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

Last updated: September 6, 2018
Sponsor: Stanford University
Overall Status: Terminated

Phase

N/A

Condition

Vascular Diseases

Atherosclerosis

Angina

Treatment

N/A

Clinical Study ID

NCT03207646
39555
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion criteria: I. ≥ 18 years of age II. Patient at Stanford Health Care with evidence of CAD (atherosclerosis of one or morecoronary arteries or clinical evidence or documentation of ischemia, infarction) OR adiagnosis 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 atleast 3 months following discharge IV. Possession of a compatible (iPhone 5s or later; OS 8.1 or higher) smartphone with anactive phone number and data plan. The smartphone must be in continued possession of theparticipant. It may not be a shared device and must exclusively remain in the possession ofthe participant during the study period. The smartphone must have an active cellular phonenumber and cellular data subscription. Wi-Fi internet capability is not a substitute for anactive cellular data plan. V. Must sign an informed consent form (ICF) indicating that he or she understands thepurpose of, and procedures required for, the study and is willing to participate in thestudy. VI. Willing to have the mobile application installed on a smartphone and use it every dayduring the entire study period VII. Willing to provide oral confirmation indicating thathe/she is currently not using a medication adherence application. VIII. Ability to read and understand English.

Exclusion

Exclusion criteria: Any potential participant who meets any of the following criteria will be excluded fromparticipating in the study: I. Anticipated inability to adhere to the mobile application (BrightHeart®) based onopinion of site Principal Investigator (PI). II. Current use of adherence tracking devices, electronic, smartphone or computerapplications, including but not limited to smart pill bottles, pill timers, radiofrequencytagged medications or dispensers, mobile applications, or automated phone reminders. Pillorganizers that remind participants when to take medicine with beeps or alerts areexclusion. a. Note: Pharmacy and health care plan automated refill reminders are permitted and are notexclusion. Pill organizers or containers that only compartmentalize a participant'smedications based on days of the week are not exclusion. III. Cognitive, visual, hearing, voice, or motor impairment that would prevent completionof study procedures or use of mobile phone. Co-morbidities that would precludeparticipation (e.g. ongoing chemotherapy) or planned hospitalization for complex proceduresas determined by the PI (e.g. bypass, valve or aortic surgery, transarterial valvereplacement) IV. End-stage of one of the following: heart failure (using left ventricularassist device or listed for heart transplantation), renal disease, lung disease, liverdisease. V. Any condition with a life expectancy less than 3 months. VI. Employee of theinvestigator or study site, with direct involvement in the proposed study or other studiesunder the direction of that investigator or study site, as well as family members of theemployees or the investigator VII. Any other condition as determined by the PI.

Study Design

Total Participants: 63
Study Start date:
July 19, 2017
Estimated Completion Date:
August 17, 2018

Study 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.

Connect with a study center

  • Stanford Healthcare

    Stanford, California 94305
    United States

    Site Not Available

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