Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03794713
Recruitment Status : Not yet recruiting
First Posted : January 7, 2019
Last Update Posted : January 7, 2019
Sponsor:
Information provided by (Responsible Party):
Han Yaling, Shenyang Northern Hospital

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.

Condition or disease Intervention/treatment Phase
Adrenergic Beta-Antagonists Stable Angina Pectoris Medication Adherence Mobile Applications Device: Patient support tool Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 432 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Estimated Study Start Date : April 1, 2019
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angina

Arm Intervention/treatment
Experimental: Patient support tool group
Subjects were managed the HR by using the Patient Support Tool through a smart phone application and a wristband and be guided by physicians
Device: Patient support tool
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.

No Intervention: Control group
Subjects were received a usual patient care at baseline, which left to the discretion of physicians, without any specific intervention at follow-up period



Primary Outcome Measures :
  1. Adherence to beta-blockers [ Time Frame: 24 weeks ]
    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 :
  1. Impact of resting heart rate [ Time Frame: 24 weeks ]
    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.

  2. Impact of angina attacks [ Time Frame: 24 weeks ]
    To evaluate the impact of the Patient Support Tool on Angina attacks. The difference of the score change of Seattle angina Questionnaire.

  3. Major adverse cardiovascular events [ Time Frame: 24 weeks ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03794713


Contacts
Layout table for location contacts
Contact: Jing Li, MD 86-024-28897309 lijing790126@sina.com

Sponsors and Collaborators
Shenyang Northern Hospital

Layout table for additonal information
Responsible Party: Han Yaling, Dr, Shenyang Northern Hospital
ClinicalTrials.gov Identifier: NCT03794713     History of Changes
Other Study ID Numbers: SUPPORT V1.0
First Posted: January 7, 2019    Key Record Dates
Last Update Posted: January 7, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Han Yaling, Shenyang Northern Hospital:
beta-blocker
Stable Angina Pectoris
Patient support tool
Adherence
Additional relevant MeSH terms:
Layout table for MeSH terms
Chest Pain
Pain
Angina Pectoris
Angina, Stable
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Neurologic Manifestations
Signs and Symptoms
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs