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Smartphone GUIded MeDication AdherencE and Rehabilitation in Patients With Coronary Artery Disease
Trial ID: NCT03207646
This study evaluates a smartphone-based cardiac rehabilitation program in adults with coronary artery disease. Half of patients will participate in a smartphone-based cardiac rehabilitation program while the other half will receive standard-of-care.
Smartphone GUIded MeDication AdherencE and Rehabilitation in Patients With Coronary Artery Disease (smartGUIDE)
I. ≥ 18 years of age
II. Patient at Stanford Health Care with evidence of CAD (atherosclerosis of one or more
coronary arteries or clinical evidence or documentation of ischemia, infarction) OR a
diagnosis related to CAD (i.e. ischemic heart disease ICD-10-Code: I20-25).
III. Prescription of a P2Y12 antagonist and/or a statin for an anticipated duration of at
least 3 months following discharge
IV. Possession of a compatible (iPhone 5s or later; OS 8.1 or higher) smartphone with an
active phone number and data plan. The smartphone must be in continued possession of the
participant. It may not be a shared device and must exclusively remain in the possession of
the participant during the study period. The smartphone must have an active cellular phone
number and cellular data subscription. Wi-Fi internet capability is not a substitute for an
active cellular data plan.
V. Must sign an informed consent form (ICF) indicating that he or she understands the
purpose of, and procedures required for, the study and is willing to participate in the
VI. Willing to have the mobile application installed on a smartphone and use it every day
during the entire study period VII. Willing to provide oral confirmation indicating that
he/she is currently not using a medication adherence application.
VIII. Ability to read and understand English.
Any potential participant who meets any of the following criteria will be excluded from
participating in the study:
I. Anticipated inability to adhere to the mobile application (BrightHeart®) based on
opinion of site Principal Investigator (PI).
II. Current use of adherence tracking devices, electronic, smartphone or computer
applications, including but not limited to smart pill bottles, pill timers, radiofrequency
tagged medications or dispensers, mobile applications, or automated phone reminders. Pill
organizers that remind participants when to take medicine with beeps or alerts are
a. Note: Pharmacy and health care plan automated refill reminders are permitted and are not
exclusion. Pill organizers or containers that only compartmentalize a participant's
medications based on days of the week are not exclusion.
III. Cognitive, visual, hearing, voice, or motor impairment that would prevent completion
of study procedures or use of mobile phone. Co-morbidities that would preclude
participation (e.g. ongoing chemotherapy) or planned hospitalization for complex procedures
as determined by the PI (e.g. bypass, valve or aortic surgery, transarterial valve
replacement) IV. End-stage of one of the following: heart failure (using left ventricular
assist device or listed for heart transplantation), renal disease, lung disease, liver
V. Any condition with a life expectancy less than 3 months. VI. Employee of the
investigator or study site, with direct involvement in the proposed study or other studies
under the direction of that investigator or study site, as well as family members of the
employees or the investigator VII. Any other condition as determined by the PI.
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