<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/NCT04426630</url>
  </required_header>
  <id_info>
    <org_study_id>2000025338</org_study_id>
    <secondary_id>1R21TW010998-01A1</secondary_id>
    <nct_id>NCT04426630</nct_id>
  </id_info>
  <brief_title>mHealth for Self-care of Heart Failure in Uganda</brief_title>
  <official_title>An Accessible, Scalable, Patient-facing mHealth Application for Self-care of Heart Failure in LMIC</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fogarty International Center of the National Institute of Health</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Makerere University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Uganda Heart Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Health Network, Toronto</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Yale University</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>
      Heart failure affects more than 38 million people globally. It is responsible for high rates&#xD;
      of hospitalization and premature mortality, especially in sub-Saharan Africa. Heart failure&#xD;
      causes multiple debilitating and distressing symptoms. These symptoms can often be managed by&#xD;
      patients themselves but only when they are able to identify symptoms and select appropriate&#xD;
      actions. Self-care, a World Health Organization-endorsed intervention for chronic conditions&#xD;
      like heart failure, is greatly underutilized in lower and middle income countries, including&#xD;
      Uganda. Self-care refers to the ability of patients, caregivers and communities to maintain&#xD;
      health, prevent disease, and manage illness, with or without a healthcare provider. Mobile&#xD;
      health (mHealth) offers a promising platform to address this need gap in lower and middle&#xD;
      income countries. mHealth takes advantage of the widespread usage of mobile phones to offer&#xD;
      patients individualized self-care tools such as education, healthy lifestyle prompts, and&#xD;
      support with making decisions. Since 2016, this multidisciplinary, international research&#xD;
      team has been designing Medly Uganda, an mHealth application to improve self-care among&#xD;
      Ugandan patients with heart failure. This application began as a smartphone but was adapted&#xD;
      for the low-cost feature phones used widely throughout the country. It was also integrated&#xD;
      into an mHealth system endorsed by the Ugandan Ministry of Health. When patients log in they&#xD;
      are prompted to report on specific heart failure symptoms. The application then generates&#xD;
      self-care instructions based on those symptoms. If a patient reports serious symptoms the&#xD;
      application triggers an alert to the research nurse, who then consults with the patient,&#xD;
      caregiver, and if needed, cardiologist, to establish a plan of care. This study proposes that&#xD;
      an mHealth intervention tailored specifically to the local context will improve healthcare&#xD;
      quality of life for patients with heart failure. The research team hypothesizes that heart&#xD;
      failure patients who use the program will report improved scores on the Self-Care in Heart&#xD;
      Failure Index. These scores will be assessed at baseline, three-month, and six-month visits.&#xD;
      The researchers will also measure changes in patients' clinical conditions, including the&#xD;
      6-minute walk test, left ventricular ejection fraction, and frequency of acute care visits.&#xD;
      Finally, the researchers will conduct qualitative interviews with patients and providers to&#xD;
      understand their experiences.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants will be asked to initiate self-care sessions using the Medly Uganda application.&#xD;
      They will dial the sub-code and enter a unique PIN to access the system. They are asked to do&#xD;
      this every Monday, Wednesday, and Friday morning for six months, as well as anytime that they&#xD;
      experience concerning symptoms. If a participant has not initiated a session by 11:00am on&#xD;
      the designated days, the application will generate an SMS reminder. Each interactive session&#xD;
      will present a series of symptom-based questions to the participant. These questions will be&#xD;
      followed by a tailored SMS message. While session content will not remain on the&#xD;
      participant's phone, the SMS messages will. This allows participants to retain and review&#xD;
      messages, thereby reinforcing educational content. There are four status categories: Stable,&#xD;
      Fluid Overload, Urgent, and Critical. If Stable, participants will be sent one of six&#xD;
      encouraging and educational messages. If Fluid Overload, Urgent or Critical, patient&#xD;
      participants will be sent a message that identifies the symptom and recommends an action and&#xD;
      the on-duty nurse will be sent an accompanying alert. Urgent and Critical alerts will also be&#xD;
      sent to the on-duty doctor. The nurse is expected to call the patient for Urgent and Critical&#xD;
      alerts within 60 and 15 minutes, respectively. Nurse phone call interactions will be guided&#xD;
      by a standard operating manual. One nurse and one doctor will be designated rotating&#xD;
      'on-duty' responsibility to monitor clinician alerts and the dashboard seven days a week. The&#xD;
      doctor will be available to provide clinical supervision to the nurse as needed and they will&#xD;
      have a daily in-person or by-phone.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 19, 2020</start_date>
  <completion_date type="Actual">September 6, 2021</completion_date>
  <primary_completion_date type="Actual">September 6, 2021</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>This is a single-center prospective cohort study. The researchers will use consecutive sampling to identify potential patient participants.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Self-Care for Heart Failure Index, Maintenance</measure>
    <time_frame>Baseline and Six-month follow-up</time_frame>
    <description>The Self-care of Heart Failure Index (SCHFI) is a measure of self-care defined as a naturalistic decision-making process involving the choice of behaviors that maintain physiological stability (maintenance), the response to symptoms when they occur (management), and confidence in self-care (confidence). The self-care maintenance subscale includes 10 items asking how often patients check their heart failure symptoms and treatment adherence. The score is standardized to a 0- to 100-point range: raw score sum minus lowest possible raw scale score, then divided by the possible range of scores, and finally multiplied by 100. Higher score for each scale indicates better self-maintenance.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Self-Care for Heart Failure Index, Management</measure>
    <time_frame>Baseline and Six-month follow-up</time_frame>
    <description>The Self-care of Heart Failure Index (SCHFI) is a measure of self-care defined as a naturalistic decision-making process involving the choice of behaviors that maintain physiological stability (maintenance), the response to symptoms when they occur (management), and confidence in self-care (confidence). The self-care management subscale includes 6 items if patients report any heart failure symptoms in the past month. Then based on the responses on how quick they recognize it as a symptom of heart failure and remedies they tried, the score is standardized to a 0- to 100-point range: raw score sum minus lowest possible raw scale score, then divided by the possible range of scores, and finally multiplied by 100. Higher score for each scale indicates better self-management.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Self-Care for Heart Failure Index, Confidence</measure>
    <time_frame>Baseline and Six-month follow-up</time_frame>
    <description>The Self-care of Heart Failure Index (SCHFI) is a measure of self-care defined as a naturalistic decision-making process involving the choice of behaviors that maintain physiological stability (maintenance), the response to symptoms when they occur (management), and confidence in self-care (confidence). The self-care confidence subscale includes 6 items asking how confident that they can keep themselves free of symptoms, follow treatment advice, recognize changes in their health and etc.. The score is standardized to a 0- to 100-point range: raw score sum minus lowest possible raw scale score, then divided by the possible range of scores, and finally multiplied by 100. Higher score for each scale indicates better self-confidence</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>EQ-5D-5L, Mobility</measure>
    <time_frame>Baseline and Six-month follow-up visit</time_frame>
    <description>Measure Description: Healthcare quality of life will be measured using the 5-level EQ-5D version (EQ-5D-5L). It is a validated instrument appropriate for use in lower and middle income countries. Each of the five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) comprises the EQ-5D descriptive system. We regrouped the 5 levels of perceived problems into binary responses as &quot;no problem&quot; (Level 1), or &quot;Having problems&quot; (Level 2-5).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EQ-5D-5L, Self-Care</measure>
    <time_frame>Baseline and Six-month follow-up visit</time_frame>
    <description>Measure Description: Healthcare quality of life will be measured using the 5-level EQ-5D version (EQ-5D-5L). It is a validated instrument appropriate for use in lower and middle income countries. Each of the five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) comprises the EQ-5D descriptive system. We regrouped the 5 levels of perceived problems into binary responses as &quot;no problem&quot; (Level 1), or &quot;Having problems&quot; (Level 2-5).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EQ-5D-5L, Usual Activities</measure>
    <time_frame>Baseline and Six-month follow-up visit</time_frame>
    <description>Measure Description: Healthcare quality of life will be measured using the 5-level EQ-5D version (EQ-5D-5L). It is a validated instrument appropriate for use in lower and middle income countries. Each of the five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) comprises the EQ-5D descriptive system. We regrouped the 5 levels of perceived problems into binary responses as &quot;no problem&quot; (Level 1), or &quot;Having problems&quot; (Level 2-5).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EQ-5D-5L, Pain or Discomfort</measure>
    <time_frame>Baseline and Six-month follow-up visit</time_frame>
    <description>Measure Description: Healthcare quality of life will be measured using the 5-level EQ-5D version (EQ-5D-5L). It is a validated instrument appropriate for use in lower and middle income countries. Each of the five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) comprises the EQ-5D descriptive system. We regrouped the 5 levels of perceived problems into binary responses as &quot;no problem&quot; (Level 1), or &quot;Having problems&quot; (Level 2-5).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EQ-5D-5L, Anxiety or Depression</measure>
    <time_frame>Baseline and Six-month follow-up visit</time_frame>
    <description>Measure Description: Healthcare quality of life will be measured using the 5-level EQ-5D version (EQ-5D-5L). It is a validated instrument appropriate for use in lower and middle income countries. Each of the five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) comprises the EQ-5D descriptive system. We regrouped the 5 levels of perceived problems into binary responses as &quot;no problem&quot; (Level 1), or &quot;Having problems&quot; (Level 2-5).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EQ-5D-5L, VAS</measure>
    <time_frame>Baseline and Six-month follow-up visit</time_frame>
    <description>The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the 100 indicates 'The best health you can imagine' and 0 means 'The worst health you can imagine'.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Six-Minute Walk Test, Total Distance</measure>
    <time_frame>Baseline and Six-month follow-up visit</time_frame>
    <description>Patients' functional capacity will be assessed using the Six-Minute Walk Test, a widely-used, reproducible exercise test that serves as a strong predictor of morbidity and mortality in heart failure patients. Outcome is measured as a distance in meters. Possible range is 0-700m. Healthy range is considered 400-700m but may not be normative for all populations, including people with chronic diseases. In this study difference in distance (meters) will be examined across visits, with a lower score reflecting worse function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Left Ventricular Ejection Fraction</measure>
    <time_frame>Baseline and Six-month follow-up visit</time_frame>
    <description>Left ventricular ejection fraction (LVEF) is a widely-recognized clinical prognostic marker for heart failure patients. It is measured as a percentage. Possible range is 0-100. Low is &lt;50%. High is &gt;=50%. LVEF is measured by echocardiogram using Simpson biplane formula</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of Acute Care Visits</measure>
    <time_frame>Baseline and Six-month follow-up visit</time_frame>
    <description>Patients will be asked to report how often they required acute care for their heart failure outside of their usual care. This outcome is the frequency of acute care visits as categorical variable: 0, 1 and ≥2. Possible range is 0-31.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">72</enrollment>
  <condition>Heart Failure</condition>
  <arm_group>
    <arm_group_label>mHealth</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Heart failure patients enrolled in the mHealth program</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>mHealth for heart failure patients in Uganda</intervention_name>
    <description>Patients at Uganda Heart Institute will be enrolled in an mHealth program intended to promote self-care for heart failure and improve their healthcare quality of life.</description>
    <arm_group_label>mHealth</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  UHI patient presenting for routine or urgent outpatient visit&#xD;
&#xD;
          -  Currently living in Uganda and not planning to travel abroad for six months&#xD;
&#xD;
          -  Age &gt;=18 years&#xD;
&#xD;
          -  Symptomatic heart failure (New York Heart Association Class II or III and left&#xD;
             ventricular ejection fraction of 45% or less)&#xD;
&#xD;
          -  Access to a mobile phone&#xD;
&#xD;
          -  Basic reading skills in English, Luganda, and/or Runyankole&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Life expectancy &lt; six months&#xD;
&#xD;
          -  Active medical condition requiring hospitalization, such as cardiac ischemia (acute&#xD;
             electrocardiographic changes and/or positive biomarkers, if available), syncope, or&#xD;
             significant fluid overload&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Inability to provide informed consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jeremy Schwartz, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yale University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Isaac Ssinabulya, MMed</last_name>
    <role>Principal Investigator</role>
    <affiliation>Uganda Heart Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Uganda Heart Institute</name>
      <address>
        <city>Kampala</city>
        <country>Uganda</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Uganda</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>June 8, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <results_first_submitted>May 31, 2022</results_first_submitted>
  <results_first_submitted_qc>July 15, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">August 10, 2022</results_first_posted>
  <last_update_submitted>December 5, 2022</last_update_submitted>
  <last_update_submitted_qc>December 5, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 7, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Heart Failure</keyword>
  <keyword>Telemedicine</keyword>
  <keyword>Uganda</keyword>
  <keyword>mHealth</keyword>
  <keyword>Implementation Science</keyword>
  <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>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 15, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/30/NCT04426630/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>April 15, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/30/NCT04426630/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>mHealth</title>
          <description>Heart failure patients in Uganda were enrolled in an mHealth program at the Uganda Heart Institute. The program intended to promote self-care for heart failure and improve patient healthcare quality of life.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="72"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="66"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>mHealth</title>
          <description>Heart failure patients enrolled in the mHealth program&#xD;
mHealth for heart failure patients in Uganda: Patients at Uganda Heart Institute will be enrolled in an mHealth program intended to promote self-care for heart failure and improve their healthcare quality of life.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="72"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="70"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="53.0" lower_limit="40.0" upper_limit="65.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <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="72"/>
                  </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="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Uganda</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Healthcare Quality of Life: EQ-5D</title>
          <description>Healthcare quality of life will be measured using the 5-level EQ-5D version (EQ-5D-5L). It is a validated instrument appropriate for use in lower and middle income countries. Each of the five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) comprises the EQ-5D descriptive system. We regrouped the 5 levels of perceived problems into binary responses as &quot;no problem&quot; (Level 1), or &quot;Having problems&quot; (Level 2-5).</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Mobility</title>
              <category_list>
                <category>
                  <title>No Problem</title>
                  <measurement_list>
                    <measurement group_id="B1" value="47"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Having Problems</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Self-Care</title>
              <category_list>
                <category>
                  <title>No Problem</title>
                  <measurement_list>
                    <measurement group_id="B1" value="42"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Having Problems</title>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Usual Activities</title>
              <category_list>
                <category>
                  <title>No Problem</title>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Having Problems</title>
                  <measurement_list>
                    <measurement group_id="B1" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain or Discomfort</title>
              <category_list>
                <category>
                  <title>No Problem</title>
                  <measurement_list>
                    <measurement group_id="B1" value="42"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Having Problems</title>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anxiety or Depression</title>
              <category_list>
                <category>
                  <title>No Problem</title>
                  <measurement_list>
                    <measurement group_id="B1" value="44"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Having Problems</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Health Quality of Life: EQ VAS</title>
          <description>The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the 100 indicates 'The best health you can imagine' and 0 means 'The worst health you can imagine'.</description>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="70" lower_limit="50" upper_limit="80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Self-Care for Heart Failure Index, Maintenance</title>
        <description>The Self-care of Heart Failure Index (SCHFI) is a measure of self-care defined as a naturalistic decision-making process involving the choice of behaviors that maintain physiological stability (maintenance), the response to symptoms when they occur (management), and confidence in self-care (confidence). The self-care maintenance subscale includes 10 items asking how often patients check their heart failure symptoms and treatment adherence. The score is standardized to a 0- to 100-point range: raw score sum minus lowest possible raw scale score, then divided by the possible range of scores, and finally multiplied by 100. Higher score for each scale indicates better self-maintenance.</description>
        <time_frame>Baseline and Six-month follow-up</time_frame>
        <population>6 participants did not complete six months assessment: 4 participants deceased during the study period and 2 participants lost follow-up.</population>
        <group_list>
          <group group_id="O1">
            <title>mHealth</title>
            <description>Heart failure patients in Uganda were enrolled in an mHealth program at the Uganda Heart Institute. The program intended to promote self-care for heart failure and improve patient healthcare quality of life.</description>
          </group>
        </group_list>
        <measure>
          <title>Self-Care for Heart Failure Index, Maintenance</title>
          <description>The Self-care of Heart Failure Index (SCHFI) is a measure of self-care defined as a naturalistic decision-making process involving the choice of behaviors that maintain physiological stability (maintenance), the response to symptoms when they occur (management), and confidence in self-care (confidence). The self-care maintenance subscale includes 10 items asking how often patients check their heart failure symptoms and treatment adherence. The score is standardized to a 0- to 100-point range: raw score sum minus lowest possible raw scale score, then divided by the possible range of scores, and finally multiplied by 100. Higher score for each scale indicates better self-maintenance.</description>
          <population>6 participants did not complete six months assessment: 4 participants deceased during the study period and 2 participants lost follow-up.</population>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="72"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="72"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35" lower_limit="20" upper_limit="47.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Six-month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="66"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="85" lower_limit="70" upper_limit="85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Heart failure patients in Uganda were enrolled in an mHealth program at the Uganda Heart Institute. The program intended to promote self-care for heart failure and improve patient healthcare quality of life.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
            <method_desc>Wilcoxon signed rank test</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Self-Care for Heart Failure Index, Management</title>
        <description>The Self-care of Heart Failure Index (SCHFI) is a measure of self-care defined as a naturalistic decision-making process involving the choice of behaviors that maintain physiological stability (maintenance), the response to symptoms when they occur (management), and confidence in self-care (confidence). The self-care management subscale includes 6 items if patients report any heart failure symptoms in the past month. Then based on the responses on how quick they recognize it as a symptom of heart failure and remedies they tried, the score is standardized to a 0- to 100-point range: raw score sum minus lowest possible raw scale score, then divided by the possible range of scores, and finally multiplied by 100. Higher score for each scale indicates better self-management.</description>
        <time_frame>Baseline and Six-month follow-up</time_frame>
        <population>The management sub-scale only score if the patient acknowledged having trouble breathing or ankle swelling in the past interval.</population>
        <group_list>
          <group group_id="O1">
            <title>mHealth</title>
            <description>Heart failure patients in Uganda were enrolled in an mHealth program at the Uganda Heart Institute. The program intended to promote self-care for heart failure and improve patient healthcare quality of life.</description>
          </group>
        </group_list>
        <measure>
          <title>Self-Care for Heart Failure Index, Management</title>
          <description>The Self-care of Heart Failure Index (SCHFI) is a measure of self-care defined as a naturalistic decision-making process involving the choice of behaviors that maintain physiological stability (maintenance), the response to symptoms when they occur (management), and confidence in self-care (confidence). The self-care management subscale includes 6 items if patients report any heart failure symptoms in the past month. Then based on the responses on how quick they recognize it as a symptom of heart failure and remedies they tried, the score is standardized to a 0- to 100-point range: raw score sum minus lowest possible raw scale score, then divided by the possible range of scores, and finally multiplied by 100. Higher score for each scale indicates better self-management.</description>
          <population>The management sub-scale only score if the patient acknowledged having trouble breathing or ankle swelling in the past interval.</population>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="72"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20" lower_limit="10" upper_limit="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Six-month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="85" lower_limit="70" upper_limit="85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
            <method_desc>Wilcoxon signed rank test</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Self-Care for Heart Failure Index, Confidence</title>
        <description>The Self-care of Heart Failure Index (SCHFI) is a measure of self-care defined as a naturalistic decision-making process involving the choice of behaviors that maintain physiological stability (maintenance), the response to symptoms when they occur (management), and confidence in self-care (confidence). The self-care confidence subscale includes 6 items asking how confident that they can keep themselves free of symptoms, follow treatment advice, recognize changes in their health and etc.. The score is standardized to a 0- to 100-point range: raw score sum minus lowest possible raw scale score, then divided by the possible range of scores, and finally multiplied by 100. Higher score for each scale indicates better self-confidence</description>
        <time_frame>Baseline and Six-month follow-up</time_frame>
        <population>6 participants did not complete six months assessment: 4 participants deceased during the study period and 2 participants lost follow-up.</population>
        <group_list>
          <group group_id="O1">
            <title>mHealth</title>
            <description>Heart failure patients in Uganda were enrolled in an mHealth program at the Uganda Heart Institute. The program intended to promote self-care for heart failure and improve patient healthcare quality of life.</description>
          </group>
        </group_list>
        <measure>
          <title>Self-Care for Heart Failure Index, Confidence</title>
          <description>The Self-care of Heart Failure Index (SCHFI) is a measure of self-care defined as a naturalistic decision-making process involving the choice of behaviors that maintain physiological stability (maintenance), the response to symptoms when they occur (management), and confidence in self-care (confidence). The self-care confidence subscale includes 6 items asking how confident that they can keep themselves free of symptoms, follow treatment advice, recognize changes in their health and etc.. The score is standardized to a 0- to 100-point range: raw score sum minus lowest possible raw scale score, then divided by the possible range of scores, and finally multiplied by 100. Higher score for each scale indicates better self-confidence</description>
          <population>6 participants did not complete six months assessment: 4 participants deceased during the study period and 2 participants lost follow-up.</population>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="72"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="72"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.2" lower_limit="23.5" upper_limit="52.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Six-month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="66"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.1" lower_limit="88.2" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
            <method_desc>Wilcoxon signed rank test</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>EQ-5D-5L, Mobility</title>
        <description>Measure Description: Healthcare quality of life will be measured using the 5-level EQ-5D version (EQ-5D-5L). It is a validated instrument appropriate for use in lower and middle income countries. Each of the five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) comprises the EQ-5D descriptive system. We regrouped the 5 levels of perceived problems into binary responses as &quot;no problem&quot; (Level 1), or &quot;Having problems&quot; (Level 2-5).</description>
        <time_frame>Baseline and Six-month follow-up visit</time_frame>
        <population>6 participants did not complete six months assessment: 4 participants deceased during the study period and 2 participants lost follow-up.</population>
        <group_list>
          <group group_id="O1">
            <title>mHealth</title>
            <description>Heart failure patients in Uganda were enrolled in an mHealth program at the Uganda Heart Institute. The program intended to promote self-care for heart failure and improve patient healthcare quality of life.</description>
          </group>
        </group_list>
        <measure>
          <title>EQ-5D-5L, Mobility</title>
          <description>Measure Description: Healthcare quality of life will be measured using the 5-level EQ-5D version (EQ-5D-5L). It is a validated instrument appropriate for use in lower and middle income countries. Each of the five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) comprises the EQ-5D descriptive system. We regrouped the 5 levels of perceived problems into binary responses as &quot;no problem&quot; (Level 1), or &quot;Having problems&quot; (Level 2-5).</description>
          <population>6 participants did not complete six months assessment: 4 participants deceased during the study period and 2 participants lost follow-up.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="72"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="72"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>No Problems</title>
                  <measurement_list>
                    <measurement group_id="O1" value="47"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Having Problems</title>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Six-month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="66"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>No Problems</title>
                  <measurement_list>
                    <measurement group_id="O1" value="54"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Having Problems</title>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Heart failure patients in Uganda were enrolled in an mHealth program at the Uganda Heart Institute. The program intended to promote self-care for heart failure and improve patient healthcare quality of life.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.028</p_value>
            <method>Chi-squared</method>
            <method_desc>Wilcoxon sign-rank test used to compared baseline outcomes to 6 month outcomes.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>EQ-5D-5L, Self-Care</title>
        <description>Measure Description: Healthcare quality of life will be measured using the 5-level EQ-5D version (EQ-5D-5L). It is a validated instrument appropriate for use in lower and middle income countries. Each of the five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) comprises the EQ-5D descriptive system. We regrouped the 5 levels of perceived problems into binary responses as &quot;no problem&quot; (Level 1), or &quot;Having problems&quot; (Level 2-5).</description>
        <time_frame>Baseline and Six-month follow-up visit</time_frame>
        <population>6 participants did not complete six months assessment: 4 participants deceased during the study period and 2 participants lost follow-up.</population>
        <group_list>
          <group group_id="O1">
            <title>mHealth</title>
            <description>Heart failure patients in Uganda were enrolled in an mHealth program at the Uganda Heart Institute. The program intended to promote self-care for heart failure and improve patient healthcare quality of life.</description>
          </group>
        </group_list>
        <measure>
          <title>EQ-5D-5L, Self-Care</title>
          <description>Measure Description: Healthcare quality of life will be measured using the 5-level EQ-5D version (EQ-5D-5L). It is a validated instrument appropriate for use in lower and middle income countries. Each of the five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) comprises the EQ-5D descriptive system. We regrouped the 5 levels of perceived problems into binary responses as &quot;no problem&quot; (Level 1), or &quot;Having problems&quot; (Level 2-5).</description>
          <population>6 participants did not complete six months assessment: 4 participants deceased during the study period and 2 participants lost follow-up.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="72"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="72"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>No problems</title>
                  <measurement_list>
                    <measurement group_id="O1" value="42"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Having problems</title>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Six-month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="66"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>No problems</title>
                  <measurement_list>
                    <measurement group_id="O1" value="58"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Having problems</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>EQ-5D-5L, Usual Activities</title>
        <description>Measure Description: Healthcare quality of life will be measured using the 5-level EQ-5D version (EQ-5D-5L). It is a validated instrument appropriate for use in lower and middle income countries. Each of the five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) comprises the EQ-5D descriptive system. We regrouped the 5 levels of perceived problems into binary responses as &quot;no problem&quot; (Level 1), or &quot;Having problems&quot; (Level 2-5).</description>
        <time_frame>Baseline and Six-month follow-up visit</time_frame>
        <population>6 participants did not complete six months assessment: 4 participants deceased during the study period and 2 participants lost follow-up.</population>
        <group_list>
          <group group_id="O1">
            <title>mHealth</title>
            <description>Heart failure patients in Uganda were enrolled in an mHealth program at the Uganda Heart Institute. The program intended to promote self-care for heart failure and improve patient healthcare quality of life.</description>
          </group>
        </group_list>
        <measure>
          <title>EQ-5D-5L, Usual Activities</title>
          <description>Measure Description: Healthcare quality of life will be measured using the 5-level EQ-5D version (EQ-5D-5L). It is a validated instrument appropriate for use in lower and middle income countries. Each of the five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) comprises the EQ-5D descriptive system. We regrouped the 5 levels of perceived problems into binary responses as &quot;no problem&quot; (Level 1), or &quot;Having problems&quot; (Level 2-5).</description>
          <population>6 participants did not complete six months assessment: 4 participants deceased during the study period and 2 participants lost follow-up.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="72"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="72"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>No problems</title>
                  <measurement_list>
                    <measurement group_id="O1" value="33"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Having problems</title>
                  <measurement_list>
                    <measurement group_id="O1" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Six-month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="66"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>No problems</title>
                  <measurement_list>
                    <measurement group_id="O1" value="54"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Having problems</title>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>EQ-5D-5L, Pain or Discomfort</title>
        <description>Measure Description: Healthcare quality of life will be measured using the 5-level EQ-5D version (EQ-5D-5L). It is a validated instrument appropriate for use in lower and middle income countries. Each of the five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) comprises the EQ-5D descriptive system. We regrouped the 5 levels of perceived problems into binary responses as &quot;no problem&quot; (Level 1), or &quot;Having problems&quot; (Level 2-5).</description>
        <time_frame>Baseline and Six-month follow-up visit</time_frame>
        <population>6 participants did not complete six months assessment: 4 participants deceased during the study period and 2 participants lost follow-up.</population>
        <group_list>
          <group group_id="O1">
            <title>mHealth</title>
            <description>Heart failure patients in Uganda were enrolled in an mHealth program at the Uganda Heart Institute. The program intended to promote self-care for heart failure and improve patient healthcare quality of life.</description>
          </group>
        </group_list>
        <measure>
          <title>EQ-5D-5L, Pain or Discomfort</title>
          <description>Measure Description: Healthcare quality of life will be measured using the 5-level EQ-5D version (EQ-5D-5L). It is a validated instrument appropriate for use in lower and middle income countries. Each of the five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) comprises the EQ-5D descriptive system. We regrouped the 5 levels of perceived problems into binary responses as &quot;no problem&quot; (Level 1), or &quot;Having problems&quot; (Level 2-5).</description>
          <population>6 participants did not complete six months assessment: 4 participants deceased during the study period and 2 participants lost follow-up.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="72"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="72"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>No problems</title>
                  <measurement_list>
                    <measurement group_id="O1" value="42"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Having problems</title>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Six-month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="66"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>No problems</title>
                  <measurement_list>
                    <measurement group_id="O1" value="45"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Having problems</title>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.23</p_value>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>EQ-5D-5L, Anxiety or Depression</title>
        <description>Measure Description: Healthcare quality of life will be measured using the 5-level EQ-5D version (EQ-5D-5L). It is a validated instrument appropriate for use in lower and middle income countries. Each of the five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) comprises the EQ-5D descriptive system. We regrouped the 5 levels of perceived problems into binary responses as &quot;no problem&quot; (Level 1), or &quot;Having problems&quot; (Level 2-5).</description>
        <time_frame>Baseline and Six-month follow-up visit</time_frame>
        <population>6 participants did not complete six months assessment: 4 participants deceased during the study period and 2 participants lost follow-up.</population>
        <group_list>
          <group group_id="O1">
            <title>mHealth</title>
            <description>Heart failure patients in Uganda were enrolled in an mHealth program at the Uganda Heart Institute. The program intended to promote self-care for heart failure and improve patient healthcare quality of life.</description>
          </group>
        </group_list>
        <measure>
          <title>EQ-5D-5L, Anxiety or Depression</title>
          <description>Measure Description: Healthcare quality of life will be measured using the 5-level EQ-5D version (EQ-5D-5L). It is a validated instrument appropriate for use in lower and middle income countries. Each of the five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) comprises the EQ-5D descriptive system. We regrouped the 5 levels of perceived problems into binary responses as &quot;no problem&quot; (Level 1), or &quot;Having problems&quot; (Level 2-5).</description>
          <population>6 participants did not complete six months assessment: 4 participants deceased during the study period and 2 participants lost follow-up.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="72"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="72"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>No problems</title>
                  <measurement_list>
                    <measurement group_id="O1" value="44"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Having problems</title>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Six-month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="66"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>No problems</title>
                  <measurement_list>
                    <measurement group_id="O1" value="57"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Having problems</title>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>EQ-5D-5L, VAS</title>
        <description>The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the 100 indicates 'The best health you can imagine' and 0 means 'The worst health you can imagine'.</description>
        <time_frame>Baseline and Six-month follow-up visit</time_frame>
        <population>6 participants did not complete six months assessment: 4 participants deceased during the study period and 2 participants lost follow-up.</population>
        <group_list>
          <group group_id="O1">
            <title>mHealth</title>
            <description>Heart failure patients in Uganda were enrolled in an mHealth program at the Uganda Heart Institute. The program intended to promote self-care for heart failure and improve patient healthcare quality of life.</description>
          </group>
        </group_list>
        <measure>
          <title>EQ-5D-5L, VAS</title>
          <description>The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the 100 indicates 'The best health you can imagine' and 0 means 'The worst health you can imagine'.</description>
          <population>6 participants did not complete six months assessment: 4 participants deceased during the study period and 2 participants lost follow-up.</population>
          <units>score on the visual analogue scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="72"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="72"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70" lower_limit="50" upper_limit="80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Six-month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="66"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80" lower_limit="75" upper_limit="90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
            <method_desc>Wilcoxon signed rank test</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Six-Minute Walk Test, Total Distance</title>
        <description>Patients' functional capacity will be assessed using the Six-Minute Walk Test, a widely-used, reproducible exercise test that serves as a strong predictor of morbidity and mortality in heart failure patients. Outcome is measured as a distance in meters. Possible range is 0-700m. Healthy range is considered 400-700m but may not be normative for all populations, including people with chronic diseases. In this study difference in distance (meters) will be examined across visits, with a lower score reflecting worse function.</description>
        <time_frame>Baseline and Six-month follow-up visit</time_frame>
        <population>6 participants did not complete six months assessment: 4 participants deceased during the study period and 2 participants lost follow-up.</population>
        <group_list>
          <group group_id="O1">
            <title>mHealth</title>
            <description>Heart failure patients in Uganda were enrolled in an mHealth program at the Uganda Heart Institute. The program intended to promote self-care for heart failure and improve patient healthcare quality of life.</description>
          </group>
        </group_list>
        <measure>
          <title>Six-Minute Walk Test, Total Distance</title>
          <description>Patients' functional capacity will be assessed using the Six-Minute Walk Test, a widely-used, reproducible exercise test that serves as a strong predictor of morbidity and mortality in heart failure patients. Outcome is measured as a distance in meters. Possible range is 0-700m. Healthy range is considered 400-700m but may not be normative for all populations, including people with chronic diseases. In this study difference in distance (meters) will be examined across visits, with a lower score reflecting worse function.</description>
          <population>6 participants did not complete six months assessment: 4 participants deceased during the study period and 2 participants lost follow-up.</population>
          <units>Meters</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="72"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="72"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="320.3" lower_limit="220.0" upper_limit="360.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Six-month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="66"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="340.0" lower_limit="280.0" upper_limit="420.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
            <method_desc>Wilcoxon signed rank test</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Left Ventricular Ejection Fraction</title>
        <description>Left ventricular ejection fraction (LVEF) is a widely-recognized clinical prognostic marker for heart failure patients. It is measured as a percentage. Possible range is 0-100. Low is &lt;50%. High is &gt;=50%. LVEF is measured by echocardiogram using Simpson biplane formula</description>
        <time_frame>Baseline and Six-month follow-up visit</time_frame>
        <population>6 participants did not complete six months assessment: 4 participants deceased during the study period and 2 participants lost follow-up.</population>
        <group_list>
          <group group_id="O1">
            <title>mHealth</title>
            <description>Heart failure patients in Uganda were enrolled in an mHealth program at the Uganda Heart Institute. The program intended to promote self-care for heart failure and improve patient healthcare quality of life.</description>
          </group>
        </group_list>
        <measure>
          <title>Left Ventricular Ejection Fraction</title>
          <description>Left ventricular ejection fraction (LVEF) is a widely-recognized clinical prognostic marker for heart failure patients. It is measured as a percentage. Possible range is 0-100. Low is &lt;50%. High is &gt;=50%. LVEF is measured by echocardiogram using Simpson biplane formula</description>
          <population>6 participants did not complete six months assessment: 4 participants deceased during the study period and 2 participants lost follow-up.</population>
          <units>Percentage of Left Ventricular Ejection</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="72"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="72"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30" lower_limit="23.5" upper_limit="34.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Six-month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="66"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.0" lower_limit="21.0" upper_limit="40.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.07</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
            <method_desc>Wilcoxon signed rank test</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Frequency of Acute Care Visits</title>
        <description>Patients will be asked to report how often they required acute care for their heart failure outside of their usual care. This outcome is the frequency of acute care visits as categorical variable: 0, 1 and ≥2. Possible range is 0-31.</description>
        <time_frame>Baseline and Six-month follow-up visit</time_frame>
        <population>6 participants did not complete six months assessment: 4 participants deceased during the study period and 2 participants lost follow-up.</population>
        <group_list>
          <group group_id="O1">
            <title>mHealth</title>
            <description>Heart failure patients in Uganda were enrolled in an mHealth program at the Uganda Heart Institute. The program intended to promote self-care for heart failure and improve patient healthcare quality of life.</description>
          </group>
        </group_list>
        <measure>
          <title>Frequency of Acute Care Visits</title>
          <description>Patients will be asked to report how often they required acute care for their heart failure outside of their usual care. This outcome is the frequency of acute care visits as categorical variable: 0, 1 and ≥2. Possible range is 0-31.</description>
          <population>6 participants did not complete six months assessment: 4 participants deceased during the study period and 2 participants lost follow-up.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="72"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="72"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="56"/>
                  </measurement_list>
                </category>
                <category>
                  <title>1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>≥2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Six-month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="66"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="60"/>
                  </measurement_list>
                </category>
                <category>
                  <title>1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>≥2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>6 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>mHealth</title>
          <description>Heart failure patients in Uganda were enrolled in an mHealth program at the Uganda Heart Institute. The program intended to promote self-care for heart failure and improve patient healthcare quality of life.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="72"/>
              </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="72"/>
              </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>Dr. Jeremy Schwartz</name_or_title>
      <organization>Yale University School of Medicine</organization>
      <phone>2036801598</phone>
      <email>jeremy.schwartz@yale.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/NCT04426630
org study id: 2000025338
secondary id: 1R21TW010998-01A1
nct id: NCT04426630
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Heart failure affects more than 38 million people globally. It is responsible for high rates
      of hospitalization and premature mortality, especially in sub-Saharan Africa. Heart failure
      causes multiple debilitating and distressing symptoms. These symptoms can often be managed by
      patients themselves but only when they are able to identify symptoms and select appropriate
      actions. Self-care, a World Health Organization-endorsed intervention for chronic conditions
      like heart failure, is greatly underutilized in lower and middle income countries, including
      Uganda. Self-care refers to the ability of patients, caregivers and communities to maintain
      health, prevent disease, and manage illness, with or without a healthcare provider. Mobile
      health (mHealth) offers a promising platform to address this need gap in lower and middle
      income countries. mHealth takes advantage of the widespread usage of mobile phones to offer
      patients individualized self-care tools such as education, healthy lifestyle prompts, and
      support with making decisions. Since 2016, this multidisciplinary, international research
      team has been designing Medly Uganda, an mHealth application to improve self-care among
      Ugandan patients with heart failure. This application began as a smartphone but was adapted
      for the low-cost feature phones used widely throughout the country. It was also integrated
      into an mHealth system endorsed by the Ugandan Ministry of Health. When patients log in they
      are prompted to report on specific heart failure symptoms. The application then generates
      self-care instructions based on those symptoms. If a patient reports serious symptoms the
      application triggers an alert to the research nurse, who then consults with the patient,
      caregiver, and if needed, cardiologist, to establish a plan of care. This study proposes that
      an mHealth intervention tailored specifically to the local context will improve healthcare
      quality of life for patients with heart failure. The research team hypothesizes that heart
      failure patients who use the program will report improved scores on the Self-Care in Heart
      Failure Index. These scores will be assessed at baseline, three-month, and six-month visits.
      The researchers will also measure changes in patients' clinical conditions, including the
      6-minute walk test, left ventricular ejection fraction, and frequency of acute care visits.
      Finally, the researchers will conduct qualitative interviews with patients and providers to
      understand their experiences.
Participants will be asked to initiate self-care sessions using the Medly Uganda application.
      They will dial the sub-code and enter a unique PIN to access the system. They are asked to do
      this every Monday, Wednesday, and Friday morning for six months, as well as anytime that they
      experience concerning symptoms. If a participant has not initiated a session by 11:00am on
      the designated days, the application will generate an SMS reminder. Each interactive session
      will present a series of symptom-based questions to the participant. These questions will be
      followed by a tailored SMS message. While session content will not remain on the
      participant's phone, the SMS messages will. This allows participants to retain and review
      messages, thereby reinforcing educational content. There are four status categories: Stable,
      Fluid Overload, Urgent, and Critical. If Stable, participants will be sent one of six
      encouraging and educational messages. If Fluid Overload, Urgent or Critical, patient
      participants will be sent a message that identifies the symptom and recommends an action and
      the on-duty nurse will be sent an accompanying alert. Urgent and Critical alerts will also be
      sent to the on-duty doctor. The nurse is expected to call the patient for Urgent and Critical
      alerts within 60 and 15 minutes, respectively. Nurse phone call interactions will be guided
      by a standard operating manual. One nurse and one doctor will be designated rotating
      'on-duty' responsibility to monitor clinician alerts and the dashboard seven days a week. The
      doctor will be available to provide clinical supervision to the nurse as needed and they will
      have a daily in-person or by-phone.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: This is a single-center prospective cohort study. The researchers will use consecutive sampling to identify potential patient participants.
primary purpose: Treatment
masking: None (Open Label)
measure: Self-Care for Heart Failure Index, Maintenance
time frame: Baseline and Six-month follow-up
description: The Self-care of Heart Failure Index (SCHFI) is a measure of self-care defined as a naturalistic decision-making process involving the choice of behaviors that maintain physiological stability (maintenance), the response to symptoms when they occur (management), and confidence in self-care (confidence). The self-care maintenance subscale includes 10 items asking how often patients check their heart failure symptoms and treatment adherence. The score is standardized to a 0- to 100-point range: raw score sum minus lowest possible raw scale score, then divided by the possible range of scores, and finally multiplied by 100. Higher score for each scale indicates better self-maintenance.
measure: Self-Care for Heart Failure Index, Management
time frame: Baseline and Six-month follow-up
description: The Self-care of Heart Failure Index (SCHFI) is a measure of self-care defined as a naturalistic decision-making process involving the choice of behaviors that maintain physiological stability (maintenance), the response to symptoms when they occur (management), and confidence in self-care (confidence). The self-care management subscale includes 6 items if patients report any heart failure symptoms in the past month. Then based on the responses on how quick they recognize it as a symptom of heart failure and remedies they tried, the score is standardized to a 0- to 100-point range: raw score sum minus lowest possible raw scale score, then divided by the possible range of scores, and finally multiplied by 100. Higher score for each scale indicates better self-management.
measure: Self-Care for Heart Failure Index, Confidence
time frame: Baseline and Six-month follow-up
description: The Self-care of Heart Failure Index (SCHFI) is a measure of self-care defined as a naturalistic decision-making process involving the choice of behaviors that maintain physiological stability (maintenance), the response to symptoms when they occur (management), and confidence in self-care (confidence). The self-care confidence subscale includes 6 items asking how confident that they can keep themselves free of symptoms, follow treatment advice, recognize changes in their health and etc.. The score is standardized to a 0- to 100-point range: raw score sum minus lowest possible raw scale score, then divided by the possible range of scores, and finally multiplied by 100. Higher score for each scale indicates better self-confidence
measure: EQ-5D-5L, Mobility
time frame: Baseline and Six-month follow-up visit
description: Measure Description: Healthcare quality of life will be measured using the 5-level EQ-5D version (EQ-5D-5L). It is a validated instrument appropriate for use in lower and middle income countries. Each of the five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) comprises the EQ-5D descriptive system. We regrouped the 5 levels of perceived problems into binary responses as "no problem" (Level 1), or "Having problems" (Level 2-5).
measure: EQ-5D-5L, Self-Care
time frame: Baseline and Six-month follow-up visit
description: Measure Description: Healthcare quality of life will be measured using the 5-level EQ-5D version (EQ-5D-5L). It is a validated instrument appropriate for use in lower and middle income countries. Each of the five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) comprises the EQ-5D descriptive system. We regrouped the 5 levels of perceived problems into binary responses as "no problem" (Level 1), or "Having problems" (Level 2-5).
measure: EQ-5D-5L, Usual Activities
time frame: Baseline and Six-month follow-up visit
description: Measure Description: Healthcare quality of life will be measured using the 5-level EQ-5D version (EQ-5D-5L). It is a validated instrument appropriate for use in lower and middle income countries. Each of the five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) comprises the EQ-5D descriptive system. We regrouped the 5 levels of perceived problems into binary responses as "no problem" (Level 1), or "Having problems" (Level 2-5).
measure: EQ-5D-5L, Pain or Discomfort
time frame: Baseline and Six-month follow-up visit
description: Measure Description: Healthcare quality of life will be measured using the 5-level EQ-5D version (EQ-5D-5L). It is a validated instrument appropriate for use in lower and middle income countries. Each of the five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) comprises the EQ-5D descriptive system. We regrouped the 5 levels of perceived problems into binary responses as "no problem" (Level 1), or "Having problems" (Level 2-5).
measure: EQ-5D-5L, Anxiety or Depression
time frame: Baseline and Six-month follow-up visit
description: Measure Description: Healthcare quality of life will be measured using the 5-level EQ-5D version (EQ-5D-5L). It is a validated instrument appropriate for use in lower and middle income countries. Each of the five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) comprises the EQ-5D descriptive system. We regrouped the 5 levels of perceived problems into binary responses as "no problem" (Level 1), or "Having problems" (Level 2-5).
measure: EQ-5D-5L, VAS
time frame: Baseline and Six-month follow-up visit
description: The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the 100 indicates 'The best health you can imagine' and 0 means 'The worst health you can imagine'.
measure: Six-Minute Walk Test, Total Distance
time frame: Baseline and Six-month follow-up visit
description: Patients' functional capacity will be assessed using the Six-Minute Walk Test, a widely-used, reproducible exercise test that serves as a strong predictor of morbidity and mortality in heart failure patients. Outcome is measured as a distance in meters. Possible range is 0-700m. Healthy range is considered 400-700m but may not be normative for all populations, including people with chronic diseases. In this study difference in distance (meters) will be examined across visits, with a lower score reflecting worse function.
measure: Left Ventricular Ejection Fraction
time frame: Baseline and Six-month follow-up visit
description: Left ventricular ejection fraction (LVEF) is a widely-recognized clinical prognostic marker for heart failure patients. It is measured as a percentage. Possible range is 0-100. Low is <50%. High is >=50%. LVEF is measured by echocardiogram using Simpson biplane formula
measure: Frequency of Acute Care Visits
time frame: Baseline and Six-month follow-up visit
description: Patients will be asked to report how often they required acute care for their heart failure outside of their usual care. This outcome is the frequency of acute care visits as categorical variable: 0, 1 and ≥2. Possible range is 0-31.
arm group label: mHealth
arm group type: Other
description: Heart failure patients enrolled in the mHealth program
intervention type: Other
intervention name: mHealth for heart failure patients in Uganda
description: Patients at Uganda Heart Institute will be enrolled in an mHealth program intended to promote self-care for heart failure and improve their healthcare quality of life.
arm group label: mHealth
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Jeremy Schwartz, MD
role: Principal Investigator
affiliation: Yale University
last name: Isaac Ssinabulya, MMed
role: Principal Investigator
affiliation: Uganda Heart Institute
facility: 
country: Uganda
responsible party type: Sponsor
mesh term: Heart Failure
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 