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

NCT03207646 | Terminated

• 1 other identifier: 39555
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Acute Coronary Syndrome

Keywords

Cardiac Rehabiliation; Percutaneous Coronary Intervention; Cardiovascular Risk Factor; Digital Health Solution; Medication Adherence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Medication adherence II

  Baseline through End of Study visit - approximately 90 days per participant.

• Medication adherence III

  Baseline through End of Study visit - approximately 90 days per participant.

• Medication adherence IV

  Baseline through End of Study visit - approximately 90 days per participant.

• Medication adherence V

  Baseline through End of Study visit - approximately 90 days per participant.

• Medication persistence

  Baseline through End of Study visit - approximately 90 days per participant.

Study Arms (2)

smartphone-based cardiac rehabilitation

EXPERIMENTAL

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®

Control

NO INTERVENTION

Standard-of-care alone.

Interventions

BrightHeart® OTHER

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.

smartphone-based cardiac rehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford Healthcare

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease; Acute Coronary Syndrome; Medication Adherence

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Minang (Mintu) Turakhia, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Cardiovascular Medicine

Model Details: Participants will be randomized 1:1 to either the experimental arm or the 'no intervention' (control) arm.

Study Record Dates

• First Submitted: June 16, 2017
• First Posted: July 5, 2017
• Study Start: July 19, 2017
• Primary Completion: May 9, 2018
• Study Completion: August 17, 2018
• Last Updated: September 10, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)