<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/NCT03794713</url>
  </required_header>
  <id_info>
    <org_study_id>SUPPORT V1.0</org_study_id>
    <nct_id>NCT03794713</nct_id>
  </id_info>
  <brief_title>A Randomized, Two-arm, Open Label Study to evalUate the Effect of a Smart Phone-based Patient Support Tool On Patient AdheRence of Treatment in Stable Angina Patients Prescribed Beta-blockers in China (SUPPORT)</brief_title>
  <official_title>A Randomized, Two-arm, Open Label Study to evalUate the Effect of a Smart Phone-based Patient Support Tool On Patient AdheRence of Treatment in Stable Angina Patients Prescribed Beta-blockers in China (SUPPORT)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shenyang Northern Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shenyang Northern Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The present study aims to enhance the adherence of beta-blockers by Patient Support Tool&#xD;
      through a smart phone application and a wristband, subsequently reduce the risk of angina&#xD;
      attacks in patients with stable angina pectoris.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To control heart rate in terms of guidelines in patients with stable angina pectoris reduces&#xD;
      risk of cardiovascular events, rehospitalization, and death effectively. Using beta blockers&#xD;
      is an efficient therapy to management the HR in SAP patients. However, the recent&#xD;
      epidemiological studies have provided evidences that the rate of beta blocker prescribed and&#xD;
      used was inadequate, as the first-line therapy to CAD patients with the usage rate less than&#xD;
      30%. Several studies showed that with a reminder supported by smart phones and wearable&#xD;
      devices, the adherence of management of patients with chronic disease could be improved&#xD;
      significantly.Thus,the present study aims to enhance the adherence of beta-blockers by&#xD;
      Patient Support Tool through a smart phone application and a wristband, subsequently reduce&#xD;
      the risk of angina attacks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">April 1, 2019</start_date>
  <completion_date type="Anticipated">September 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adherence to beta-blockers</measure>
    <time_frame>24 weeks</time_frame>
    <description>To evaluate the effect of Patient Support Tool through a smart phone application and a wristband on adherence to beta-blockers in patients with stable coronary artery disease.Duration of treatment-defined as the days the Patient has taken beta-blockers followed the advice of doctors during the 24-week follow up.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Impact of resting heart rate</measure>
    <time_frame>24 weeks</time_frame>
    <description>To evaluate the impact of the Patient Support Tool on rHR (resting heart rate).The difference of the average rHR change from baseline between 2 groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of angina attacks</measure>
    <time_frame>24 weeks</time_frame>
    <description>To evaluate the impact of the Patient Support Tool on Angina attacks. The difference of the score change of Seattle angina Questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Major adverse cardiovascular events</measure>
    <time_frame>24 weeks</time_frame>
    <description>To evaluate the impact of the Patient Support Tool on major adverse cardiovascular events (MACE), a composite of cardiac death, myocardial infarction, stroke, and revascularization.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">432</enrollment>
  <condition>Adrenergic Beta-Antagonists</condition>
  <condition>Stable Angina Pectoris</condition>
  <condition>Medication Adherence</condition>
  <condition>Mobile Applications</condition>
  <arm_group>
    <arm_group_label>Patient support tool group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects were managed the HR by using the Patient Support Tool through a smart phone application and a wristband and be guided by physicians</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Subjects were received a usual patient care at baseline, which left to the discretion of physicians, without any specific intervention at follow-up period</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Patient support tool</intervention_name>
    <description>The patient support tool, a software app installed on the smart phones plus a wrist connected to the smart phones by Bluetooth. The wrist could monitor the pulse, which was recorded to the app in the smart phone. Meanwhile, the app could inform to patients about the importance of medication, remind on the medicine intake, share the patients' data with themselves, and warn the patients if the wrist don't wear.</description>
    <arm_group_label>Patient support tool group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Aged 18-70 years;&#xD;
&#xD;
          2. Stable angina pectoris;&#xD;
&#xD;
          3. Indicated for beta blockers;&#xD;
&#xD;
          4. HR ≥ 60bpm;&#xD;
&#xD;
          5. Patient must have a smart phone that is compatible with the Patient support tool at&#xD;
             their disposal and are comfortable with using of interactive smart phone applications.&#xD;
             The required specification for the phone will be determined after completed testing;&#xD;
&#xD;
          6. Ability to read, understand and write Chinese;&#xD;
&#xD;
          7. Beta-blockers naïve or with no Beta-blocker use during the last 1 month.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Previous myocardial infarction during the recent 1 year;&#xD;
&#xD;
          2. Cardiac shock or unstable heart failure (NYHA III);&#xD;
&#xD;
          3. SBP&lt;100 mmHg;&#xD;
&#xD;
          4. Sick sinus syndrome;&#xD;
&#xD;
          5. II-III degree atrioventricular block;&#xD;
&#xD;
          6. Existing contraindication for Beta-blockers or allergic to beta-blockers;&#xD;
&#xD;
          7. Participation in another clinical study with a beta blocker during the last 3 months;&#xD;
&#xD;
          8. Inability to sign the informed consent form;&#xD;
&#xD;
          9. Females during pregnancy and lactation and women of child bearing potential planning&#xD;
             to be pregnant within 24 weeks.;&#xD;
&#xD;
         10. Patients who withdraw from this study for any reason cannot re-enter the study;&#xD;
&#xD;
         11. Life expectancy &lt; 1 year;&#xD;
&#xD;
         12. Severe asthma or COPD;&#xD;
&#xD;
         13. Severe peripheral vascular disease;&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Jing Li, MD</last_name>
    <phone>86-024-28897309</phone>
    <email>lijing790126@sina.com</email>
  </overall_contact>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 3, 2019</study_first_submitted>
  <study_first_submitted_qc>January 3, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 7, 2019</study_first_posted>
  <last_update_submitted>January 3, 2019</last_update_submitted>
  <last_update_submitted_qc>January 3, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 7, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shenyang Northern Hospital</investigator_affiliation>
    <investigator_full_name>Han Yaling</investigator_full_name>
    <investigator_title>Dr</investigator_title>
  </responsible_party>
  <keyword>beta-blocker</keyword>
  <keyword>Stable Angina Pectoris</keyword>
  <keyword>Patient support tool</keyword>
  <keyword>Adherence</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Angina Pectoris</mesh_term>
    <mesh_term>Angina, Stable</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03794713
org study id: SUPPORT V1.0
nct id: NCT03794713
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The present study aims to enhance the adherence of beta-blockers by Patient Support Tool
      through a smart phone application and a wristband, subsequently reduce the risk of angina
      attacks in patients with stable angina pectoris.
To control heart rate in terms of guidelines in patients with stable angina pectoris reduces
      risk of cardiovascular events, rehospitalization, and death effectively. Using beta blockers
      is an efficient therapy to management the HR in SAP patients. However, the recent
      epidemiological studies have provided evidences that the rate of beta blocker prescribed and
      used was inadequate, as the first-line therapy to CAD patients with the usage rate less than
      30%. Several studies showed that with a reminder supported by smart phones and wearable
      devices, the adherence of management of patients with chronic disease could be improved
      significantly.Thus,the present study aims to enhance the adherence of beta-blockers by
      Patient Support Tool through a smart phone application and a wristband, subsequently reduce
      the risk of angina attacks.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Adherence to beta-blockers
time frame: 24 weeks
description: To evaluate the effect of Patient Support Tool through a smart phone application and a wristband on adherence to beta-blockers in patients with stable coronary artery disease.Duration of treatment-defined as the days the Patient has taken beta-blockers followed the advice of doctors during the 24-week follow up.
measure: Impact of resting heart rate
time frame: 24 weeks
description: To evaluate the impact of the Patient Support Tool on rHR (resting heart rate).The difference of the average rHR change from baseline between 2 groups.
measure: Impact of angina attacks
time frame: 24 weeks
description: To evaluate the impact of the Patient Support Tool on Angina attacks. The difference of the score change of Seattle angina Questionnaire.
measure: Major adverse cardiovascular events
time frame: 24 weeks
description: To evaluate the impact of the Patient Support Tool on major adverse cardiovascular events (MACE), a composite of cardiac death, myocardial infarction, stroke, and revascularization.
arm group label: Patient support tool group
arm group type: Experimental
description: Subjects were managed the HR by using the Patient Support Tool through a smart phone application and a wristband and be guided by physicians
arm group label: Control group
arm group type: No Intervention
description: Subjects were received a usual patient care at baseline, which left to the discretion of physicians, without any specific intervention at follow-up period
intervention type: Device
intervention name: Patient support tool
description: The patient support tool, a software app installed on the smart phones plus a wrist connected to the smart phones by Bluetooth. The wrist could monitor the pulse, which was recorded to the app in the smart phone. Meanwhile, the app could inform to patients about the importance of medication, remind on the medicine intake, share the patients' data with themselves, and warn the patients if the wrist don't wear.
arm group label: Patient support tool group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Jing Li, MD
phone: 86-024-28897309
email: lijing790126@sina.com
responsible party type: Principal Investigator
investigator affiliation: Shenyang Northern Hospital
investigator full name: Han Yaling
investigator title: Dr
mesh term: Angina Pectoris
mesh term: Angina, Stable
sharing ipd: No