Adrenergic Beta-AntagonistsNCT03794713
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)
A study testing Patient support tool in people with Adrenergic Beta-Antagonists and Stable Angina Pectoris, run by Shenyang Northern Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Adrenergic Beta-Antagonists, Stable Angina Pectoris, Medication Adherence
- What is being tested?
- Patient support tool
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 432 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2019to 1 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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;
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Adrenergic Beta-Antagonists, Stable Angina Pectoris, Medication Adherence, Mobile Applications
- Being tested
- Patient support tool
- Keywords
- beta-blocker, Stable Angina Pectoris, Patient support tool, Adherence
- Medical subject headings
- Angina, Stable, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 weeks
Secondary outcomes (3)
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.
Measured: 24 weeks
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.
Measured: 24 weeks
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.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2019
- Study start1 Apr 2019 (estimated)
- Primary completion1 Sep 2020 (estimated)
- Study completion1 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adrenergic Beta-AntagonistsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 432 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenyang Northern Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Han Yaling, Shenyang Northern Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03794713
- Sponsor's protocol ID
- SUPPORT V1.0
- Status last verified
- Jan 2019
- First submitted
- 3 Jan 2019
- Last updated
- 7 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03794713
- Acronym / sponsor ID
- SUPPORT V1.0
- Conditions
- Adrenergic Beta-Antagonists, Stable Angina Pectoris, Medication Adherence, Mobile Applications
- Keywords
- beta-blocker, Stable Angina Pectoris, Patient support tool, Adherence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 432 participants (estimated)
- Lead sponsor
- Shenyang Northern HospitalUniversity, hospital or other
- Study start
- 1 Apr 2019 (estimated)
- Primary completion
- 1 Sep 2020 (estimated)
- Study completion
- 1 Sep 2020 (estimated)
- First posted
- 7 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient support tool group | Experimental | Device: Patient support toolSubjects were managed the HR by using the Patient Support Tool through a smart phone application and a wristband and be guided by physicians |
| 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient support toolThe 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. | Device | Patient support tool group |
Primary outcome
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.
3 secondary outcomes
Impact of resting heart rate
Time frame: 24 weeks
Impact of angina attacks
Time frame: 24 weeks
Major adverse cardiovascular events
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2019.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Patient support tool in people with Adrenergic Beta-Antagonists and Stable Angina Pectoris, run by Shenyang Northern Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jing Li, MD (86-024-28897309, lijing790126@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to beta-blockers (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2019; AzTrials last refreshed its copy on 26 Oct 2026.