobile Phone Apps to Support Heart Failure Symptom Monitoring and Self-Care Management Using the Mobile Application Rating Scale (MARS). JMIR Mhealth Uhealth. 2016 Jun 14;4(2):e74. doi: 10.2196/mhealth.5882.
PMID: 27302310
citation: Yancy CW, Jessup M, Bozkurt B, Butler J, Casey DE Jr, Drazner MH, Fonarow GC, Geraci SA, Horwich T, Januzzi JL, Johnson MR, Kasper EK, Levy WC, Masoudi FA, McBride PE, McMurray JJ, Mitchell JE, Peterson PN, Riegel B, Sam F, Stevenson LW, Tang WH, Tsai EJ, Wilkoff BL. 2013 ACCF/AHA guideline for the management of heart failure: executive summary: a report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines. Circulation. 2013 Oct 15;128(16):1810-52. doi: 10.1161/CIR.0b013e31829e8807. Epub 2013 Jun 5. No abstract available.
PMID: 23741057
citation: WRITING COMMITTEE MEMBERS; ACC/AHA TASK FORCE MEMBERS. 2016 ACC/AHA/HFSA Focused Update on New Pharmacological Therapy for Heart Failure: An Update of the 2013 ACCF/AHA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Failure Society of America. J Card Fail. 2016 Sep;22(9):659-69. doi: 10.1016/j.cardfail.2016.07.001. Epub 2016 Jul 6. No abstract available.
PMID: 27394189
citation: Spertus JA, Jones PG. Development and Validation of a Short Version of the Kansas City Cardiomyopathy Questionnaire. Circ Cardiovasc Qual Outcomes. 2015 Sep;8(5):469-76. doi: 10.1161/CIRCOUTCOMES.115.001958.
PMID: 26307129
citation: Vieira AM, Costa IZ, Oh P, Lima de Melo Ghisi G. Questionnaires Designed to Assess Knowledge of Heart Failure Patients: A Systematic Review. J Cardiovasc Nurs. 2016 Sep-Oct;31(5):469-78. doi: 10.1097/JCN.0000000000000281.
PMID: 26208265
citation: Reilly CM, Higgins M, Smith A, Gary RA, Robinson J, Clark PC, McCarty F, Dunbar SB. Development, psychometric testing, and revision of the Atlanta Heart Failure Knowledge Test. J Cardiovasc Nurs. 2009 Nov-Dec;24(6):500-9. doi: 10.1097/JCN.0b013e3181aff0b0.
PMID: 19858959
responsible party type: Sponsor
mesh term: Heart Failure
sharing ipd: No