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)
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|ClinicalTrials.gov Identifier: NCT03794713|
Recruitment Status : Not yet recruiting
First Posted : January 7, 2019
Last Update Posted : January 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Adrenergic Beta-Antagonists Stable Angina Pectoris Medication Adherence Mobile Applications||Device: Patient support tool||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||432 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
- 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.
- 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.
- 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.
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
|Contact: Jing Li, MDfirstname.lastname@example.org|