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)
January 3, 2019 updated by: Han Yaling, Shenyang Northern Hospital
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
432
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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;
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / 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
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
24 weeks
|
|
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.
|
24 weeks
|
|
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.
|
24 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
April 1, 2019
Primary Completion (ANTICIPATED)
September 1, 2020
Study Completion (ANTICIPATED)
September 1, 2020
Study Registration Dates
First Submitted
January 3, 2019
First Submitted That Met QC Criteria
January 3, 2019
First Posted (ACTUAL)
January 7, 2019
Study Record Updates
Last Update Posted (ACTUAL)
January 7, 2019
Last Update Submitted That Met QC Criteria
January 3, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SUPPORT V1.0
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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