search
Back to results

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)

Primary Purpose

Adrenergic Beta-Antagonists, Stable Angina Pectoris, Medication Adherence

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Patient support tool
Sponsored by
Shenyang Northern Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adrenergic Beta-Antagonists focused on measuring beta-blocker, Stable Angina Pectoris, Patient support tool, Adherence

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Aged 18-70 years;
  2. Stable angina pectoris;
  3. Indicated for beta blockers;
  4. HR ≥ 60bpm;
  5. Patient must have a smart phone that is compatible with the Patient support tool at their disposal and are comfortable with using of interactive smart phone applications. The required specification for the phone will be determined after completed testing;
  6. Ability to read, understand and write Chinese;
  7. Beta-blockers naïve or with no Beta-blocker use during the last 1 month.

Exclusion Criteria:

  1. Previous myocardial infarction during the recent 1 year;
  2. Cardiac shock or unstable heart failure (NYHA III);
  3. SBP<100 mmHg;
  4. Sick sinus syndrome;
  5. II-III degree atrioventricular block;
  6. Existing contraindication for Beta-blockers or allergic to beta-blockers;
  7. Participation in another clinical study with a beta blocker during the last 3 months;
  8. Inability to sign the informed consent form;
  9. Females during pregnancy and lactation and women of child bearing potential planning to be pregnant within 24 weeks.;
  10. Patients who withdraw from this study for any reason cannot re-enter the study;
  11. Life expectancy < 1 year;
  12. Severe asthma or COPD;
  13. Severe peripheral vascular disease;

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Patient support tool group

    Control group

    Arm 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

    Subjects were received a usual patient care at baseline, which left to the discretion of physicians, without any specific intervention at follow-up period

    Outcomes

    Primary Outcome Measures

    Adherence to beta-blockers
    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.

    Secondary Outcome Measures

    Impact of resting heart rate
    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.
    Impact of angina attacks
    To evaluate the impact of the Patient Support Tool on Angina attacks. The difference of the score change of Seattle angina Questionnaire.
    Major adverse cardiovascular events
    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.

    Full Information

    First Posted
    January 3, 2019
    Last Updated
    January 3, 2019
    Sponsor
    Shenyang Northern Hospital
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03794713
    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)
    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)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 1, 2019 (Anticipated)
    Primary Completion Date
    September 1, 2020 (Anticipated)
    Study Completion Date
    September 1, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Shenyang Northern Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Adrenergic Beta-Antagonists, Stable Angina Pectoris, Medication Adherence, Mobile Applications
    Keywords
    beta-blocker, Stable Angina Pectoris, Patient support tool, Adherence

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    432 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Patient support tool group
    Arm Type
    Experimental
    Arm 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 Title
    Control group
    Arm Type
    No Intervention
    Arm 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(s)
    Patient support tool
    Intervention 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.
    Primary Outcome Measure Information:
    Title
    Adherence to beta-blockers
    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.
    Time Frame
    24 weeks
    Secondary Outcome Measure Information:
    Title
    Impact of resting heart rate
    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.
    Time Frame
    24 weeks
    Title
    Impact of angina attacks
    Description
    To evaluate the impact of the Patient Support Tool on Angina attacks. The difference of the score change of Seattle angina Questionnaire.
    Time Frame
    24 weeks
    Title
    Major adverse cardiovascular events
    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.
    Time Frame
    24 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Aged 18-70 years; Stable angina pectoris; Indicated for beta blockers; HR ≥ 60bpm; Patient must have a smart phone that is compatible with the Patient support tool at their disposal and are comfortable with using of interactive smart phone applications. The required specification for the phone will be determined after completed testing; Ability to read, understand and write Chinese; Beta-blockers naïve or with no Beta-blocker use during the last 1 month. Exclusion Criteria: Previous myocardial infarction during the recent 1 year; Cardiac shock or unstable heart failure (NYHA III); SBP<100 mmHg; Sick sinus syndrome; II-III degree atrioventricular block; Existing contraindication for Beta-blockers or allergic to beta-blockers; Participation in another clinical study with a beta blocker during the last 3 months; Inability to sign the informed consent form; Females during pregnancy and lactation and women of child bearing potential planning to be pregnant within 24 weeks.; Patients who withdraw from this study for any reason cannot re-enter the study; Life expectancy < 1 year; Severe asthma or COPD; Severe peripheral vascular disease;
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jing Li, MD
    Phone
    86-024-28897309
    Email
    lijing790126@sina.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    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)

    We'll reach out to this number within 24 hrs