NCT03794713

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
432

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2019

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 3, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 7, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

January 7, 2019

Status Verified

January 1, 2019

Enrollment Period

1.4 years

First QC Date

January 3, 2019

Last Update Submit

January 3, 2019

Conditions

Adrenergic Beta-AntagonistsStable Angina PectorisMedication AdherenceMobile Applications

Keywords

beta-blockerStable Angina PectorisPatient support toolAdherence

Outcome Measures

Primary Outcomes (1)

  • 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.

    24 weeks

Secondary Outcomes (3)

  • Impact of resting heart rate

    24 weeks

  • Impact of angina attacks

    24 weeks

  • Major adverse cardiovascular events

    24 weeks

Study Arms (2)

Patient support tool group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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

Interventions

Patient support toolDEVICE

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.

Patient support tool group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Angina, StableMedication Adherence

Condition Hierarchy (Ancestors)

Angina PectorisMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Central Study Contacts

Jing Li, MD

CONTACT

86-024-28897309lijing790126@sina.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

January 3, 2019

First Posted

January 7, 2019

Study Start

April 1, 2019

Primary Completion

September 1, 2020

Study Completion

September 1, 2020

Last Updated

January 7, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share