Clinical trial NCT03207646: Smartphone GUIded MeDication AdherencE and Rehabilitation in Patients With Coronary Artery Disease
Official title: Smartphone GUIded MeDication AdherencE and Rehabilitation in Patients With Coronary Artery Disease (smartGUIDE)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Coronary Artery Disease
Acute Coronary Syndrome
Keywords: Cardiac Rehabiliation
Percutaneous Coronary Intervention
Cardiovascular Risk Factor
Digital Health Solution
Medication Adherence
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2017-07-05
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized 1:1 to either the experimental arm or the 'no intervention' (control) arm.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: Cardiac rehabilitation as a means to improve lifestyle-based risk factor modification, remains poorly prescribed and utilized, often due to the lack of access to programs, poor insurance coverage, cost, or patient or physician motivational factors. Low-cost solutions that can improve patient adherence to medications, risk factor reduction, and exercise could improve cardiovascular outcomes and cost-effectiveness compared to current care models.

Eligibility criteria: Inclusion criteria:

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 study.

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.

Exclusion criteria:

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 exclusion.

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 disease.

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.

Primary outcomes:
measure: Medication adherence
timeFrame: Baseline through End of Study visit - approximately 90 days per participant.
Secondary outcomes:
measure: Medication adherence II
timeFrame: Baseline through End of Study visit - approximately 90 days per participant.
measure: Medication adherence III
timeFrame: Baseline through End of Study visit - approximately 90 days per participant.
measure: Medication adherence IV
timeFrame: Baseline through End of Study visit - approximately 90 days per participant.
measure: Medication adherence V
timeFrame: Baseline through End of Study visit - approximately 90 days per participant.
measure: Medication persistence
timeFrame: Baseline through End of Study visit - approximately 90 days per participant.
measure: Cardiovascular risk factors I
timeFrame: Baseline through End of Study visit - approximately 90 days per participant.
measure: Cardiovascular risk factors II
timeFrame: Baseline through End of Study visit - approximately 90 days per participant.
measure: Cardiovascular risk factors III
timeFrame: Baseline through End of Study visit - approximately 90 days per participant.
measure: Cardiovascular risk factors IV
timeFrame: Baseline through End of Study visit - approximately 90 days per participant.
measure: Cardiovascular risk factors V
timeFrame: Baseline through End of Study visit - approximately 90 days per participant.
measure: Cardiovascular risk factors VI
timeFrame: Baseline through End of Study visit - approximately 90 days per participant.
measure: Cardiovascular risk factors VII
timeFrame: Baseline through End of Study visit - approximately 90 days per participant.
measure: Exploratory I: Rehospitalization
timeFrame: Baseline through End of Study visit - approximately 90 days per participant.
measure: Exploratory II: Cardiovascular outcomes
timeFrame: Baseline through End of Study visit - approximately 90 days per participant.
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford Healthcare
state: California
Study officials:
affiliation: Stanford University
name: Minang (Mintu) Turakhia, MD
role: PRINCIPAL_INVESTIGATOR
References: