Smartphone GUIded MeDication AdherencE and Rehabilitation in Patients With Coronary Artery Disease (smartGUIDE)

Smartphone GUIded MeDication AdherencE and Rehabilitation in Patients With Coronary Artery Disease (smartGUIDE)

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.

Study Overview

• Status: Terminated
• Conditions: Coronary Artery Disease; Acute Coronary Syndrome
• Intervention / Treatment: Other: BrightHeart®

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.

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford Healthcare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: smartphone-based cardiac rehabilitation; The BrightHeart® mobile application is installed on the smartphone and a heart coach set up and guides the participant through a cardiac care program.	Other: BrightHeart®; BrightHeart® has two components: smartphone mobile based application and a human coach. It is a combined approach of medication adherence, exercise, diet, sleep and stress reduction.
No Intervention: Control; Standard-of-care alone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication adherence	The proportion of days coverd (PDC) expressed as a percentage but considered as a continuous variable of the composite of the prescribed P2Y12 receptor antagonist and/or the statin.	Baseline through End of Study visit - approximately 90 days per participant.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication adherence II	Proportion of participants with PDC ≥ 80% of the composite of the P2Y12 receptor antagonist and/or the statin	Baseline through End of Study visit - approximately 90 days per participant.
Medication adherence III	The PDC of each medication of the composite	Baseline through End of Study visit - approximately 90 days per participant.
Medication adherence IV	Proportion of participants with PDC ≥ 80% of each of the composite	Baseline through End of Study visit - approximately 90 days per participant.
Medication adherence V	Mean time from discharge to first fill	Baseline through End of Study visit - approximately 90 days per participant.
Medication persistence	proportion of patients with an active prescription at three months of a statin and P2Y12 inhibitor	Baseline through End of Study visit - approximately 90 days per participant.
Cardiovascular risk factors I	Serum LDL-C at End of Study	Baseline through End of Study visit - approximately 90 days per participant.
Cardiovascular risk factors II	Proportion of participants within target blood pressure (<140/90 mmHg or <130/80 mmHg for patients with diabetes mellitus or chronic kidney disease) at End of Study	Baseline through End of Study visit - approximately 90 days per participant.
Cardiovascular risk factors III	Proportion of participants with HbA1c ≤ 7% at End of Study (only if diabetes mellitus was known at time of inclusion)	Baseline through End of Study visit - approximately 90 days per participant.
Cardiovascular risk factors IV	Change in body weight from baseline to End of Study	Baseline through End of Study visit - approximately 90 days per participant.
Cardiovascular risk factors V	Change in quality of life (measured by EQ-5D-3L14) from day 3-10 after discharge to End of Study	Baseline through End of Study visit - approximately 90 days per participant.
Cardiovascular risk factors VI	Change in patient activation (measured by PAM®1015) from day 3-10 after discharge to End of Study	Baseline through End of Study visit - approximately 90 days per participant.
Cardiovascular risk factors VII	Physical activity at End of Study (measured by a physical acitivity questionnaire)	Baseline through End of Study visit - approximately 90 days per participant.
Exploratory I: Rehospitalization	30-day rehospitalization for any reason	Baseline through End of Study visit - approximately 90 days per participant.
Exploratory II: Cardiovascular outcomes	Major adverse cardiac events (MACE) defined as: Death, myocardial infarction, acute coronary syndrome, out of hospital cardiac arrest, stent thrombosis, repeat revascularization at 90 days	Baseline through End of Study visit - approximately 90 days per participant.

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Minang (Mintu) Turakhia, MD, Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2017
• Primary Completion (Actual): May 9, 2018
• Study Completion (Actual): August 17, 2018

Study Registration Dates

• First Submitted: June 16, 2017
• First Submitted That Met QC Criteria: June 30, 2017
• First Posted (Actual): July 5, 2017

Study Record Updates

• Last Update Posted (Actual): September 10, 2018
• Last Update Submitted That Met QC Criteria: September 6, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Percutaneous Coronary Intervention; Medication Adherence; Cardiovascular Risk Factor; Cardiac Rehabiliation; Digital Health Solution
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Acute Coronary Syndrome
• Other Study ID Numbers: 39555

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
• product manufactured in and exported from the U.S.: No